Horizon Scanning Centre May Brodalumab for moderate to severe plaque psoriasis SUMMARY NIHR HSC ID: 5524

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1 Horizon Scanning Centre May 2014 Brodalumab for moderate to severe plaque psoriasis SUMMARY NIHR HSC ID: 5524 This briefing 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 or commissioning without additional information. Brodalumab is intended to be used for the treatment of moderate to severe plaque psoriasis in patients who have failed to respond to, have a contraindication to, or are intolerant to at least one systemic therapy. If licensed, it would offer an additional treatment option for patients who may not have responded to topical or systemic therapies, and offer an alternative to treatments with other biological agents. Brodalumab is a monoclonal antibody that targets and blocks the signalling pathway of interleukin receptors (IL-17A, IL-17F and IL-23). Brodalumab does not have Marketing Authorisation in the EU for any indication. Plaque psoriasis is the most common type of psoriasis, representing 90% of cases. The estimated UK prevalence of psoriasis is %, with 1.1% suffering with severe disease. It has a bimodal onset, with the first peak occurring in persons aged 16 to 22 years, and the second in persons aged 57 to 60 years. The prevalence of psoriasis in those younger than 10 years is estimated to be 0.55% and 1.4% in those aged between 10 and 19 years. The estimated prevalence of people currently eligible for biological therapy in England is 1.1% of those with psoriasis, equating to 7,100 people. Chronic plaque psoriasis is typified by itchy, well demarcated circular-to-oval bright red/pink elevated lesions (plaques) with overlying white or silvery scale, distributed symmetrically over extensor body surfaces and the scalp. Patients with psoriasis commonly experience a reduced overall quality of life and the adverse psychosocial issues associated with the condition can further worsen outcomes for patients with psoriasis. Current treatment options include topical ointments and emollients, phototherapy, systemic therapies (e.g. oral retinoids) and biological therapies. Brodalumab is currently in phase III clinical trials comparing its effect on the severity and extent of psoriasis against treatment with ustekinumab and placebo. This trial is expected to complete in This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health., University of Birmingham nihrhsc@contacts.bham.ac.uk Web:

2 TARGET GROUP Psoriasis: plaque form; moderate to severe patients who have failed to respond to, have a contraindication to, or are intolerant to at least one systemic therapy. TECHNOLOGY DESCRIPTION Brodalumab (AMG 827, KHK 4827) is a monoclonal antibody which targets the interleukin (IL) 17 receptor, blocking the signalling pathway of IL-17A, IL-17F and IL-25. Brodalumab is intended for the treatment of moderate to severe plaque psoriasis as an alternative to other biological agents, in patients who have not responded to, have a contraindication to, or are intolerant to at least one systemic therapy. Brodalumab is administered subcutaneously (SC), at a dose of 140mg or 210mg on day 1 of weeks 1 and 2, and then every other week. Brodalumab does not currently have Marketing Authorisation in the EU for any indication. Brodalumab is currently in phase III trial development for plaque psoriasis and psoriatic arthritis. It is also undergoing phase II trials for asthma. INNOVATION and/or ADVANTAGES If licensed, brodalumab will offer an additional treatment option for patients with plaque psoriasis who have not have responded to topical or systemic therapies, and offer an alternative to other biological agents. DEVELOPER Amgen. AVAILABILITY, LAUNCH OR MARKETING In phase III clinical trials. PATIENT GROUP BACKGROUND Psoriasis is an inflammatory skin condition typified by red, scaly lesions of the skin 1 which occur as a result of a rapid turnover of skin cells 2. The cause of psoriasis is not known; however genetics, the environment and an overactive immune system (in particular, T cells) are thought to play a part 3. Psoriasis typically follows a relapsing and remitting course, with flare ups occurring spontaneously 4. Contributors to flare ups include stress, infections, medications, sunlight, trauma, hormonal changes, smoking and alcohol 2. Plaque psoriasis is characterised by well-defined, sharply demarcated, erythematous plaques, which can be one centimetre to several centimetres in size. Plaques appear as dry, thin, silvery-white scales, and often smaller plaques merge forming larger plaques, particularly over the leg and trunk areas. Plaques may form across specific areas such as 2

