Special Report – Rheumatoid Arthritis and Severe Psoriasis Treatment

Special Report

Rheumatoid Arthritis and Severe Psoriasis Treatment

The Clinical and Economic Benefits of Switching from Oral to Subcutaneous Methotrexate Therapy in Patients with Rheumatoid Arthritis or Psoriasis Not a Death Sentence Based on Evidence Duty of Care Unchanged Dealing with the Problem as well as the Symptoms Sponsored by

Published by Global Business Media

SPECIAL REPORT

Rheumatoid Arthritis and Severe Psoriasis Treatment

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Contents Foreword

2

John Hancock, Editor The Clinical and Economic Benefits of Switching from Oral to Subcutaneous Methotrexate Therapy in Patients with Rheumatoid Arthritis or Psoriasis Not a Death Sentence Based on Evidence Duty of Care Unchanged Dealing with the Problem as well as the Symptoms Sponsored by

Published by Global Business Media

Published by Global Business Media Global Business Media Limited 62 The Street Ashtead Surrey KT21 1AT United Kingdom Switchboard: +44 (0)1737 850 939 Fax: +44 (0)1737 851 952 Email: info@globalbusinessmedia.org Website: www.globalbusinessmedia.org Publisher Kevin Bell Business Development Director Marie-Anne Brooks Editor John Hancock Senior Project Manager Steve Banks Advertising Executives Michael McCarthy Abigail Coombes Production Manager Paul Davies For further information visit: www.globalbusinessmedia.org The opinions and views expressed in the editorial content in this publication are those of the authors alone and do not necessarily represent the views of any organisation with which they may be associated.

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The Clinical and Economic Benefits of Switching from Oral to Subcutaneous Methotrexate Therapy in Patients with Rheumatoid Arthritis or Psoriasis 3 R Fitzpatrick, Clinical Director Pharmacy, Royal Wolverhampton Hospitals, New Cross Hospital, Wolverhampton, UK

Introduction Clinical Evidence in Support of Subcutaneous Over Oral Administration of MTX Clinical Risk Management Strategies Summary medac GmbH, UK Branch

Not a Death Sentence

8

John Hancock

Prevalence, Impact and Frequency Early Diagnosis is Good Holistic Approach to Treatment Family Support Helps A Manageable Condition

Based on Evidence

10

Camilla Slade, Staff Writer

Limitations and Progress of the Condition Treatment Grounded in Experience Drugs that Work Limiting the Downside Living with the Condition

Duty of Care Unchanged

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John Hancock

Treat the Patient Early Diagnosis: Difficult but Important Living as Well as Possible Not Drugs Alone Same Care: New Delivery

Dealing with the Problem as well as the Symptoms

14

Peter Dunwell, Medical Correspondent

Patients Need Support Drawing on a Range of Skills Balancing Needs with Treatments

References 16

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Foreword

N

either of the related conditions covered in

both as regards patient satisfaction and from an

this Special Report is numerically prevalent

economic standpoint. It highlights the benefits of

in the UK but both can severely limit the quality

the subcutaneous drug, Metoject, which can lead

and, if not well managed, the length of life. Also,

to increased convenience for patients as well as

both can have a devastating impact on the patient’s

savings to healthcare services.

self-esteem because both rheumatoid arthritis

With the advent of GP commissioning in the NHS,

and psoriatic arthritis with psoriasis affect ability

the principle ‘no decision about me, without me’

to perform the normal functions of life and present

becomes central to any treatment in this, as in

symptoms that alter the appearance of the patient.

most, healthcare programmes. GPs will be able

While neither condition can, as yet, be cured, both

to work with their patients, putting those patients at

can be managed with a structured programme

the heart of the treatment programme for decisions,

of therapy ranging from psychological support,

times, therapy choices and in the use of the correct

through a range of treatments to a drug regime

drugs. This empowers both parties but also puts

which, if properly administered, can slow or halt

on them both a responsibility to understand and

the progress of the condition.

monitor the progress of any programme.

The most commonly used disease-modifying anti-

With the benefit of evidence-based practice,

rheumatic drug is Methotrexate (MTX), which can

that task will be made more straightforward using

be administered via either oral or parenteral routes.

therapies and drug treatments that have already

However, a significant number of patients fail to

proved their efficacy in helping rheumatoid and

respond to or tolerate oral MTX. In such cases, there

psoriatic arthritis patients.

is a growing body of evidence in support of a switch from oral to subcutaneous administration. The opening piece in this Report details the advantages

John Hancock

of subcutaneous over oral administration of MTX

Editor

John Hancock has been Editor of Primary Care Reports since its launch. A journalist for nearly 25 years, John has written and edited articles, papers and books on a range of medical and management topics. Subjects have included management of long-term conditions, elective and non-elective surgery, Schizophrenia, health risks of travel, local health management and NHS management and reforms – including current changes.

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

The Clinical and Economic Benefits of Switching from Oral to Subcutaneous Methotrexate Therapy in Patients with Rheumatoid Arthritis or Psoriasis R Fitzpatrick, Clinical Director Pharmacy, Royal Wolverhampton Hospitals, New Cross Hospital, Wolverhampton, UK.

