29 minute read
What is the evidence base to support the nurse specialist when counselling adult patients considering a systemic treatment for atopic eczema?
Laura Crosby
This article looks at the rationale and evidence which can help nurse specialists when counselling patients who are considering taking systemic treatments, such as baricitinib and dupilumab for the treatment of atopic eczema. The article looks at how information is provided, the need for patients to understand risks and benefits, and the importance of giving the patient choice and control over their treatment.
Crosby L. What is the evidence base to support the nurse specialist when counselling adult patients considering a systemic treatment for atopic eczema? Dermatological Nursing 2021. 20(2):15-19
Atopic eczema
Atopic eczema, or atopic dermatitis, is a chronic inflammatory skin condition.1 It is believed that external environmental irritants, such as the weather and soap, alongside the body’s genetically programmed immune response, combine to cause breakdown in the skin barrier and a cycle of increased immune response.2 This can lead to cracked, itchy, dry, and inflamed skin which presents further opportunities for irritants to breach the skin barrier.3
Laura Crosby is a Clinical Nurse Specialist in Medical Dermatology at University Hospital Bristol and Weston NHS Foundation Trust.
Developments in treatment options
Dupilumab was licensed for use in the UK in 20184 and baricitinib became the second advanced therapy with approval from NICE in March 2021.5 Several other advanced therapies are currently in the process of seeking NICE approval for the treatment of adult atopic dermatitis.
The rapid developments in treatment options, in a previously difficult to treat condition, results in additional requirements to counsel and monitor patients prior to and during treatment. The nurse specialist has a unique role supporting the patient on their treatment pathway by tailoring information delivery to meet their needs.7
Commencing any planned treatment for atopic eczema should be a shared decision whenever possible Engaging patients in shared decision making
Commencing any planned treatment for atopic eczema should be a shared decision whenever possible, as it is believed that involving patients in their care and treatment plans improves patient compliance.8 This means that patients should be involved in a thorough discussion about their proposed treatment, with a rationale for the treatment recommendation and a risk-benefit analysis.9 It is thought that this shared decision making is particularly important in relation to medication, as the patient will need to accept, understand and administer treatment.10 The nurse specialist can play an important role in this discussion by building trust with patients and ensuring they have a realistic understanding of the risks and benefits of treatment and should, therefore, ensure this is carried out in a timely and effective manner.9 There is a selection of literature8-11 which provides advice on what information
should be included in these discussions. Maguire and Pitceathly8 include six points. These are all very patient focused and include: establishing patients’ understanding of their diagnosis, including the physical and emotional effects it has on them and their family; presenting information in an accessible and individualised way to the patient and checking their understanding of this information; and understanding the patients’ main concerns about the information being discussed.
Coulter10 gives a much shorter list to guide discussion. This simply suggests discussing the benefits, risks, alternatives to suggested treatment and a discussion around the option of doing nothing. Oxman et al.11 give a lengthier checklist suggesting the clinician goes into detail about all aspects of the proposed treatment including absolute risk versus relative risk, as well as certainty of evidence.
For example, taking figures from Simpson et al.1 the absolute risk of developing conjunctivitis in adult atopic eczema patients taking dupilumab would be 13%. Relative risk would give a percentage increase in chance of developing conjunctivitis on dupilumab compared to those adults with atopic dermatitis who don’t take dupilumab. If 8% of adults with moderate to severe atopic dermatitis will develop conjunctivitis and this figure goes up to 13% for those on dupilumab, this could be viewed as a relative increase in risk of 62.5%. Some patients may view this as a high risk, but the reality is that they still only have a 13% chance of developing conjunctivitis on dupilumab.
The relative risk figure can be misleading, so Oxman et al.11 advise using absolute risk to avoid such confusion. Whilst more thorough lists may be valid, they may not be easy to follow during a verbal conversation with a patient. A simpler four step approach10 may be easier to remember and use during a face-to-face discussion. However, being familiar with the more detailed checklist would help to ensure the information discussed is accurate and not misleading. The British Association of Dermatologists (BAD) provides patient information leaflets which cover much of the information that we need to make available to patients. However, simply providing a leaflet does not offer patients the opportunity to discuss concerns at a deeper level, and it does not ensure patients have received the information in a way they can access and understand. It is a useful starting point for some patients as it provides a basic background for further discussion but it should not be used in place of counselling.
