Horizon Scanning Centre March Ixekizumab for moderate to severe chronic plaque psoriasis SUMMARY NIHR HSC ID: 5209

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1 Horizon Scanning Centre March 2015 Ixekizumab for moderate to severe chronic plaque psoriasis SUMMARY NIHR HSC ID: 5209 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. Ixekizumab is intended for the treatment of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy. If licensed, ixekizumab will offer an additional treatment option for this patient group. Treatment with ixekizumab may result in some patients achieving near/full clearance of psoriasis symptoms. Ixekizumab is a humanised immunoglobulin G subclass 4 (IgG4) monoclonal antibody that neutralises interleukin-17a (IL-17), which is a key T cell-derived cytokine involved in inducing and mediating inflammation. It does not currently have Marketing Authorisation in the EU for any indication. The prevalence of psoriasis in England is estimated to be around 1.63%, equating to around 900,000 people with the condition. Plaque psoriasis accounts for around 90% of cases and approximately 20% have moderate to severe psoriasis (15% moderate, 5% severe). The estimated prevalence of people currently eligible for biological therapy in England is 3% of those with psoriasis, equating to around 27,000 people. However, because of the nature of the condition, not all patients eligible for biologic treatments will currently be identified and/or treated with these agents. In , there were 1,454 hospital admissions in England as a result of psoriasis vulgaris, equating to 1,537 finished consultant episodes and 3,912 bed days. Thirty deaths from psoriasis were registered in England and Wales during 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. Ixekizumab is currently in three phase III clinical trials comparing its effect on the Psoriasis Area Severity Index (PASI) against treatment with etanercept and placebo. These trials are expected to be completed by 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. NIHR Horizon Scanning Centre, University of Birmingham nihrhsc@contacts.bham.ac.uk Web:

2 TARGET GROUP Plaque psoriasis: moderate to severe; chronic adults who are candidates for systemic therapies. TECHNOLOGY DESCRIPTION Ixekizumb (LY , anti-il-17 monoclonal antibody) is a humanised immunoglobulin G subclass 4 (IgG4) monoclonal antibody that neutralises interleukin-17a (IL-17), which is a key T cell-derived cytokine involved in inducing and mediating inflammation. Ixekizumab is intended for the treatment of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy. It is administered subcutaneously (SC) at a frequency and dose to be determined from the company s phase III trial 1. The company anticipate that the dosing regimen will consist of a 160mg initial dose, followed by 80mg dosing through the induction and maintenance periods. Ixekizumab does not currently have Marketing Authorisation in the EU for any indication. Ixekizumab is also in phase III clinical trials for psoriatic arthritis; and phase II for rheumatoid arthritis. INNOVATION and/or ADVANTAGES If licensed, ixekizumab will offer an additional treatment option for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy. Treatment with ixekizumab may result in some patients achieving near/full clearance of psoriasis symptoms. DEVELOPER Eli Lilly and Company Limited. AVAILABILITY, LAUNCH OR MARKETING In phase III clinical trials. PATIENT GROUP BACKGROUND Psoriasis is an inflammatory skin condition characterised by well-defined, sharply demarcated, erythematous plaques, which can be one centimetre to several centimetres in size. Plaques may form across specific areas such as the scalp, trunk, limbs, buttocks, elbows and knees, but can also manifest across the entire body causing pain and pruritus. Plaques appear as dry, thin, silvery-white scales, and often smaller plaques merge forming larger plaques, particularly over the leg and trunk 2,3. The cause of psoriasis is not known although genetics, the environment, and an overactive immune system (in particular T cells) are thought to play a part 4. Psoriasis typically follows a relapsing and remitting course, with flare ups occurring spontaneously 5. Contributors to flare ups include stress, infections, medications, sunlight, trauma, hormonal changes, smoking and alcohol 3. 2