This article reviews the changing perspectives on the treatment of RA and psoriasis and the important clinical and economic impact of switching from oral to subcutaneous methotrexate if there is intolerance or a deficient response to initial therapy.

Introduction Methotrexate (MTX) is the most commonly used disease-modifying anti-rheumatic drug (DMARD) in rheumatoid arthritis (RA) and has been widely used in the treatment of psoriasis due to its favourable efficacy and tolerability profile. MTX, which can be administered via oral or parenteral routes, is currently recommended as first-line therapy for RA1,2 and in the treatment of severe or refractory psoriasis.3,4 Patients are commonly prescribed oral MTX; however, a significant number of them fail to respond to or tolerate this formulation and are often switched to more costly therapies to control their disease.

However, this approach means that patients may not be deriving the full benefit from MTX therapy, which has not only been shown to be an effective therapy for RA and psoriasis, but also to decrease the incidence of cardiovascular disease more effectively than other DMARDs and biologics.5 Recent therapeutic expert reviews and consensus opinion advocate a switch from oral to subcutaneous routes of MTX if there is intolerance or a deficient response to initial therapy.6,7,8,9,10,11 Practical guidance also supports the use of the subcutaneous route12 on the basis of the beneficial pharmacological and clinical profile of this route of administration (Table 1).

• Improving bioavailability and tolerance of MTX13 • Achieving higher response rates14 • Reducing the side-effects from oral administration15 • Sustaining treatment with MTX to extend the time before more costly therapies need to be introduced to control disease6 • Reducing healthcare costs16 • Improving patient satisfaction, and enhancing patient independence17 • Providing a less painful route for parenteral administration (subcutaneous route)12 Table 1: Rationale for administering subcutaneous MTX

Clinical Evidence in Support of Subcutaneous Over Oral Administration of MTX There is a growing body of evidence in support of subcutaneous over oral administration of MTX in RA patients. 6,7,14 Although there is relative paucity of data on switching patients with psoriasis from oral to subcutaneous MTX, findings from a systematic review recommend subcutaneous MTX at the same oral dosing where inadequate response is obtained or in the event of poor gastrointestinal tolerance.11 www.primarycarereports.co.uk | 3

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

subcutaneous over oral administration of MTX in RA patients.

Biologic initiation

of evidence in support of

SC MTX initiation

There is a growing body

Monitoring costs

£4.262

Drug costs

£6.194

Total

£10.455

Monitoring costs

£3.409

Drug costs

£26.065

Total

£29.474 0

5.0

10.0

15.0 20.0 Total costs (£millions)

25.0

30.0

35.0

Cost savings through use of Metoject® £19,018,813 Figure 1: Total cost comparisons of subcutaneous MTX and biologic (continuation and failure costs combined)

More Effective Than Oral MTX Data from a 6-month, multicentre, randomised, double-blind, controlled trial undertaken by Braun et al14 indicate that subcutaneous MTX is more effective than oral MTX in RA patients. At week 24, significantly more patients treated with subcutaneous MTX than with oral MTX showed ACR20 (78% vs. 70%) and ACR70 (41% vs. 33%) responses. In ACR20 non-responders, the switch from oral to subcutaneous MTX and the switch from a lower dosage of subcutaneous MTX to a higher dosage of subcutaneous MTX were also found to be effective in 30% and 23% of patients, respectively.14

Reduces the Side-Effects Seen With Oral MTX Further evidence of the beneficial effect of switching from oral MTX to subcutaneous MTX comes from a study undertaken in RA patients who were initially treated with oral MTX 7.5 mg or 15 mg weekly before switching to a corresponding dose of subcutaneous MTX due to gastrointestinal side-effects (e.g. nausea, vomiting, diarrhoea, loss of appetite, and abdominal pain).15 Patients receiving oral MTX reported more intense gastrointestinal sideeffects than patients receiving subcutaneous MTX. A correlation between dose of oral MTX and intensity of side-effects was also observed.15

Extends the Time on MTX Before More Costly Therapies Need to be Introduced Evidence supporting the use of subcutaneous MTX in RA patients who had previously failed 4 | www.primarycarereports.co.uk

oral therapy either due to lack of efficacy or side-effects, most commonly gastrointestinal intolerance, comes from a UK study by Mainman et al.6 Data show that 76% of patients in whom the efficacy of parenteral therapy was assessed would have met criteria for the use of biologic therapy at baseline and that most of these patients responded sufficiently well to parenteral MTX after 6 months of therapy to avoid the need for biologic therapy.6

Results in Significant Savings to the NHS Through Reduced Need for Biologic Therapy An economic analysis was undertaken to assess the economic impact of either subcutaneous MTX or a biologic in oral MTX failure patients suitable for biologic therapy using a 12-month perspective.16 The model was developed from a UK perspective using NHS costs. Where data were unavailable or inconclusive, assumptions were applied and subsequent sensitivity analyses were undertaken. Data show that the routine use of subcutaneous MTX has the potential to save the NHS an estimated £6,561 per patient in the first year of therapy, equating to £19 million per year nationally, through reduced need for biologic therapy (Figure 1).16 These results are further supported by data from the real-life setting, which were presented at the EULAR Annual Rheumatology Congress of Rheumatology in 2011.7 The Methotrexate SC Evaluation of Norwich Treatment Outcomes in RA (MENTOR) study evaluated the clinical outcome of 149 patients with RA who had switched from oral MTX to subcutaneous MTX either due to