Figure 1.
Atopic dermatitis treament pathway. (Taken from NICE6)
Figure 2.
Conjunctivitis cases in adult patients with moderate to severe atopic eczema.
Not taking Dupilumab Taking Dupilumab
Understanding diagnosis and treatment options
Some of the literature suggests starting discussions by ensuring patients understand their diagnosis and treatment options.8,11 It is therefore necessary to ensure that patients understand the role of the skin and immune system in atopic eczema. When discussing treatment options it may be appropriate to explain the different ways in which these work.
Patient information leaflets such as those produced by the BAD can be useful tools to begin these discussions. However, the disease process and the mode of action of these treatments can be complicated, so there would need to be careful consideration of the way this information is presented to ensure patients are able to understand it. Siegel12 highlights the importance of presenting information using multiple methods. This may mean resources such as videos, diagrams (such as the graphic to represent conjunctivitis prevalence, above) and leaflets would be beneficial in supporting the discussion around disease and treatment methods.
Patient information videos such as those produced for dupilumab13 may be useful for communicating information with patients, provided caution is taken due to the source. During this initial discussion it may also be worth introducing the method of administration as some patients may not be willing or able to tolerate injections on a regular basis, or may prefer infrequent injections over daily tablets, and this may impact on their decision to commence treatment.10 The nurse specialist may also choose to use training devices that simulate the administration of injectable treatments to demonstrate the method to patients. This may provide the patient with a practical and hands-on demonstration, which some patients could find useful.
Benefits and risks of treatment
The checklists around patient risk discussions often include the benefits of a particular treatment.10,11 Using terminology that is appropriate for the individual patient is important to ensure the data is presented in a way that each patient can understand but that also provides enough information.12 Treatment being provided following the NICE Eczema care pathway will be evidence based and this evidence can be found by looking at the NICE Technology Appraisal Guidance (TAG) for the specific medication. For example, NICE,5 which looks at the benefits and research limitations of baricitinib. This research may not be in a format that is accessible to the entire patient group, meaning the nurse specialist would need to be able to read and interpret this information when discussing with a patient. The BAD14 has published a decision-making aid for biologic treatment of psoriasis which provides a more visual way of sharing similar information, and it may be useful to have a similar document for the treatment of atopic eczema.14
It is important to understand the patient’s main treatment goal8 to ensure consideration of this is discussed. Oxman et al.11 mention the importance of being consistent with terminology so it may be helpful to use the same tools throughout patient assessment, treatment benefits, and research and efficacy checks. NICE15 guidance refers to Eczema Area Severity Index (EASI)16 and Dermatology Life Quality Index (DLQI)17 scores so it may be that when discussing the benefits of a treatment it is useful to discuss research findings using these validated tools. However, this may not be appropriate if the patient has a goal which is not measured by the EASI or DLQI scores. Patients may be satisfied simply to know that the evidence from trials supports the use of a particular treatment, but it is important that the information is available if they wish to discuss this in greater detail. OsMedendorp et al9 highlights the need for this information to be presented in a way that meets the individual needs of the patient. Furthermore, Trevena et al.18 put forward evidence that patients understand risk better when it is presented in a variety of formats, including visual representations. It is therefore necessary to ensure that discussions around benefits are focused around the patient’s own goals and that the information is presented in an appropriate format for each individual.
It may be pertinent to discuss some of the limitations of the evidence, such as the lack of data around the longerterm benefits and unknown risks of newer treatments, or to discuss the inclusion criteria for the trials, which may differ from real world population. The nurse needs to differentiate ‘lack of evidence’ from ‘lack of effect’11 and it is important to ensure that the patient understands this concept.
