Conversations in rheumatoid arthritis (ra) therapy

Conversations in Rheumatoid Arthritis: Involving Your Patients in Therapy Discussions © Thinkstock by Getty Images

Dear Colleague: As we consider how to approach our decision-making in selecting a biologic disease-modifying antirheumatic drug (DMARD), specifically the tumor necrosis factor antagonists (anti-TNFs), we are confronted with many questions: • Which therapy will work best for each individual patient?

• How does maintaining a dialogue with our patients help us select the most appropriate treatment option?

• What are our patients’ fears and concerns, including efficacy and safety issues, for each therapy?

• How can we as clinicians better address these concerns and educate patients on their disease state and treatments?

It is crucial to initiate the conversation with our patients to educate them and individualize treatment. We need to encourage them to feel comfortable enough to express their feelings and ask questions. Additionally, we need to have further discussions to adequately monitor selected therapies, including by assessing treatment response, disease progression, and adverse events.

Sincerely,

Ellen M. Field, MD, FACR FACULTY REVIEWER Ellen M. Field, MD, FACR Rheumatologist Lehigh Valley, Pennsylvania

W

hen clinicians decide the most appropriate therapy for their patients with rheumatoid arthritis (RA), efficacy, safety and the needs of each individual patient need to be taken into account. Guidelines are meant to provide a starting point for therapeutic decision-making. Initially, treatment options should be based on goals of therapy, whether the patient has early or established RA, the level of disease activity, prognostic features, comorbidities, medication history, tolerability of previous RA medications, and safety considerations of each therapy. However, when reviewing the risks and benefits of the therapeutic choices, it is important to individualize treatment and discussion.1 Both the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) recommend customizing treatment to meet individual needs.1,2 In order to gain enough patient information to meet these needs, two-way communication between the healthcare provider and the patient is required.2 PRESENTING THERAPEUTIC OPTIONS Before explaining treatment options, the patient’s goals of therapy should be discussed.

The ACR guidelines do not recommend a specific goal for all patients; ideally, the goal of therapy for all patients should be RA remission.

However, low disease activity is an acceptable goal based on the individual patient.1 Low disease activity can provide relief from joint pain, stiffness, and swelling, and may be obtained by using a biologic disease-modifying antirheumatic drug (DMARD).3 If considering treatment with a biologic DMARD, and specifically 1 of the 6 tumor necrosis factor antagonists (anti-TNFs), patients

need to be screened for tuberculosis and hepatitis B, as treatments can exacerbate these conditions.4 Anti-TNF medications should be used with caution in patients with untreated chronic hepatitis B infection and congestive heart failure (NewYork Heart Association Class III or IV with an ejection fraction ≤50%).1 When presenting therapeutic options, patients should be provided with a sufficient understanding of their disease. Be sure that they are aware of the nature of the disease state and why they are being prescribed an anti-TNF agent or combination of agents. If patients do not understand the significance of their disease and its progressive nature, they may not feel the need to seek early treatment, which slows the disease process, prevents further joint damage, and provides symptom relief.3 ONCE A CHOICE IS MADE When speaking to your patients about their prescribed therapy, be sure to include the following information: • Treatment goals, including those related to their RA symptoms • How biological therapy will help them reach these goals • Common adverse effects and safet y considerations • Potential interactions with concomitant medications • Required routine monitoring for liver abnormalities, tuberculosis, hepatitis B, other infections, and overall treatment tolerability.

There are additional considerations and counseling points based on the administration technique you are considering for your patient ( Table 1).

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TABLE 1. Considerations based on treatment modality.

Self-Injection • When selecting the self-injection method, consider whether the patient or caregiver has adequate vision and manual dexterity, a refrigerator to store the medication, and a sharps container to dispose of it.

• The first injection is typically in the rheumatologist’s office, with instruction by a nurse or physician. Patients for whom self-injection of anti-TNF medication is prescribed should spend time with a clinician to be sure they are confident in their self-care.

• Patients need to learn about the injection sites in the thigh and abdomen, the importance of rotating sites, and proper injection techniques. Ideally, patients should be able to test their injection skills after watching a physician or nurse demonstrate the procedure.