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Hospital dispensed, hospital administered

£25.059

Community dispensed, hospital administered

£24.351

Homecare

£7.442

Hospital dispensed, self-administered

£6.968

Primary care

£6.260

0.0 n=3813

5.0

10.0

15.0

20.0

25.0

30.0

Total annual cost of different service provision options (£million)

Figure 2: Comparative costs of primary care-based versus hospital-based services based on a defined population of 3,813 patients

lack of efficacy or unacceptable side-effects, or a combination of both.7 An interim analysis of the data showed that following the switch, 72% of patients continued on subcutaneous MTX over an extended time period of more than 4 years. Furthermore, ≤20% of patients required an additional DMARD or a biologic whilst on subcutaneous MTX.7

Self-Administration of Subcutaneous MTX at Home Improves Patient Satisfaction and is the Most CostEffective Service Provision Option

approach should be adopted for the majority of patients treated with subcutaneous MTX.20

Clinical Risk Management Strategies In recent years there have been reports of prescription and dispensing errors for oral MTX, which have resulted in serious and fatal adverse reactions and have also led to patients taking overdoses of MTX with associated adverse effects.21 Risk assessment and management is therefore an integral aspect of providing safe and effective health care.12

Metoject® 50 mg/ml (medac GmbH) is the licensed form of subcutaneous MTX, which is indicated for the treatment of active RA in adult patients and severe recalcitrant disabling psoriasis not adequately responsive to other forms of therapy.18 Studies have shown that self-administration of subcutaneous MTX at home reduces hospital visits, is more convenient for patients with RA and psoriasis, and improves patient satisfaction.17,19 Furthermore, should Metoject be adopted, a recent economic study has shown that a primary care-based service is a cheaper option than a hospital-based service from a payer’s perspective (Figure 2).20 This study was undertaken to model the direct costs of treatment comparing alternative systems of service provision currently in use in the UK, over a 12-month period on a defined population of RA patients who had failed oral MTX and were given Metoject. A primary care-based service was found to save a total of £18,798,691 per year versus delivery in a hospital outpatient setting. It is therefore recommended that this www.primarycarereports.co.uk | 5

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Studies have shown that self-administration of subcutaneous MTX at home reduces hospital visits, is more convenient for patients with RA and psoriasis, and improves patient satisfaction.

Metoject, which is given as a weekly injection, can be self-administered at home after adequate training and has a number of beneficial features to enhance safety and facilitate patients’ independence (Table 2). To facilitate the administration of Metoject and enable patients to self-inject safely at home, an increasing number of nurse-led teaching packages, shared-care protocols and safety guidelines have been established for the primary care setting.

• Securely packaged pre-filled syringe, which makes it easier to use • Can be self-administered at home after adequate training, facilitating independence • Clearly labelled packaging helps prevent dosing errors • Can be stored at room temperature for up to 2 years • Barrel incorporates a pair of large ‘wings’, enabling users with limited dexterity to more easily manipulate the device and self-administer their treatments • Available in 10 doses from 7.5 mg – 30 mg Table 2: Beneficial features of Metoject

Summary It is important to utilise the full potential of any drug before switching to another drug to enhance patient outcomes. Subcutaneous MTX can be successfully used in patients who fail to respond to or tolerate oral MTX and therefore, it has an important role to play in the long-term management of patients with RA and psoriasis. In addition, routine use of subcutaneous MTX prior to biologic therapy has the potential not only to control effectively disease but to lead to increased convenience for patients and families and cost savings to healthcare services.

medac GmbH, UK Branch Scion House Stirling University, Innovation Park, Stirling FK9 4NF Phone number: +44 (0) 1786 458086 Fax number: +44 (0) 1786 458032 E-mail: info@medac-uk.co.uk Website: www.medacuk.com

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

References: 1

National Collaborating Centre for Chronic Conditions. Rheumatoid arthritis: national clinical guideline for

2

Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of

management and treatment in adults. London. Royal College of Physicians, February 2009. rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010;69:964-975.

3

Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults. A national clinical guideline. October 2010. Available at: www.sign.ac.uk/pdf/sign121. pdf [Accessed March 2012)

4

National Institute for Health and Clinical Excellence. Etanercept and efalizumab for the treatment of

5

Hochberg MC, Johnston SS, John AK. The incidence and prevalence of extra-articular and systemic

adults with psoriasis. NICE technology appraisal guidance 103. manifestations in a cohort of newly-diagnosed patients with rheumatoid arthritis between 1999 and 2006. Curr Med Res Opin 2008;24:469-480.

6

Mainman H, McClaren E, Heycock C, et al. When should we use parenteral methotrexate?

7

Scott DGI, Claydon P, Buchan S. A retrospective study of the effects of switching from oral to

Clin Rheumatol 2010;29:1093-1098. subcutaneous (SC) methotrexate (MTX): interim analysis of the Methotrexate Evaluation of Norwich Treatment Outcomes in RA (MENTOR) study. Additional information in support of Abstract No: EULAR11-5653 presented at the EULAR Annual European Congress of Rheumatology, 2011, London, UK. 8

Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol 2009;61:451-485.