3 the scalp, trunk, limbs, buttocks, elbows and knees, but can also manifest across the entire body causing pain and pruritus 5. Other forms of psoriasis include pustular psoriasis, nail psoriasis, guttate psoriasis and erythrodermic psoriasis 2. Patients with psoriasis often experience feelings of self-consciousness and embarrassment, and as a result, may suffer unemployment, social isolation and depression; all factors which contribute to a reduction in overall patient quality of life 6. The adverse psychosocial issues associated with the condition also contribute to worsening outcomes for patients with psoriasis a. NHS or GOVERNMENT PRIORITY AREA NHS England NHS Standard Contract for Specialised Dermatology Services (All ages). A12/S/a. CLINICAL NEED and BURDEN OF DISEASE Plaque psoriasis is the most common form of psoriasis representing approximately 80% to 90% of cases 1. The estimated UK prevalence of psoriasis is % 7,4, with 1.1% of people suffering severe disease 8. It has a bimodal onset, with the first peak occurring in persons aged 16 to 22 years, and the second in persons aged 57 to 60 years. The prevalence of psoriasis in those younger than 10 years is estimated to be 0.55%, and it is 1.4% of those aged between 10 and 19 years 7,9. Approximately 1 in 50 people will develop psoriasis at some stage 2. The estimated prevalence of people currently eligible for biological therapy in England is 1.1% of those with psoriasis, equating to 7,100 people 8. Females typically develop plaque psoriasis earlier than males, and patients with a positive family history for psoriasis also tend to have an earlier age of onset 7. Acute flares or relapses of plaque psoriasis may evolve into more severe disease, such as pustular or erythrodermic psoriasis 5. Psoriasis is also associated with a number of co-morbidities including psoriatic arthritis and cardiovascular disease a. The significant reduction in quality of life and psychosocial disability suffered by people with psoriasis underlies the need for prompt, effective treatment, and long-term disease control 10. In , there were 12,735 admissions for psoriasis (ICD-10 L40) in England, resulting in 16,016 bed-days and 13,315 finished consultant episodes 11. Thirty-one deaths from psoriasis were registered in England and Wales during 2012 (ICD-10 L40) 12. PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance NICE technology appraisal in development. Psoriasis (plaque, moderate to severe) - secukinumab [ID718]. Expected July NICE technology appraisal. Ustekinumab for the treatment of adults with moderate to severe psoriasis (TA180). September NICE technology appraisal. Adalimumab for the treatment of adults with psoriasis (TA146). June a Expert personal opinion. 3

4 NICE technology appraisal. Infliximab for the treatment of adults with psoriasis (TA134). January NICE technology appraisal. Etanercept and efalizumab for the treatment of adults with psoriasis (TA103). July NICE clinical guideline. Psoriasis: The assessment and management of psoriasis (CG153). October NICE quality standard. Psoriasis (QS40). August NICE interventional procedure guidance. Grenz rays therapy for inflammatory skin conditions (IPG236). November Other Guidance NHS Clinical Knowledge Summary. Psoriasis Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults (121) CURRENT TREATMENT OPTIONS Treatment options for psoriasis aim to reduce symptoms and improve patient quality of life. Topical treatments are usually offered as first line therapy, followed by phototherapy and/or systemic therapies as second line treatment, and biological therapies as third line treatment regimes. The majority of psoriasis cases are managed at the primary care level, though up to 60% of patients may require referral to a specialist 15. Current treatment options for plaque psoriasis include 16,17,18,19,20 : Topical (alone or in combination) Emollients. Corticosteroids: betamethasone dipropionate. Vitamin D analogues: calcipotriol, calcitriol, tacalcitol and tazarotene (with or without phototherapy). Tars (with or without phototherapy). Dithranol (with or without phototherapy). Retinoids: tazarotene. Salicyclic acid. Tacrolimus ointment (not licensed for this indication). Phototherapy Broad- or narrow-band UVB and psoralen and UVA combination (PUVA). Systemic therapies (for the treatment of patients with severe or refractory psoriasis) Oral retinoids: acitretin (with or without phototherapy). Hydroxycarbamide (not licensed for this indication). Ciclosporin. Methotrexate. Biological therapies (for the treatment of patients intolerant, contraindicated or refractory to other treatments) Drugs affecting the immune response: Adalimumab (TNF-α inhibitor). 4