3 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 7. NHS or GOVERNMENT PRIORITY AREA This topic is relevant to: Department of Health. Improving quality of life for people with long term conditions (2013). NHS England NHS Standard Contract for Specialised Dermatology Services (All ages). A12/S/a. CLINICAL NEED and BURDEN OF DISEASE The prevalence of psoriasis in England is estimated to be around 1.63%, equating to approximately 900,000 people with the condition 8,a. Plaque psoriasis accounts for around 90% of cases and approximately 20% have moderate to severe disease (15% moderate, 5% severe) 8. Onset may occur at any age, although it is uncommon in children (prevalence 0.71%), with the majority of cases occurring before the age of 35. Life expectancy in men and women with severe psoriasis is reduced by 3.5 and 4.4 years respectively 9, primarily due to metabolic syndrome and heart disease 10. 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 12. Acute flares or relapses of plaque psoriasis may evolve into more severe disease, such as pustular or erythrodermic psoriasis 5. The estimated prevalence of people currently eligible for biological therapy in England is 3% 11 of those with psoriasis, equating to around 27,000 people. However, because of the nature of the condition, not all patients eligible for biologic treatments will currently be identified and/or treated with these agents 11. In , there were 1,454 hospital admissions in England as a result of psoriasis vulgaris (ICD-10 L40.0), equating to 1,537 finished consultant episodes and 3,912 bed days 12. Thirty deaths from psoriasis were registered in England and Wales during 2013 (ICD-10 L40) 13. PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance NICE technology appraisal in development. Psoriasis (plaque, moderate to severe) - apremilast [ID679]. Expected August NICE technology appraisal in development. Secukinumab for treating moderate to severe plaque psoriasis [ID718]. Expected July NICE technology appraisal. Ustekinumab for the treatment of adults with moderate to severe psoriasis (TA180). September a Based on Office for National Statistics mid-2013 population estimate for England. 3

4 NICE technology appraisal. Adalimumab for the treatment of adults with psoriasis (TA146). June 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 Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults (121) British Association of Dermatologists and Primary Care Dermatology Society. Clinical guideline: Recommendations for the initial management of psoriasis British Association of Dermatologists. Guidelines for biologic interventions for psoriasis 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 5. Current treatment options for plaque psoriasis include 16,17,18,19 : Topical (alone or in combination) Emollients. Corticosteroids: e.g. betamethasone dipropionate. Vitamin D analogues: calcipotriol, calcitriol, tacalcitol (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 conventional disease modifying therapies (for the treatment of patients with moderate to severe or refractory psoriasis) Oral retinoids: acitretin (with or without phototherapy). Hydroxycarbamide (not licensed for this indication). Ciclosporin. Methotrexate. 4