9

Jancin B. Try ‘SubQ Switch’ for oral methotrexate nonresponders. March 2011. Available at: www. rheumatologynews.com [Accessed March 2012].

10

Paul C, Gallini, A, Maza A, et al. Evidence-based recommendations on conventional systemic treatments in psoriasis: a systematic review and expert opinion of a panel of dermatologists. J Eur Acad Dermatol Venereol 2011;25(2 Suppl):2-11.

11

Montaudié H, Sbidian E, Paul C, et al. Methotrexate in psoriasis: a systematic review of treatment modalities, incidence, risk factors and monitoring of liver toxicity. J Eur Acad Dermatol Venereol 2011;25(Suppl 2):12-18.

12

Royal College of Nursing. Administering subcutaneous methotrexate for inflammatory arthritis.

RCN guidance for nurses.

Available at: www.rcn.org.uk/__data/assets/pdf_file/0011/78608/002269.pdf [Accessed March 2012].

13

Hoekstra M, Haagsma C, Neef C, et al. Biovailability of higher dose methotrexate comparing oral and

14

Braun J, Kästner P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous

subcutaneous administration in patients with rheumatoid arthritis. J Rheumatol 2004;31:645-648. versus oral administration of methotrexate in patients with active rheumatoid arthritis. Results of a sixmonth, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum 2008;58:73-81.

Rutkowska-Sak L, Rell-Bakalarska M, Lisowska B. Oral vs. subcutaneous low-dose methotrexate

15

treatment in reducing gastrointestinal side effects. Reumatologia 2009;47:207-211.

16

Fitzpatrick R, Buchan S. Optimising methotrexate (MTX) therapy and reducing total treatment costs in rheumatoid arthritis (RA). Poster P65, presented at the British Society of Rheumatology and the British Health Professionals in Rheumatology Annual Conference, 2011, Brighton, UK.

17

Striesow F, Brandt A. Preference, satisfaction and usability of subcutaneously administered methotrexate for rheumatoid arthritis or psoriatic arthritis: results of a postmarketing surveillance study with a high-concentration formulation. Ther Adv in Musculoskelet Dis 2012;4:3-9.

18

medac GmbH. Metoject Summary of Product Characteristics. October 2010.

19

Arthur V, Jubb R, Homer D. A study of parenteral use of methotrexate in rheumatic conditions. J Clin

20

Fitzpatrick R, Keary IP. The impact of service delivery options on the cost of subcutaneous methotrexate

Nurse 2002;11:256-263.

(MTX) for the management of rheumatoid arthritis (RA) patients. Poster P60, presented at the British Society of Rheumatology and the British Health Professionals in Rheumatology Annual Conference, 2011, Brighton, UK. National Patient Safety Agency. Improving compliance with oral methotrexate guidelines. Available at:

21

http://www.nrls.npsa.nhs.uk/resources/ [Accessed March 2012]. www.primarycarereports.co.uk | 7

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Not a Death Sentence John Hancock

While not the most prevalent health problem, rheumatoid arthritis can be life changing but needn’t be life threatening with the right treatment programme

‘There is evidence that the first 12 week period of the disease is immunologically distinct and represents a unique opportunity to influence the progress of the disease. The challenge for GPs is to recognise early symptoms and refer early.’

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R

heumatoid arthritis (RA) is a chronic, aggressive autoimmune disease and is the commonest inflammatory polyarthropathy (inflammation of joints condition) in the United Kingdom. That said, neither RA nor its related severe psoriasis condition, psoriatic arthritis (PsA), is that common. In more straightforward terms, it is a long-term disease in which, according to NICE (National Institute for Health and Clinical Excellence): ‘joints in the body become inflamed, causing pain, swelling and stiffness. It is known as an autoimmune disease because it is caused when the body’s immune system, which normally fights infection, starts to attack healthy joints.’1 Unfortunately, the condition can be painful and there is as yet no known cure but treatments have been developed to manage the progress of rheumatoid arthritis and to ameliorate the pain and symptoms that accompany it.

Prevalence, Impact and Frequency The UK sits roughly in the middle of the incidence scale where rheumatoid arthritis is concerned; throughout the industrial world prevalence ranges from 0.5 to 1.5% while in the UK about 1% of the population (c400,000) are sufferers. Incidence is relatively low with about 12,000 people developing RA every year in the UK. Women are nearly three times as likely to suffer as are men and this tends to be a condition of later life with peak onset in the fourth and fifth decades although occurrences can affect younger or older people. The good news is that the annual prevalence data shows a significant decline in new cases during recent years. From 1998 when the mean weekly incidence of rheumatoid arthritis presentations per 100,000 in the population was 1.68, itself quite low, by 2007 that incidence level had fallen to 0.67.

In his article ‘Rheumatoid arthritis: the importance of early diagnosis’ in RCGP (Royal College of General Practitioners) News, in July 2010, Dr Graham Davenport also points out that: “The disease has a significant impact on the economy with a third of sufferers choosing to stop work within two years of diagnosis due to pain

and disability. The estimated cost to the economy from work-related disability and sick leave due to rheumatoid arthritis is £8 billion per year. However, it is now accepted that early diagnosis and treatment can prevent joint destruction before irreversible changes have occurred.”2 Because prevalence is not high, NICE estimates that an average GP with a list of 2000 patients will only see one person newly diagnosed with RA in approximately every two years. So, while early diagnosis is considered a key factor in slowing and treating the condition, the average GP will not see many patients presenting with early symptoms of rheumatoid arthritis.