5 Etanercept (TNF inhibitor). Infliximab (TNF-α inhibitor). Ustekinumab (IL-12 and IL-23 inhibitor). EFFICACY and SAFETY Trial NCT , , EUCTR ; brodalumab vs placebo; phase II. NCT , , EUCTR ; brodalumab; phase II extension. Sponsor Amgen. Amgen. Status Complete and published. Ongoing. Source of Publication 21,22, trial registry 23. Abstract 24, trial registry 25 information Location EU (not UK), USA, Canada and Australia. EU (not UK), USA, Canada and Australia. Design Randomised, placebo-controlled. Non-randomised. Participants n=198; aged 18 to 70 years; moderate to severe plaque psoriasis for at least 6 months; at least one previous phototherapy or systemic psoriasis therapy; affected BSA b 10% and PASI c 12 at screening and baseline. n=181; aged 18 and over; completed 16 week evaluation in study NCT without any serious adverse event or without any adverse event which could be detrimental to the subject if treatment continued. Schedule Follow-up Primary outcome/s Secondary outcome/s Key results Randomised to brodalumab, 70mg, 140mg or 210mg, SC on day 1 and weeks 1, 2, 4, 6, 8 and 10 or 280mg every 4 weeks (placebo on weeks 1, 2 and 6): or matching placebo, SC. Patients receive brodalumab 210mg or 140mg, SC on day 1, weeks 1 and 2 and then every two weeks. Active treatment period 10 weeks. Followup 16 to 22 weeks. Active treatment period and follow-up period up to 360 weeks. % improvement in PASI score. AEs; change in laboratory parameters and vital signs. Proportion of subjects with % PASI score Proportion of subjects with spga of 0 or improvements of 75, 50, 90 and 100; 1; percentage improvement in PASI BSA involvement; short-term safety score; proportion of subjects with % profile; pharmacokinetics; spga d of 0 or improvement in PASI score of 50, 75, and 100; BSA involvement. For brodalumab: 70mg (n=39), 140mg (n=39), 210mg (n=40), 280mg (n=42) and placebo (n=38), respectively (p values vs placebo unless specified otherwise): mean % improvement in PASI, 45.0%, 85.9%, 86.3%, 76.0% and 16.0% (all p<0.001); clinical response seen within 2 weeks and PASI improvement similar in patients regardless of prior biological therapy; %patients with 50%, 75%, 90% or 100% PASI score improvement, significantly higher in brodalumab groups vs placebo; mean improvement from baseline in BSA points, 9.5, 21.1, 22.1, 16.1 and 0.9 (all p<0.001 except 70mg brodalumab, p<0.01); mean % area All patients received brodalumab 210mg every 2 weeks (patients weighing <100kg given 140mg every 2 weeks). spga=0, 63% (n=175, 95% CI 55, 70) at week 12, 62% (95% CI 54, 70) at week 48 and 52% (95% CI 44, 60) at week 96; spga=0 or 1, 90% (n=175, 95% CI 85, 94) at week 12, 85% (95% CI 79, 90) at week 48 and 76% (95% CI 68, 82) at week 96. b Body surface area. c Psoriasis area and severity index. d Static physician s global assessment. 5

6 Adverse effects (AEs) Expected reporting date affected, 14.8, 3.8, 3.0, 5.2 and 22.5 (all p<0.001 except 70mg brodalumab, p<0.01); improvements in skin biomarkers in brodalumab group, not significantly different from placebo (sample of biopsies, n=20); DLQI e score, 6.5, 2.0, 2.0, 3.9 and 10.3 (p<0.05); SF- 36 f physical component, 51.9, 54.8, 52.1, 52.5 and 50.1; SF-36 mental component, 47.8, 51.9, 53.8, 50.9 and 46.9; %patients with spga clear or minimal disease, 26%, 85%, 80%, 69% and 3% (all p<0.001, except 70mg brodalumab, p<0.01). Total number of AEs per group, placebo, 23 (62%), 70mg, 26 (68%), 140mg, 27 (69%), 210mg, 33 (82%), 280mg, 30 (73%); serious AEs, 1 in both 70mg and 210mg brodalumab groups and 1 in placebo group. Brodalumab was discontinued in 3 (2%) patients. Common (at least 4 patients) AEs included: nasopharyngitis, upper respiratory tract infection, arthralgia, injection-site erythema, pain in extremity and nausea. - December % reported AEs by week 96. Most common AEs ( 10% of subjects), nasopharyngitis (25%), upper respiratory tract infection (18%) and arthralgia (13%). AEs grade 3 reported in 12.2% of subjects. Serious AEs reported in 6.6% of subjects, and included acute cholecystitis, constipation, pyelonephritis, oesophageal adenocarcinoma, fatal aortic aneurysm rupture and benign parathyroid tumour. Trial NCT , , EUCTR , AMAGINE-2; brodalumab vs. ustekinumab vs. placebo; phase III. NCT , , EUCTR , AMAGINE-3; brodalumab vs. ustekinumab vs. placebo; phase III. NCT , , EUCTR , , AMAGINE-1; brodalumab vs. placebo; phase III. Sponsor Amgen. Amgen. Amgen. Status Ongoing. Ongoing. Ongoing. Source of information Trial registry 26. Trial registry 27. Trial registry 28, press release 29. Location EU (not UK), USA, Canada and Australia. EU (not UK), USA, Canada, Australia and the EU (not UK), USA, Canada and Switzerland. Russian Federation. Design Randomised, active and placebo-controlled. Randomised, active and placebo-controlled. Randomised, placebocontrolled. Participants n=1,800 (planned); aged 18-75; moderate to severe plaque psoriasis for at least 6 months with BSA 10%, PASI 12 and spga 3 at screening and baseline. n=1,881 (planned); aged 18-75; moderate to severe plaque psoriasis with BSA 10%, PASI 12 and spga 3 at screening and baseline. n=661 (planned); aged 18-75; moderate to severe plaque psoriasis for at least 6 months with BSA 10%, PASI 12 and spga 3 at screening and baseline. e The Dermatology Life Quality Index. f 36-Item Short-Form Health Survey. 6