Another point that may be significant when discussing trial data is the inclusion and exclusion criteria. If a particular patient group is not adequately represented in the trial data then it may be appropriate to discuss this with the patient. An example of this would be the small numbers of certain ethnic groups enrolled in the three main dupilumab trials. This lack of evidence is discussed in the NICE4 guidance, which suggests that the cytokine pathways differ between ethnic groups. Whilst IL-4 and IL-13 are significant in most populations, the Asian population may have greater involvement of IL-17 and therefore the data may not be relevant in this population. It might be relevant to note that exclusion criteria are not discussed in this trial data and therefore we do not have figures relating to patients who may have been excluded. It may also be worth mentioning to patients the difference between trial outcomes and real world data. This may be useful according to some of the more detailed discussion checklists, which mention certainty and misleading evidence.11 However, Maguire and Pitceathly8 comment on the importance of presenting information in a format that patients can understand. It is unlikely that patients would need all the information on the limitations of research, but as a specialist nurse it would be necessary to distill out any relevant information and find an approachable way to present this to patients.
It is also important to discuss the potential risks and side effects. It may be appropriate to consider the likelihood and severity separately, since these may have an impact on the patient’s decision to commence treatment.11 A common low severity side effect may be one that the patient is willing to accept whilst a rare but very serious side effect may not.
Reflecting on how this information can be tailored to each individual may ensure a more appropriate and patient-centred approach. This, if misunderstood, could unduly influence a patient’s decision and it should therefore be a priority to ensure this is managed in an individualised way.12 Siegel12 and Trevena et al18 recommend the use of pictorial or other visual representations of risk, such as Figure 2. This may include patient information leaflets from organisations such as BAD and drug manufacturers. Whilst these support materials may go some way to accommodating individual preference, they may not provide enough variety in the way information is presented. Therefore, it is essential that the nurse specialist finds an appropriate format in which to present this information to each individual patient.
Alternative options for treatment
When discussing a proposed treatment with patients, Coulter10 and OsMedendorp et al.9 advocate inclusion of discussion of alternative treatments and the option to do nothing. The data around the placebo group’s rate of infections in clinical trials could play a part in this discussion. The trials don’t specifically look at the risks associated with not commencing a treatment, but they provide a possible indication of increased risk. Alongside an understanding of the role of the skin barrier in preventing infection, it may be possible to link poorly controlled disease with a greater risk of skin infection.
Alternative options for patients should be discussed, even though the present treatment options for atopic eczema are likely to have been explored prior to commencing a higher-cost drug due to the NICE and Scottish Medicine Consortium4,19 criteria for access. It is, however, possible for patients to reconsider options that were previously not considered, ruled out, or provided a partial response.
Patients may be satisfied simply to know that the evidence from trials supports the use of a particular treatment Counselling patients with different communication needs
It is important to remember that not all patients will be able to engage with shared decision-making using written or spoken English language alone. There are many groups of people who will require additional or alternative methods of communication. Some of these may be quite straightforward, such as providing information leaflets in a number of languages and using interpreters to support discussions. NHS England20 highlights the need to identify and document communication or information needs at the first contact. This document goes on to list some prompts or questions that could enable the specialist nurse to identify any additional needs.
Patients who are not able to read information leaflets due to impaired vision may benefit from large print, Braille, or audio leaflets.
Patients with hearing loss may use a number of methods to support their communication, including hearing loops, lip-reading and sign language. As such, it would be important to establish what method or methods of communication each patient uses and to ensure these are accommodated and documented in every discussion. Patients with a learning disability may also have additional communication needs. Depending on the disability it may be necessary to carry out consultations and counselling with the support of a patient advocate. Additionally, it may be useful to use simple pictures to assist in discussions.21 All additional or alternative communication methods should be clearly documented in patient records as part of the consultation record.
Conclusion
The nurse specialist should ensure that information is shared in an individualised way when counselling a patient. They also have a role as patient advocate.7 Often, they are the point of contact for a patient throughout their treatment and in a privileged position to build trust with the patient.7 For this reason, the nurse specialist is in a good position to form a close therapeutic relationship with patients and can therefore tailor discussions around treatment to suit the individual through use of clinical knowledge, understanding and suitable presentation resources.