Early Diagnosis is Good NICE guidance emphasises that importance of early diagnosis and treatment.

‘There is evidence that the first 12 week period of the disease is immunologically distinct and represents a unique opportunity to influence the progress of the disease. The challenge for GPs is to recognise early symptoms and refer early.’3 Much of the impact on the healthcare system is driven by this imperative. NICE has published guidance on the standards of care for people with RA in which there is an emphasis on the early involvement of secondary care in establishing the diagnosis, ensuring driving the early use of DMARDs (Disease-modifying Anti-rheumatic Drugs) and ensuring full access to all available resources.

Holistic Approach to Treatment The impact on the healthcare system of treating rheumatoid arthritis sufferers can be seen in the areas covered by NICE guidance ‘The management of rheumatoid arthritis in adults’…

• Referral, diagnosis and investigations; • Communication and education; • The multidisciplinary team; • Pharmacological management; • Monitoring rheumatoid arthritis; • Timing and referral for surgery; • Diet and complimentary therapies.

The aim of rheumatoid arthritis treatment is to reduce inflammation in the joints, relieve pain, prevent or slow joint damage, reduce disability

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

guides to help patients self-administer

and provide support to help the patient live as active a life as possible. But of course the greatest impact is on the patient themselves.

As with any long-term complaint, patients will need a lot of support, not just clinically but also psychologically. The NICE guidance makes the point that living with arthritis can be a positive experience – although challenging at times. To live well with arthritis the patient must understand that, while their condition is their reality, it is still possible to have a full rewarding life. It’s mainly a matter of managing that life. It also means the patient working with their doctor to implement the agreed treatment plan and accepting that, while the condition cannot currently be prevented (because the exact trigger for RA is not yet known), it is possible to live with it.

Sometimes with rheumatoid arthritis, as with other long-term conditions, individual patients will want to try complimentary therapies and changes to diet. There is no strong evidence that their condition will benefit from either of these approaches but, as always, there may be some psychological value that the patient can gain from feeling in charge of at least this part of their treatment and there may well be some short-term symptomatic benefits. However these unconventional therapies should not replace conventional treatment or drugs.

Carol Eustace was diagnosed with arthritis at the age of 19 and is now a writer on and patient advocate for others who live with the condition. She has created a ten-point ‘Living with Arthritis Checklist’ which can be found in full at click here. Some of the ideas that she suggests include that patients should have

unshakable perseverance, that they should take time to decompress and that ‘feeling sorry for yourself’ isn’t an option4. She also advises that RA patients should have a manageable and accessible home environment and ‘Someone to turn to for emotional support’.

Family Support Helps As well as being a potential life changer for the patient, rheumatoid arthritis can have an impact on the whole of their family. Families speak of the reassurance of statistics at the early diagnosis, such as that only 5% of sufferers end up in a wheelchair or that the condition is manageable. Both are true but the condition can nonetheless severely restrict what a sufferer can contribute to the family, in physical terms at least, and the family have the distress of seeing their loved one suffering from the symptoms of RA such as pain, lack of mobility and fatigue. Good and supportive families learn to read the condition almost before the sufferer can and to try and arrange family affairs to minimise unnecessary stresses on the patient.

Working with the patient, taking an interest in the condition and researching for up-to-date information can at least make people feel that they are doing something.

A Manageable Condition While it would be wrong to minimise the severity of rheumatoid arthritis or psoriatic arthritis and its impact, it would be equally incorrect to be over pessimistic about the condition. Patients and their families can live with RA, albeit subject to careful management, sensible lifestyle adjustments and a proper clinical treatment programme. www.primarycarereports.co.uk | 9

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Based on Evidence Camilla Slade, Staff Writer

Current treatment for rheumatoid arthritis and psoriatic arthritis draws on successful experience to increase the chances for success

Evidence-based treatment (EBT) tries to specify the way in which decisions are taken based on whatever evidence there may be for a practice which is then rated for how scientifically sound it may be.

Limitations and Progress of the Condition It’s not often that a paper such as this would refer to a television play. But in Dennis Potter’s 1986 BBC mini-series, ‘The Singing Detective’, the main character was suffering from psoriatic arthritis, a condition from which Potter himself suffered. It perhaps showed the condition in its worst possible light but it did also bring to the public’s notice this comparatively rare but nonetheless potentially life changing condition.

Like rheumatoid arthritis, psoriasis comes about from an autoimmune disorder and is one of a number of complicating factors that can be suffered by arthritis patients.

Even without the complication of psoriasis, many people with rheumatoid arthritis (RA) will endure limited mobility and difficulties with everyday activities, including work. The prognosis is variable from patient to patient and the course of the condition will include periods of accelerated worsening interspersed with periods of remission. But approximately 40% of patients become disabled after 10 years and that may be worse in patients where diagnosis and the commencement of treatment are delayed or where the condition strikes a male under 30 years old. So the clinical approach to this condition is very important as are the means used to treat it: increasingly this is summarised as an ‘evidencebased local approach’ to treatment.

