Certolizumab pegol (Cimzia) for psoriatic arthritis second line

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1 Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes. The National Horizon Scanning Centre Research Programme is part of the National Institute for Health Research

2 Certolizumab pegol (Cimzia) for psoriatic arthritis second line Target group Psoriatic arthritis (PsA) second or third line. Background PsA is a chronic inflammatory joint disease associated with psoriasis of the skin or nails, which typically occurs before joint symptoms. PsA diagnosis tends to occur within 10 years of diagnosis with psoriasis 1 and leads to stiffness, pain, swelling and tenderness of the joints and surrounding ligaments and tendons. The most commonly affected areas include the small joints of the hands and feet, but it may also involve other larger joints such as hips, knees and spine 2. PsA has a chronic relapsing course, characterised by flares and remissions, which may be life-long 3. Although the cause of psoriasis and its associated arthritis is not fully understood, evidence suggests that it is a T-cell mediated disease, most likely auto-immune in origin, with a strong genetic component 4. Technology description Certolizumab pegol (Cimzia, CDP870) is a pegylated, Fab fragment humanised monoclonal antibody directed against tumour necrosis factor alpha (TNFα). Currently there are several TNFα inhibitors already marketed for the treatment of PsA. It is intended as a substitute therapy for the second or third line treatment of PsA, after failure of disease-modifying anti-rheumatic drugs (DMARDs). Certolizumab pegol is presented in a pre-filled syringe and administered subcutaneously (SC) at 400mg every 2 weeks for the first 4 weeks (3 doses) and 200mg every 2 weeks thereafter. An autoinjector device for the administration of certolizumab pegol is also being developed by the manufacturer and may be approved before the anticipated launch date. Certolizumab pegol is licensed in the USA and EU for the second line treatment of moderate-to-severe active rheumatoid arthritis, and in the USA and Switzerland for the treatment of Crohn s disease. Common reported side effects include: bacterial and viral infections, eosinophilic disorders, leukopenia, headaches, hypertension, hepatitis, rash and injection site reactions. Certolizumab pegol is also in phase III development for axial spondyloarthropathy, and phase II development for juvenile rheumatoid arthritis. Innovation and/or advantages If licensed, certolizumab pegol will offer an alternative therapy for this patient group. Developer UCB Pharma Ltd. Availability, launch or marketing dates, and licensing plans In phase III clinical trials. NHS or Government priority area None identified 2

3 Relevant guidance NICE technology appraisal in development. Psoriatic arthritis (moderate to severe) leflunomide. Suspended March NICE technology appraisal. Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (review) NICE technology appraisal. Certolizumab pegol for the treatment of rheumatoid arthritis NICE technology appraisal. Ustekinumab for the treatment of adults with moderate to severe psoriasis SIGN. Diagnosis and management of psoriasis and psoriatic arthritis in adults British Society of Rheumatology. Guideline for anti-tnf-a therapy in psoriatic arthritis Clinical need and burden of disease The prevalence of psoriasis in the general population is estimated at between 1.5-3% 1. The prevalence of inflammatory arthritis in people with psoriasis is estimated at 30% 1. An estimated 5-10% of people with psoriasis and 25-40% of people with PsA have severe arthritis with progressive joint lesions a. PsA has an equal gender distribution and characteristically develops in those aged years. PsA can significantly affect ability to work and to carry out daily tasks, which can have a substantial impact on quality of life 1. People with PsA have 60% higher risk of mortality 1 and their life expectancy is estimated to be reduced by approximately 3 years 9. In , there were 6,611 hospital admissions in England, accounting for 5,787 bed days 10. Existing comparators and treatments The clinical management of PsA aims to suppress joint, tendon and entheseal inflammation 3, and includes physical therapy, and a range of pharmacological treatments including 1,3 : Non-biologic therapies Analgesics. Corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). DMARDs including methotrexate (MTX), sulfasalazine, gold salts, anti-malarials and leflunomide. Usually administered within three months of diagnosis to stabilise joint function, either as monotherapy or in combination with biologic agents. Biologic therapies TNF-α inhibitors such as etanercept, infliximab and adalimumab. Efficacy and safety Trial NCT , PsA001; adults; certolizumab pegol vs placebo; phase III. Sponsor UCB Pharma Ltd. Status Ongoing. Source of Trial registry 11, manufacturer. information Location EU (inc UK), USA, Canada and other countries. Design Randomised, placebo-controlled. a Expert opinion. 3