In conclusion, considering diagnosis, treatment options, risks, benefits, and alternative treatments could be significant in the effectiveness of patient counselling prior to treatment with a systemic therapy. However, the method of sharing this information is crucial if the nurse specialist is to successfully enable the patient to fully understand the treatment they are being offered. DN
References
1. Simpson EL, Bieber T, Guttman-Yassky LA, Beck A, Blauvelt MJ, Cork JI, Yancpoulos GD. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. The New England Journal of Medicine 2016. 375(24):2335-2348 2. Stanway A. Atopic Dermatitis. DermNet NZ 2004. Available at: https://dermnetnz.org/topics/ atopic-dermatitis/ [last accessed May 2021] 3. British Association of Dermatologists. Atopic Eczema 2020. Available at: https://www.bad.org.uk/shared/get-file. ashx?id=69&itemtype=document [last accessed May 2021] 4. NICE National Institute for Health and Care Excellence. Dupilumab for treating moderate to severe atopic dermatitis 2018. Available at: https:// www.nice.org.uk/guidance/ta534 [last accessed May 2021] 5. NICE National Institute for Health and Care Excellence. Baricitinib for treating moderate to severe atopic dermatitis 2021: Recommendations. Available at: https://www.nice.org.uk/guidance/ ta681/chapter/1-Recommendations [last accessed May 2021] 6. NICE National Institute for Health and Care Excellence (2020) Baricitinib for treating moderate to severe atopic dermatitis: Slides for public. Available at: https://www.nice.org.uk/guidance/ ta681/documents/1l [last accessed May 2021] 7. Oliver SM. The Role of the Clinical Nurse Specialist in the Assessment and Management of Biologic Therapies. Musckuloskeletal care 2011. 9:54-62 8. Maguire P, Pitceathly C. Key communication skill and how to acquire them. BMJ 2002. 325. 697-700 9. Os-Medendorp H, Deprez E, Maes N, Ryan S, Jackson K, Winders T et al. The role of the nurse in the care and management of patients with atopic dermatitis. BMC Nursing 2020. 19(102). Available at: https://doi.org/10.1186/s12912-02000494-y [last accessed May 2021] 10 Coulter A. How to provide patients with the right information to make informed decisions. The Pharmaceutical Journal 2018. 301(7915) DOI:10.1211/PJ.2018.20204936 11. Oxman AD, Glenton C, Flottorp S, Lewis S, Rosenbaum S, Fretheim A. Development of a checklist for people communicating evidencebased information about the effects of healthcare interventions: a mixed methods study. BMJ Open 2020. 10 doi:10.1136/bmjopen-2019-036348. Available at: https://bmjopen.bmj.com/ content/10/7/e036348 [last accessed May 2021] 12. Siegel CA. Review article: explaining risks of inflammatory bowel disease therapy to patients. Alimentary Pharmacology and Therapeutics 2011. 33:23-32 13. Dupixent 2020. Available at: https://www. dupixent.com/atopicdermatitis/about-dupixent/ how-dupixent-works [last accessed May 2021] 14. British Association of Dermatologists (BAD) Decision Aid for Biological Therapy for Psoriasis. Available at: https://www.bad.org.uk/shared/getfile.ashx?id=6904&itemtype=d [last accessed May 2021] 15. NICE. Treating Eczema in people over 12. Available at: https://pathways.nice.org.uk/ pathways/eczema#path=view%3A/pathways/ eczema/treating-eczema-in-people-over-12. xml&content=view-node%3Anodes-adult-withatopic-eczema-or-hand-eczema [last accessed May 2021] 16. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Experimental Dermatology 2001. 10(1):11-18 17. Finlay AY, Kahn GK. Dermatology Life Quality Index 1992. Available at: https://www. cardiff.ac.uk/medicine/resources/quality-of-lifequestionnaires/dermatology-life-quality-index [last accessed May 2021] 18. Trevena LJ, Zikmund-Fisher BJ, Edwards A, Gaissmaier W, Galesic M, Han PKJ et al. Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers. BMC Medical Informatics and Decision Making 2013. 13 (Suppl 2). Available at: http://www.biomedcentral. com/1472-6947/13/S2/S7 [last accessed May 2021] 19. Scottish Medicines Consortium. Dupilumab 300mg solution for injection in pre-filled syringe (Dupixent) 2018. Available at: https://www. scottishmedicines.org.uk/medicines-advice/ dupilumab-dupixent-fullsubmission-smc2011/ [last accessed May 2021] 20. NHS England. Accessible Information Standard 2016. Available at: https://www.england. nhs.uk/wp-content/uploads/2016/04/Identifyinginformation-and-communication-needs.pdf [last accessed May 2021] 21. University Hospital Southampton (ND) The Hospital Communication Book. Available at: https://www.uhs.nhs.uk/Media/SUHTInternet/ PatientsAndVisitors/Learningdisabilities/HospitalCommunication-Book-new.pdf [last accessed May 2021].