Treatment Grounded in Experience Evidence-based practice is the approach to treatment that looks for that which has worked. For clinicians it is a more demanding approach as it requires them to keep up with the latest practices.

It also requires the efforts of a multidisciplinary team because what has worked might well be the result of treatments from different parts of the clinical process to address different aspects of the psoriatic arthritis or rheumatoid arthritis.

Similarly, evidence-based treatment (EBT) tries to specify the way in which decisions are taken based on whatever evidence there may be for a

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practice which is then rated for how scientifically sound it may be. It might be described as informed natural selection.

The local element in treatment is derived from including factors that relate to the patient in deciding which treatments will be appropriate.

As the NICE guidelines put it; ‘Many different medicines are used to treat rheumatoid arthritis. Some aim to relieve symptoms and others help slow the progression of the condition. Everyone experiences rheumatoid arthritis differently, so it may take time to find the best combination of medicines [and therapies for a particular patient’s needs].’5 Basing treatment on what works extends to basing medicines also on what has been found to work. Pharmacological management may well include painkillers which can control the sensory symptoms of rheumatoid arthritis. But they can only address symptoms. Another group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs) can relieve both pain and swelling in the joints but, again, they cannot slow down the progress of the condition. Where NSAIDs cannot provide sufficient relief, the patient may be prescribed a short term course of corticosteroids but as these can have serious side effects they cannot be used in the long-term.

Drugs that Work The most effective medication in treating rheumatoid arthritis is a group of drugs known as disease-modifying anti-rheumatic drugs (DMARDs) which NICE explains can help to ease symptoms and slow down the progression of rheumatoid arthritis.

‘When antibodies attack the tissue in the joints, they produce chemicals that can cause further damage to the bones, tendons, ligaments and cartilage. DMARDs work by blocking the effects of these chemicals. The earlier [a patient starts] taking a DMARD, the more effective it will be.’6 There are a number of drugs in this group including methotrexate, gold, leflunomide, hydroxychloroquine and sulfasalazine.

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

because one size doesn’t fit all...

Methotrexate is the drug most often given first in the treatment of rheumatoid arthritis either alone or combined with other treatments.

It can take four to six months before any noticeable improvements as a result of taking a DMARD so it is important that this should be explained to the patient to avoid them losing heart or, worse, stopping the medication before the initial course has finished. In fact, a patient and doctor may need to try several DMARDs to determine which will be suitable for the patient in the long-term.

As with many conditions, there are various other conventional and unconventional treatments which aim to address the underlying condition, symptoms or even the psychology of a patient and while there is little evidence that any of these alternative therapies can materially help, bearing in mind the local element of treatment, if the patient feels better using them and they do no harm then there is no reason not to use them.

Limiting the Downside But the reality is that the proven treatments such as DMARDs have a record of effectiveness in both halting the progress of rheumatoid arthritis

and psoriatic arthritis and assisting its long-term management. In evidence-based practice, that is what counts. Clearly this will achieve a better clinical outcome for the individual patient and a better lifestyle outcome for themselves and for their family. Furthermore, it may well mean that somebody with rheumatoid arthritis can continue working for longer than might otherwise have been the case.

Also, by managing and slowing down progress of the condition, use of DMARDs can limit the number of complications and other conditions in the patient suffering from rheumatoid and/ or psoriatic arthritis and that in turn will limit the degrees of treatment needed which will also be cost-effective for the healthcare service delivering treatment.

Living with the Condition While there is, as yet, no cure for rheumatoid and/ or psoriatic arthritis an evidence-based approach which takes into account the individual patient and includes treatments whose efficacy has already been proven, means that a diagnosis today need not mean the end of normal living but simply the need to incorporate some sensible steps into that normal living.

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Duty of Care Unchanged John Hancock

While NHS reforms might impact on how a GP delivers care to rheumatoid arthritis patients, it does not change the doctor’s basic task

Every patient experiences rheumatoid arthritis differently, so it may take time for the GP and patient working together to establish the best combination of therapies and medicines.

Treat the Patient One theme that has run throughout the whole debate surrounding NHS reform has been that all treatments should be centred around the patient and their needs. In line with the modern fondness for aphorisms, the term ‘no decision about me, without me’ has been coined. The March 2012 report on the subject from the Health Foundation, said that: “The case for ‘no decision about me…’ is clear in ethics and in policy and is supported by a growing evidence base. However, to make it an everyday experience for patients requires a significant change in philosophy, in culture and in the roles of patients and professionals.”7 For GPs, in particular, this marks a shift in responsibility from knowing to where in the system to direct their patient to working with that patient in creating a treatment programme for the condition, in this case rheumatoid arthritis (RA), appropriate for the patient and their circumstances. It means assembling a multidisciplinary team and managing the treatment delivery.