4 Participants and schedule Follow-up Primary outcome Secondary outcome Expected completion date n=390; adults; PsA; active psoriatic skin lesions; 3 tender or swollen joints; failure of 1 or more DMARDs. Randomised to certolizumab pegol 200mg every 2 weeks or 400mg every 4 weeks; or placebo. Certolizumab pegol 200mg arm receive 400mg SC at trial entry, week 2, and week 4, then 200mg SC every 2 weeks from week Certolizumab pegol 400mg arm receive 400mg SC at trial entry, week 2 and week 4, then 400mg SC every 4 weeks from week Placebo group receive SC placebo injections every 2 weeks until week 24. Non responders at week 24 randomly assigned to certolizumab pegol 200mg or 400mg arms (dosing regimen as stated above). Active treatment period 156 weeks. American College of Rheumatology 20 (ACR20) response at week 12; modified Total Sharp Score (mtss) change from baseline at week 24. ACR20 at week 24; health assessment questionnaire - disability index (HAQ-DI) change from baseline at week 24; mtss at week 48; psoriasis area severity index (PASI75) response in subgroup of subjects with psoriasis involving 3% body surface area at week 24. June Estimated cost and cost impact The cost of certolizumab pegol for the treatment of PsA is not yet known. For the treatment of rheumatoid arthritis, certolizumab pegol costs for a 200mg pre-filled syringe. UCB Pharma currently has a patient access scheme (PAS) in place for this indication 12, which states that patients will receive the first 12 weeks of treatment drugcost free in accordance to NICE TA The following comparator anti-tnfα drugs are recommended for the treatment of PsA 13 : Drug Dose Period: 1 yr Adalimumab 40mg every 2 weeks. 9,295 (Humira) Etanercept (Enbrel) 50mg once weekly. 9,296 Claimed or potential impact speculative Patients Reduced mortality or increased length of survival Reduction in associated morbidity or Improved quality of life for patients and/or carers Quicker, earlier or more accurate diagnosis or identification of disease Other: None identified Services Increased use Service organisation Staff requirements Costs Decreased use Other: None identified Increased unit cost compared to alternative Increased costs: more patients coming for treatment Increased costs: capital investment needed New costs: Savings: Other: Uncertain unit cost compared to comparators (depending on dose regimen and patients) Other issues Clinical uncertainty or other research question identified: None identified 4

5 References 1 National Institute for Health and Clinical Excellence. Etanercept, infliximab and Adalimumab for the treatment of psoriatic arthritis (review). Technology appraisal TA199. London: NICE; August The Psoriasis Association. Psoriatic arthritis. May Kyle S, Chandler D, Griffiths CEM et al. Guideline for anti-tnf-a therapy in psoriatic arthritis. Rheumatology 2005;44: Griffiths CEM, Clark CM, Chalmers RJG et al. A systematic review of treatments for severe psoriasis. Health Technology Assessment 2000;4(40). NHS R&D HTA Programme ( 5 National Institute for Health and Clinical Excellence. Psoriatic arthritis (moderate to severe) leflunomide. Technology appraisal in development. Expected date of issue to be confirmed. 6 National Institute for Health and Clinical Excellence. Certolizumab pegol for the treatment of rheumatoid arthritis. Technology appraisal TA186. London: NICE; February National Institute for Health and Clinical Excellence. Ustekinumab for the treatment of adults with moderate to severe psoriasis. Technology appraisal TA180. London: NICE; September Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults. National clinical guideline 121. Edinbugh: SIGN; October Woolacott N, Bravo Vergel Y, Hawkins N et al. Etanercept and infliximab for the treatment of psoriatic arthritis: a systematic review and economic evaluation. Health Technology Assessment 2006;10: NHS. Hospital episode statistics. NHS England HES data ClinicalTrials.gov. Certolizumab pegol in subjects with adult onset active and progressive psoriatic arthritis. Accessed 8 August National Institute for Health and Clinical Excellence. List of technologies with approved Patient Access Schemes, recommended by NICE for use in the NHS. Accessed 8 August British Medical Association and Royal Pharmaceutical Society of Great Britain, British National Formulary. BMJ Group and RPS Publishing. London. March The National Institute for Health Research National Horizon Scanning Centre Research Programme is funded by the Department of Health. The views expressed in this publication are not necessarily those of the NHS, the NIHR or the Department of Health The National Horizon Scanning Centre, Department of Public Health and Epidemiology University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP, England Tel: +44 (0) Fax +44 (0)

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