7 Schedule Randomised to: Arm 1 brodalumab 210mg or 140mg, SC on day 1, weeks 1 and 2, and every 2 weeks until week 12, when subjects rerandomised to receive brodalumab 210mg every 2 weeks or 140mg every 2, 4 or 8 weeks. Arm 2 ustekinumab 45mg or 90mg, SC on day 1 and weeks 4, 16, 28 and 40. At week 52, subjects switch to brodalumab 210mg every 2 weeks. Randomised to: Arm 1 brodalumab 210mg or 140mg, SC on day 1, weeks 1 and 2, and every 2 weeks until week 12, when subjects rerandomised to receive brodalumab 210mg every 2 weeks or 140mg every 2, 4 or 8 weeks. Arm 2 ustekinumab 45mg or 90mg, SC on day 1 and weeks 4, 16, 28 and 40. At week 52, subjects switch to brodalumab 210mg every 2 weeks. Randomised to brodalumab 210mg or 140mg, all SC and given on day 1, weeks 1, 2, and then every 2 weeks until week 12, subjects then rerandomised to continue treatment or receive placebo SC; or placebo SC until week 12 and then assigned to receive 210mg brodalumab. Follow-up Arm 3 placebo, SC on day 1, weeks 1 and 2, and every 2 weeks until week 12, when subjects assigned to brodalumab 210mg every 2 weeks. Induction period 12 weeks, maintenance 40 weeks and long-term extension period up to 5 years. Follow-up 5 years. Improvement in PASI; spga score. Patient reported outcomes symptom score; AEs; presence of antibrodalumab antibodies. Arm 3 placebo, SC on day 1, weeks 1 and 2, and every 2 weeks until week 12, when subjects assigned to brodalumab 210mg every 2 weeks. Induction period 12 weeks, maintenance 40 weeks and long-term extension period up to 5 years. Follow-up 5 years. Improvement in PASI; spga score. Patient reported outcomes symptom score; AEs; presence of antibrodalumab antibodies. Follow-up period 5 years and 3 months. Primary outcome/s Improvement in PASI; spga score. Secondary Patient reported outcomes outcome/s symptom score; AEs; presence of antibrodalumab antibodies. Key results - - PASI response for 210mg brodalumab, 140mg brodalumab vs placebo, respectively: PASI 75 response, 83.3%, 60.3% vs 2.7%; PASI 90 response, 70.3%, 42.5% vs 0.9%; PASI 100 response, 41.9%, 23.3% vs 0.5%. Adverse effects (AEs) Expected reporting date - - Most common AEs (>5% of participants), nasopharyngitis, upper respiratory tract infection and headache; serious AEs, 1.8% in 210mg group, 2.7% in 140mg group and 1.4% in placebo group. Q Q Q

8 ESTIMATED COST and IMPACT COST The cost of brodalumab is not yet known. The costs of other biological therapies for psoriasis are detailed below 30. Drug Dose Unit cost Annual cost Adalimumab Initially 80mg SC, then 352 (40mg, prefilled 9,504 (Humira) 40mg on alternate weeks, one week after initial dose. syringe). Etanercept 25mg SC twice weekly 89 (25mg, prefilled 9,256 (Enbrel) Infliximab (Remicade) Ustekinumab (Stelara) or 50mg once weekly. 50mg/kg intravenously repeated 2 weeks and 6 weeks after initial dose and then every 8 weeks. Initially 45mg SC, then 45mg 4 weeks after initial dose, then 45mg every 12 weeks. syringe). 420 (100mg, vial). 11,760 g 2147 (45mg, prefilled syringe). 12,882 IMPACT - SPECULATIVE Impact on Patients and Carers Reduced mortality/increased length of survival Other: improved quality of life and wider societal benefits (e.g. earlier return to normal activities, including employment). Reduced symptoms or disability No impact identified Impact on Health and Social Care Services Increased use of existing services Re-organisation of existing services Other: Decreased use of existing services Need for new services None identified Impact on Costs and Other Resource Use Increased drug treatment costs Other increase in costs: Other: uncertain unit cost compared to existing treatments Other Issues Clinical uncertainty or other research question identified: Reduced drug treatment costs Other reduction in costs: specify, None identified None identified g Average adult bodyweight (Health Survey for England (HSE) 2010): adults 77.9kg. 8