Early Diagnosis: Difficult but Important In the case of RA, GPs face an additional hurdle because a decline in the incidence of the condition means that there are a lot less occasions and a lot less frequent occasions when they will see a patient presenting with RA symptoms. An additional challenge in diagnosing RA can be found in the National Institute for Health and Clinical Excellence (NICE) guidance which states: “There is evidence that the first 12 week period of the disease is immunologically distinct and represents a unique opportunity to influence the progress of the disease. The challenge for GPs is to recognise early symptoms and refer early.”8 Those signs of early arthritis can vary and most patients do not visit their GP with the problem

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within that critical 12 week period. NICE has also published guidance on the standards of care for people with RA stating that, in addition to the early diagnosis, the GP should ensure: “Early involvement of secondary care… [and] early use of DMARDs [Disease-modifying Anti--rheumatic Drugs] and [ensure] full access to all available resources”.

This is not an easy one.

In one sense, including diagnosis as above, the distinct tasks involved in the GPs challenge in treating RA will not greatly change in the reformed NHS. An RA patient will still need to be referred to a specialist for proper analysis and understanding of the nature of their condition.

Equally the pharmacological regime for a patient will continue to involve a combination of painkillers, anti-inflammatory and disease modifying drugs.

Living as Well as Possible According to NICE, good rheumatoid arthritis care… ‘is to reduce the inflammation of the joints, relieve pain, prevent or slow joint damage, reduce disability and provide support to help [the patient] live as active a life as possible.’9 What has to be understood is that every patient experiences rheumatoid arthritis differently, so it may take time for the GP and patient working together to establish the best combination of therapies and medicines.

For the GP, being the entry point and manager for treatment, he or she will need to make sure that all of the patient’s needs are catered for including, in the case of RA patients, any psychological problems. These may arise from an increasing difficulty to undertake or complete physical tasks, fatigue and possible depression. The patient will also need guidance on diet and on other aspects of family life and relationships, and how these might be affected by their condition. All of this would be equally

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

true for the related severe psoriasis condition of psoriatic arthritis plus, of course, the need to take account of the effect of the skin condition itself on the patient’s daily life, what they wear and how other people react to them.

Not Drugs Alone As always when prescribing drugs, GPs need to consider overall factors related to those drugs.

For a DMARD such as methotrexate, the patient needs to understand that it can take four to six months for evidence to appear that the drug is working and there may be side effects including sickness, diarrhoea, mouth ulcers, hair loss, and rashes. Sometimes, according to NICE, methotrexate can have an effect on a patient’s blood count and liver so they would need to have regular blood tests. Less commonly, it can affect the lungs so the patient will also need to have a chest X-ray and breathing tests in addition to which the GP will need to be on the lookout for shortness of breath or persistent dry cough in the patient. That said, most people tolerate methotrexate well and it can be taken with biological treatments.

Similarly with non-steroidal anti-inflammatory drugs (NSAIDs) there may be side effects including internal stomach bleeding (not common). This can be countered using another medicine such as a proton pump inhibitor (PPI). Patients taking COX-2 agents will have a lower risk of stomach problems but a slightly higher risk of heart attack and stroke. Corticosteroids that help reduce pain and stiffness or swelling can cause weight gain and other side-effects particularly in diabetic patients.

Same Care: New Delivery If there is any rethink needed for GPs in the way they treat rheumatoid arthritis and psoriatic arthritis as a result of the NHS reforms it would be not so much in the nature of care – that remains much as it has always been – but it will be in the fact that the GP will now be in control of

pre-attached needle and colour coded backstop

and also be responsible and accountable for the suitability and efficacy of any treatment programme delivered to a patient. While presentations of RA symptoms are, thank goodness, quite rare in most GP practices, the principles of putting the patient at the centre of treatment programmes will apply just as much to these conditions as to any other.

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

Dealing with the Problem as well as the Symptoms Peter Dunwell, Medical Correspondent

Rheumatoid arthritis and psoriatic arthritis patients benefit from some well-established treatment guidelines that do not forget the importance of stopping progress of the condition

If patients have the ‘S-factor’ then early referral to the specialist is essential so that early aggressive treatment with DMARDs can be started urgently…

Patients Need Support There are approximately 400,000 people with rheumatoid arthritis (RA) in the UK with about 12,000 people developing the condition each year. While the peak age of incidence is people in their 70s, there are still many cases that develop at younger ages. For all patients, but perhaps especially for those who are still of working age and may have families to support, it is very important that, upon diagnosis of RA or of psoriatic arthritis (PsA), they feel that they are being supported in a framework for treatment of the condition and management of their lives with the condition.

The aim of RA and PsA care is to reduce inflammation in the joints, relieve pain, prevent or slow joint damage, reduce disability and provide support to help the patient live as active a life as possible. Lifestyle changes, drug and non-drug treatments, physiotherapy, regular exercise and surgery can all help.

The key in any treatment programme for these conditions is, as NICE and the Royal College of General Practitioners (RCGP) say that care should be ‘person-centred’ taking into account not only the drugs, therapies, support, counselling etc. but also patient preferences and needs. NICE says that: ‘People with RA should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals… Good communication between healthcare professionals and patients is essential.