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Why write for Dermatological Nursing?
Dermatological Nursing is a quarterly, peer-reviewed publication that aims to provide cutting-edge articles on the treatment and management of dermatological conditions and the care of patients with skin problems. While the focus is on dermatological nursing, the information included will be relevant to other healthcare professionals. Writing for Dermatological Nursing can be a useful way to help develop and crystallise ideas about a specific topic, and may encourage exploration of an area in greater depth and lead to further understanding. Once you have made the decision to write for Dermatological Nursing, please contact the Managing Editor to ensure that what you are planning to write has not already been commissioned, and that it is appropriate for the readership. The article should be unpublished and have not been submitted for publication elsewhere.
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SHARED RESULTS SHARED RELIEF
DUPIXENT (dupilumab) is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged 12 years or older and for severe AD in children aged 6–11 years, who are candidates for systemic therapy1
First and only targeted immunomodulator
to specifically inhibit IL-4 and IL-13
signalling, key drivers of persistent underlying Type 2 inflammation1,2 Improvements with DUPIXENT compared to placebo at 16 weeks in all populations and now also in children aged 6–11 years1,3–8 – Lesion extent and severity1,3–7 – Pruritus intensity1,3–7 – Quality of life measures1,3–8 Safety profile investigated in patients as young as 6 years old, consistent with safety profile of adolescents at 1 year and adults at 3 years1 – Does not require routine laboratory monitoring1
Dupixent (dupilumab) solution for injection in a pre-filled syringe or pen (Atopic Dermatitis) Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentations: Dupixent 200 mg solution for injection in a pre- filled syringe or pen, containing 200 mg of dupilumab in 1.14 ml solution (175 mg/ml) or Dupixent 300 mg solution for injection in a pre-filled syringe or pen, containing 300 mg of dupilumab in 2 ml solution (150 mg/ml). Indication: Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy. Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Dupixent should be administered as subcutaneous (SC) injection, into the thigh or abdomen, except for the 5 cm around the navel. The upper arm can be used if not selfadministered. Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Adults: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg given every other week (EOW). Adolescents (12-17 years) with body weight <60 kg: the recommended initial dose of Dupixent is 400 mg (two 200 mg SC injections), followed by 200 mg EOW. Adolescents (12-17 years) with body weight ≥60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg SC injections) followed by 300 mg EOW. Children 6 to 11 years of age with body weight 15 kg to <60 kg: the recommended initial dose of Dupixent is 300 mg on Day 1, followed by 300 mg on Day 15. Subsequent doses of 300 mg every 4 weeks (Q4W) starting 4 weeks after Day 15 dose. The dose may be increased to 200mg EOW in these patients based on physician’s assessment. Children 6 to 11 years of age with body weight ≥ 60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg EOW. Missed dose: If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. No or partial response: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. If Dupixent treatment interruption becomes necessary, patients can still be successfully re-treated. Proper training should be provided to patients and/or caregivers on the preparation and administration of Dupixent prior to use according to the Instructions for Use (IFU) section in the package leaflet. Special populations: Elderly patients (≥65 years): No dose adjustment recommended. Renal impairment: No dose adjustment in patients with mild or moderate renal impairment. Very limited data available in patients with severe renal impairment. Hepatic impairment: No data available. Paediatric patients <6 years: No data available. Method of administration: The dupilumab pre-filled pen is not intended for use in children below 12 years of age. For children 6 to 11 years of age with severe atopic dermatitis, the dupilumab pre- filled syringe is the presentation appropriate for administration to this population. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of Dupixent should be discontinued immediately and appropriate therapy initiated. Anaphylactic reactions and angioedema have occurred from minutes up to seven days post injection. Helminth infection: Patients with known helminth infection were excluded from the clinical trials. Dupixent may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling. Patients with pre-existing helminth infections should be treated before initiating Dupixent. If patients become infected while receiving treatment with Dupixent and do not respond to antihelminth treatment, treatment with Dupixent should be discontinued until infection resolves. Conjunctivitis and keratitis related events: Conjunctivitis and keratitis related events have been reported with dupilumab, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Patients should be advised to report new onset or worsening eye symptoms to their healthcare provider. Patients treated with Dupixent who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate. Comorbid asthma: Patients with comorbid asthma should not adjust or stop their asthma treatments without consultation with their physicians. Patients with comorbid asthma should be monitored carefully following discontinuation of Dupixent. Vaccinations: Live and live-attenuated vaccines should not be given concurrently with Dupixent as clinical safety and efficacy has not been established. It is recommended that patients should be brought up to date with live and live-attenuated immunisations in agreement with current immunisation guidelines prior to treatment with Dupixent. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. is essentially “sodiumfree”. Interactions: Patients receiving Dupixent may receive concurrent inactive or non-live vaccinations. One study evaluating the pharmacokinetic effects of Dupixent on CYP substrates did not indicate clinically relevant effects of Dupixent on CYP1A2, CYP3A, CYP2C19, CYP2D6 or CYP2C9 activity. Fertility, pregnancy and lactation: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are limited data from the use of Dupixent in pregnant women. Animal studies do not indicate harmful effects. Dupixent should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is unknown whether Dupixent is excreted in human milk or absorbed systemically after ingestion. A decision must be made whether to discontinue breast-feeding or to discontinue Dupixent therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Adverse effects: Adults: Very common (≥1/10): Injection site reactions. Common (≥1/100 to <1/10): Conjunctivitis, oral herpes, eosinophilia, headache, conjunctivitis allergic, eye pruritus, and blepharitis. Uncommon (≥ 1/1,000 to < 1/100): Keratitis, ulcerative keratitis. Very rare (< 1/10,000): Serum sickness/serum sickness-like reaction. Not Known: Anaphylactic reaction, angioedema, and athralgia Serious adverse reactions: eczema herpeticum, infections and immunogenicity have also been reported. Adolescents (12-17 years): The safety profile of Dupixent in adolescents aged 12- 17 years followed through week 16 study and through a long- term study was similar to the safety profile from studies in adults with atopic dermatitis. For full details please consult SmPC. Children (6-11 years): The long term safety profile of Dupixent observed in children and adolescents was consistent with that seen in adults with atopic dermatitis. For full details please consult SmPC. Legal Classification: POM. List Price UK: 4 week pack containing 2 x pre-filled syringes or pens: £1,264.89. IE: Price on application. Marketing Authorisation Holder: Sanofi-Aventis groupe – 54, rue La Boétie, 75008 Paris, France. Marketing Authorisation Numbers: 2 x 200 mg pre-filled syringe: EU/1/17/1229/010; 2 x 300 mg pre-filled syringe: EU/1/17/1229/006. 2 x 200 mg pre-filled pen: EU/1/17/1229/014; 2 x 300 mg prefilled pen: EU/1/17/1229/018. Further information is available from: UK: Medical Information, Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. uk- medicalinformation@sanofi.com. IE: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: December 2020.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to the Sanofi drug safety department on Tel: 0800 0902 314. Alternatively, send via email to UK-drugsafety@sanofi.com In Ireland: www.hpra.ie email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com
AD, atopic dermatitis; IL, interleukin. References: 1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: January 2021. 2. Gandhi NA, et al. Nature Rev Drug. Disc 2016;15:35–50. 3. Blauvelt A, et al. Lancet. 2017;389:2287–2303. 4. de Bruin-Weller M et al. Clinically Meaningful Responses in Moderate-to-Severe Atopic Dermatitis Patients Treated with Dupilumab (Presentation) presented at the 27th European Academy of Dermatology and Venereology Congress, Paris, France, September 12–16 2018. 5. Simpson EL, et al. JAMA Dermatol. 2020;156(1):44–56. 6. Paller AS, et al. Am J Clin Dermatol. 2020;21:119–131. 7. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293. 8. Sanofi Data on File. MAT-GB-2005006 (v1.0).