9 REFERENCES 1 American Academy of Dermatology working group. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. Journal of the American Academy of Dermatology 2011;65: Patient.co.uk. Psoriasis. November Accessed 8 May Psoriasis Association. March Accessed 8 May National Institute for Health and Care Excellence. The assessment and management of psoriasis. Clinical Guideline CG153. Manchester: NICE; October American Academy of Dermatology working group. Guidelines for the management of psoriasis and psoriatic arthritis. Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. Journal of the American Academy of Dermatology 2008;58: Armstrong AW, Schupp C, Wu J, et al. Quality of life and work productivity impairment among psoriasis patients: findings from the national psoriasis foundation survey data PLOS ONE 2012;7(12):e Gefland JM, Weinstein R, Porter SB, et al. Prevalence and treatment of psoriasis in the United Kingdom: a population-based study. Archives of Dermatology 2005;141(12): National Institute for Health and Care Excellence. Costing statement: Ustekinumab for the treatment of adults with moderate to severe psoriasis. London: NICE; September Chaplin S and Atherton D. Etanercept: a new option in paediatric plaque psoriasis. Future Prescriber 2009;9(3): Tofacitinib for moderate to severe chronic plaque psoriasis second line. University of Birmingham, November Health and Social Care Information Centre. Hospital episode statistics for England. Admitted patient care, Office for National Statistics. Mortality statistics: deaths registered in England and Wales (Series DR) Table NHS Clinical Knowledge Summary. Psoriasis. December Accessed 7 May Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults. National clinical guideline 121. Edinburgh: SIGN; October National Institute for Health and Care Excellence. The assessment and management of psoriasis. Clinical guideline CG153. Manchester: NICE; October Dimethyl fumarate for plaque psoriasis. University of Birmingham, November Hsu S, Papp KA, Lebwohl MG et al. Consensus guidelines for the management of plaque psoriasis. Archives of Dermatology. 2012;148(1): Smith CH, Anstey AV, Barker JN et al. British Association of Dermatologists' guidelines for biologic interventions for psoriasis British Journal of Dermatology 2009;161(5): National Institute for Health and Care Excellence. Psoriasis: final scope. London: NICE; December British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BNF 63. London: BMJ Group and RPS Publishing, March Gordon KB, Kimball AB, Chau D et al. Impact of brodalumab treatment on psoriasis symptoms and health-related quality of life: use of a novel patient-reported outcome measure, the Psoriasis Symptom Inventory. British Journal of Dermatology 2014;170: Papp KA, Leonardi C, Menter A et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. The New England Journal of Medicine 2012;366(13): ClinicalTrials.gov. Study to evaluate the safety, tolerability, and efficacy of AMG 827 in subjects with psoriasis. Accessed 30 April Papp K, Menter A, Milmont C et al. Maintenance of clinical response with long-term brodalumab (AMG 827) therapy for psoriasis: week 96 results from an open-label extension study. Journal of the American Academy of Dermatology 2014;70(5):Supplement 1, page AB174. 9

10 25 ClinicalTrials.gov. Study to assess the long-term safety, tolerability, and efficacy of AMG 827 in subjects with psoriasis. Accessed 30 April ClinicalTrials.gov. Study of efficacy and safety of brodalumab compared with placebo and ustekinumab in moderate to severe plaque psoriasis subjects (AMAGINE-2). Accessed 30 April ClinicalTrials.gov. Study of efficacy and safety of brodalumab compared with placebo and ustekinumab in moderate to severe plaque psoriasis subjects (AMAGINE-3). Accessed 30 April ClinicalTrials.gov. Study of efficacy, safety, and withdrawal and retreatment with brodalumab in moderate to severe plaque psoriasis subjects (AMAGINE-1). Accessed 30 April FierceBiotech. Amgen and AstraZeneca announce positive results from phase 3 study of brodalumab (AMG 827) in patients with moderate-to-severe plaque psoriasis. 9 May British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BNF 67. London: BMJ Group, RCPCH Publications, Ltd and the Royal Pharmaceutical Society of Great Britain,

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