• Although the treatment usually comes in a prefilled injection device, if the self-injectable requires diluting the drug, the clinician should be sure that the patient is capable of doing so before being sent home to self-inject for the first time.

• Patients or caregivers will be responsible for not only administering the injection at home, but also for storing injection devices in the fridge and safely disposing of them after use. The patient should follow community guidelines for how to dispose of the sharps container once it is full. Patients will also need to know how to safely store their medications while travelling.

• Injection devices vary for each medication. It is critical for the patient to understand how to use a specific injection device for the medication prescribed, even if the patient is comfortable with self-injection or has had previous injection experience with other devices.

• A thorough review of the patient guide, which includes the dosing schedule, storage, and disposal of the syringes, is essential.

Infusion • Patients who have been prescribed infusion therapy should be given a tentative schedule of their appointments, which may be more frequent initially, depending on their individual regimen.

• Before each infusion, weight and vital signs will be assessed.

• Patients will need to know why it is important that they adhere to a certain schedule.

• They should be able to travel to appointments and be aware of the time it will take to complete the infusion.

If patients have not received vaccinations, such as pneumococcal, influenza intramuscular, hepatitis B, meningococcal, and human papillomavirus vaccines, they should do so before starting treatment. During treatment with anti-TNF medications, patients should not receive live, attenuated vaccines due to patients’ immunosuppression.1 Clinicians should set appropriate efficacy expectations regarding treatment. Some patients may experience a response as early as 2 weeks into treatment, but most patients will likely need more time, up to 3 months.4 ONGOING SUPPORT AND MONITORING Upon initiation of anti-TNF therapy, be sure to communicate the signs of danger that should alert the patient or caregiver to seek immediate medical assistance: anaphylaxis, severe pain, rash, or breathing difficulty.1

They should be familiar with more common side effects as well, including injection-site reactions.4 It is essential to schedule regular follow-up visits and phone calls to assure the patient that their healthcare team will monitor for efficacy and any serious adverse effects, such as infections, tuberculosis, and liver abnormalities.1 At follow-up visits, be sure to remind patients that their immune systems are vulnerable to bacterial, fungal, and viral infections. Patients taking anti-TNF drugs should also be aware that they are susceptible to lymphoma and skin cancers.4 Inform patients contemplating pregnancy as well as breastfeeding of the need to discontinue anti-TNF therapy. They should know that pregnancy may have a temporary salutary effect on their disease, but flare-ups can re-emerge postpartum.5

Discuss with your patients how you will measure success and how often they will need to return to the office for followup visits and lab tests. The Rheumatoid Arthritis Disease Activity Index is one such measure that can determine whether the selected therapy or combination of therapies is effective.6 In addition to using validated efficacy scales, it is helpful to develop mutually agreed-upon goals with your patients and ask candid follow-up questions as to whether they are progressing as well as they thought they would.7 By providing patients—and their families—with an understanding of the RA disease state, therapeutic options, and coping mechanisms, clinicians can foster a better working relationship with them as the disease progresses. Educating patients about both pharmacological and nonpharmacological treatments allows them to better manage their disease, resulting in improved clinical progress.8 Maintaining a dialogue with your patients with RA is fundamental to therapeutic success.7 REFERENCES 1. Singh JA, Furst DE, Bharat A, et al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(5): 625-639.

2. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73(3):492-509.

3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on health: rheumatoid arthritis. http://www.niams.nih.gov/Health_Info/Rheumatic_Disease/default.asp. Accessed January 27, 2014.

4. American College of Rheumatology. Anti-tumor necrosis factor fact sheet. http://www.rheumatology.org/Practice/Clinical/Patients/Medications/Anti-TNF/. Accessed January 24, 2014.

5. American College of Rheumatology. Pregnancy and rheumatic disease. http://www.rheumatology.org/ Practice/Clinical/Patients/Diseases_And_Conditions/ Pregnancy_and_Rheumatic_Disease/. Accessed January 24, 2014.

6. Scarpato S, Antivalle M, Favalli EG, et al. Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis: results from a questionnaire survey (RIVIERA study). Rheumatology (Oxford). 2010;49(2):289-294.

7. Ryan S, Hassell A, Dawes P, Kendall S. Control perceptions in patients with rheumatoid arthritis: the impact of the medical consultation. Rheumatology (Oxford).