It should be supported by evidence-based written information tailored to the person’s needs.’10

Drawing on a Range of Skills Writing in the July 2010 edition of RCGP news, Dr Graham Davenport addressed how GPs can apply recommendations and guidance from all sources. He explained how, “… representatives of the RCGP, the Rheumatology Futures Group, the Primary Care Rheumatology Society and Arthritis Research

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formed a working party to… Develop guidelines for both patients and GPs… [Resulting] in the S-factor poster campaign”11 which highlights the key signs of early inflammatory arthritis; Swelling, Stiffness and the Squeeze test. He goes on to add, “If patients have the ‘S-factor’ then early referral to the specialist is essential so that early aggressive treatment with DMARDs can be started urgently… GPs can support their patients to remain in work and help reduce the enormous burden of disability due to rheumatoid arthritis.”12 Psoriatic arthritis, because it includes additional problems, requires further guidance and additional treatment programmes to avoid tissue as well as joint destruction. Like RA, PsA is an autoimmune disorder which is why the two are closely associated both in diagnosis and treatment. With a 60% higher risk of mortality than the general population and a potential life expectancy some three years less than would otherwise be expected it is important that any treatment for this condition is properly planned and thoroughly delivered.

Most people with arthritis of any sort will feel discomfort, pain, stiffness and fatigue. These symptoms can be frustrating and upsetting, particularly if they lead to a loss of strength and grip, making it harder to move around and carry out daily tasks. So they may need to make some changes to their way of life, level of activity, health and nutrition.

Balancing Needs with Treatments GPs have a particular responsibility in the new NHS arrangements to coordinate and monitor a multidisciplinary care approach for RA and PsA. This means discussing with the patient the diagnosis, appropriate treatment, a pharmacological programme, additional therapies, and any other necessary support, given the patient’s circumstances. It also means ensuring that the patient not only understands

SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

their condition and what it means but is educated to understand why the agreed treatments are necessary, what they will do and what, if any, sideeffects there might be. Most of all, according to the NHS, ‘The management of rheumatoid arthritis in adults’ means providing ‘the opportunity for periodic assessments of the effect of the disease on [patient’s] lives (such as pain, fatigue, everyday activities, mobility, ability to work or take part in social order leisure activities, quality-of-life, mood, impact on sexual relationships) and help to manage the condition.’

It also means ensuring that the patient has an established path for those occasions when they suffer disease flares and offering a regular annual review to check for the presence or progress of any complicating conditions.

While much of the treatment framework is aimed at managing and helping the patient live with the condition, the pharmacological aspect of treatment addresses the sources of the discomfort and disabling conditions that make RA and PsA so potentially debilitating. Doctors have at their disposal a range of drugs which can be used in complimentary or progressive programmes to tackle the underlying problem and symptoms.

Painkillers address one of the more unpleasant symptoms while a non-steroidal anti-inflammatory drug (NSAID) will tackle inflammation as well as pain. However these will not slow down the progress of rheumatoid arthritis and, as with any drugs there will be side-effects. If an NSAID is insufficient then corticosteroids will also help reduce pain, stiffness and swelling but only on a short-term basis as their long-term use can lead to serious side-effects. To actually slow down or even halt the progress of the condition the most effective drug treatment currently is to use a disease modifying anti rheumatic drug (DMARD). This group of drugs include methotrexate, leflunomide, hydroxychloroquine and sulphasalazine. When integrated into an existing treatment framework this can help create a stable clinical platform on which the whole multidisciplinary support package can stand and can be effective. No matter how good a support package is, if the patient continues to suffer pain, swelling and mobility constraints they are unlikely to get the best value from that package.

Although, as healthcare challenges go, rheumatoid arthritis and psoriatic arthritis are not common or numerous occurrences, they have the potential to ruin lives, so that a decent treatment framework, well delivered by a dedicated GP and an appropriate multidisciplinary team can make all the difference to a patient, and their family.

enhancing patient independence

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

References: 1 NICE Clinical Guideline, ‘Rheumatoid arthritis in adults’ http://www.nice.org.uk/nicemedia/live/12131/43330/43330.pdf, page 4.

1

2

RCGP News July 2010 http://www.rcgp.org.uk/PDF/RCGP_News_July10.pdf, page 6

3

Rheumatoid Arthritis http://www.patient.co.uk/showdoc/40001157/

4

‘Living with Arthritis Checklist’ http://arthritis.about.com/od/inthehomedailyliving/a/living_with_arthritis_checklist.htm

5

What is good rheumatoid arthritis care? http://www.nhs.uk/Conditions/Rheumatoid-arthritis/Pages/Treatment.aspx

6

Disease-modifying anti-rheumatic drugs (DMARDs) http://www.nhs.uk/Conditions/Rheumatoid-arthritis/Pages/Treatment.aspx

7

Leading the way to shared decision making

http://www.health.org.uk/publications/leading-the-way-to-shared-decision-making/ 8

Rheumatoid Arthritis http://www.patient.co.uk/showdoc/40001157/

9

What is good rheumatoid arthritis care? http://www.nhs.uk/Conditions/Rheumatoid-arthritis/Pages/Treatment.aspx

10

NICE Clinical Guideline 79 – Rheumatoid arthritis http://www.nice.org.uk/nicemedia/pdf/CG79NICEGuideline.pdf page 6

11

RCGP News July 2010 http://www.rcgp.org.uk/PDF/RCGP_News_July10.pdf, page 6

12

RCGP News July 2010 http://www.rcgp.org.uk/PDF/RCGP_News_July10.pdf, page 6

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SPECIAL REPORT: RHEUMATOID ARTHRITIS AND SEVERE PSORIASIS TREATMENT

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