2003;42(1):135-140.

8. da Mota LM, Cruz BA, Brenol CV, et al. 2012 Brazilian Society of Rheumatology consensus for the treatment of rheumatoid arthritis. Rev Bras Reumatol. 2012;52(2): 135-174.

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Rheumatoid Arthritis Discussion Guide for Use with Your Doctor After reviewing your medical history, test results, and the safety and efficacy of various therapeutic options, your doctor has determined that a biologic agent is the appropriate treatment for your rheumatoid arthritis. In order to ensure this treatment is effective, strong communication between you and your doctor is essential.1 Biologic agents are medications that help decrease inflammation and structural damage to the joints by interrupting the cascade of events that cause inflammation.The goals of your treatment include relieving pain, decreasing inflammation, and slowing down or stopping joint damage.1 Throughout treatment, it is important for you to regularly visit your doctor for routine monitoring and ongoing care.

This will help your doctor assess the effectiveness of your treatment, including negative effects of medications that could necessitate the modification of your treatment plan.1 Potential side effects of biological therapies include redness, swelling, itching, bruising, or pain at the site of administration. Other possible side effects include sinus infection, headache, nausea, or diarrhea. Rare but serious side effects that can occur include serious infections or cancer.2 Self-Injection

Infusion

You inject yourself after proper training by a doctor or nurse

Infusion is prepared and given by a doctor, nurse, or trained healthcare professional

You fill the prescription and store medication in refrigerator

Your doctor prescribes and a healthcare professional stores your medication until the time of your infusion

Where

Treatment is usually self-injected at home, after you receive proper training

Treatment is given at your doctor’s office or infusion center

How

Injected under the skin of your abdomen or thigh

Infusion through a needle placed in a vein, usually in your arm

Frequency varies (once a week or less often), depending on the medication used

As often as once a month or less often, depending on the medication used

Prefilled injection device with fixed amount of medication for each dose

Your blood pressure, heart rate, temperature, and weight will be checked before each treatment

Dispose of the injection device in a sharps container and follow your community guidelines on how to dispose of the container once it is full

Amount of medication for each dose based on your weight

Who

Taken with methotrexate, as directed

Taken with methotrexate, depending on medication, as directed Requirements

Training Manual dexterity n Good vision n Refrigerator to store medication before use n Container to safely dispose of used syringe n

n

Ability to travel to appointments

n

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The following questions are meant to help you and your doctor decide whether infusion at your doctor’s office or clinic, or self-injection at home, is better suited to you and your individual needs.

How often will I need treatment? n

n

Infusion treatment can be administered as often as once a month or less often, depending upon the medication.

Infusion time varies by medication.

Self-injection treatment can be done by you or a caregiver, after training from your doctor or nurse, as often as once a week or less often, depending upon the medication.

Where will my treatment take place? n

Infusion is prepared and given by a healthcare professional at a doctor’s office or infusion center.

n

Self-injection is prepared and given by you or your caregiver in your home, requiring you to keep all the

medication and supplies on hand.

How will my treatment be administered? n

Infusion is prepared and given by a healthcare professional through a needle placed in a vein, usually in your arm.

n

For self-injection treatment, you will prepare and give yourself an injection just below the surface of your skin in

your abdomen or thigh, after training by your doctor or nurse.

Support and safety n

Do you have any physical limitations that might interfere with your ability to self-inject?

n

Do you have support at home to help you if you need it?

n

Do you have a good place to safely store your medication in your refrigerator, out of the reach of children?

n

Do you have a safe place to store a sharps disposal container with used syringes, out of the reach of children

and pets?

For full details on what to tell your doctor, both before you begin treatment and after treatment has begun, please see the Medication Guide for the product that your doctor has prescribed for you. The U.S. Food and Drug Administration requires that medication guides be provided with certain prescribed drugs and biologic products.

REFERENCES 1. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on health: rheumatoid arthritis. http://www.niams.nih.gov/Health_Info/ Rheumatic_Disease/default.asp. Accessed January 21, 2014.

2. Agency for Healthcare Quality and Research. Medicines for rheumatoid arthritis: a review of the research for adults. AHRQ Pub. No. 12(13)-EHC025-A. November 2012.

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