5 Apremilast. Biological therapies (for the treatment of patients with moderate to severe psoriasis who are candidates for systemic therapies) Secukinumab (IL-17A inhibitor). Biological therapies (for the treatment of patients intolerant, contraindicated or refractory to other systemic conventional disease modifying treatments and/or phototherapy) Adalimumab (TNF- Etanercept (TNF-nhibitor). Infliximab (TNF- Ustekinumab (IL-12 and IL-23 inhibitor). EFFICACY and SAFETY Trial UNCOVER-1, NCT , 12972, I1F-MC-RHAZ; ixekizumab vs placebo; phase III. UNCOVER-2, NCT , 12973, I1F-MC-RHBA; ixekizumab vs etanercept vs placebo; phase III. UNCOVER-3, NCT , 13685, I1F-MC-RHBC; ixekizumab vs etanercept vs placebo; phase III. Sponsor Eli Lilly and Company. Eli Lilly and Company. Eli Lilly and Company. Status Ongoing. Ongoing. Ongoing. Source of information Trials registry 1, press release 20. Trial registry 21, press release 24. Trial registry 22, press release 24. Location Design Participants Schedule EU (incl UK), USA, Canada and other countries. Randomised, placebocontrolled. n=1,296; aged 18 years and older; plaque psoriasis (at least 10% of body surface area); chronic; moderate to severe; spga b score of at least 3 and PASI c score of at least 12 at screening and at first dose of study drug; candidate for phototherapy and/or systemic therapy. Induction period (up to week 12): EU (incl UK), USA, Canada and other countries. Randomised, active- and placebo- controlled. n=1,224; aged 18 years and older; plaque psoriasis (at least 10% of body surface area); chronic; moderate to severe; spga score of at least 3 and PASI score of at least 12 at screening and at first dose of study drug; candidate for phototherapy and/or systemic therapy. Induction period (up to week 12): EU, USA, Canada and other countries. Randomised, active- and placebo- controlled. n=1,346; aged 18 years and older; plaque psoriasis (at least 10% of body surface area); chronic; spga score of at least 3 and PASI score of at least 12 at screening and at randomisation; candidate for phototherapy and/or systemic therapy. Induction period (up to week 12): Randomised to: Arm 1: ixekizumab 160mg SC injection at week 0, then ixekizumab 80mg once every two weeks for 12 At week 12, responders (spga 0 or 1) to treatment are re- Randomised to: Arm 1: ixekizumab 160mg SC injection at week 0, then ixekizumab 80mg once every two weeks for 12 At week 12, responders to treatment are re-randomised to Randomised to: Arm 1: ixekizumab 160mg SC injection at week 0, then ixekizumab 80mg once every two weeks for 12 At week 12, patients are assigned to dosing regimen 2. b The static PGA (spga) measures the physician s impression of the disease (psoriasis). c PASI (Psoriasis Area Severity Index) is an index used to express the severity of psoriasis. It combines severity (erythema, induration and desquamation) and percentage of affected body surface area. 5

6 Follow-up randomised to placebo, dosing regimen 2 or dosing regimen 3. Arm 2: ixekizumab 160mg SC injection at week 0, then ixekizumab 80mg once every four weeks for 12 At week 12, responders to treatment are re-randomised to placebo, dosing regimen 2 or dosing regimen 3. Placebo: placebo SC injection at week 0, then once every two weeks for 12 At week 12, placebo non-responders receive starting dose of ixekizumab 160mg SC, followed by ixekizumab 80mg SC every 4 weeks for 48 Placebo responders remain on placebo SC every 4 weeks until relapse whereupon patients are placed on every 4 Maintenance dosing period: Randomised to: Placebo: placebo SC every 4 weeks for 48 Dosing regimen 2: every 4 weeks for 48 Dosing regimen 3: every 12 weeks for 48 Non-responders (spga >1) at week 12 and patients who relapsed every 4 Induction plus maintenance treatment period up to 60 placebo, dosing regimen 2 or dosing regimen 3. Arm 2: ixekizumab 160mg SC at week 0, then ixekizumab 80mg once every four weeks for 12 At week 12, responders to treatment are re-randomised to placebo, dosing regimen 2 or dosing regimen 3. Arm 3: etanercept 50mg SC twice weekly for 12 At week 12, responders to treatment receive placebo every 4 weeks until relapse. Patients who relapse on placebo receive every 4 Placebo: placebo for ixekizumab SC at week 0, then once every two weeks for 12 Placebo for etanercept SC twice weekly for 12 At week 12, nonresponders to placebo receive ixekizumab 160mg (starting dose) followed by every 4 Maintenance dosing period: Randomised to: Placebo: placebo SC every 4 weeks for 48 Dosing regimen 2: every 4 weeks for 48 Dosing regimen 3: every 12 weeks for 48 Non-responders (spga >1) at week 12 and patients who relapsed on every 4 Induction plus maintenance treatment period up to 60 Arm 2: ixekizumab 160mg SC at week 0, then ixekizumab 80mg once every four At week 12 patients are assigned to dosing regimen 2. Arm 3: etanercept 50mg SC twice weekly for 12 At week 12, patients are assigned to dosing regimen 2. Placebo: placebo for ixekizumab SC at week 0, then once every two weeks for 12 Placebo for etanercept SC twice weekly for 12 At week 12, patients are assigned to dosing regimen 2. Long term extension period from week 12 up to week 264. Dosing regimen 2: ixekizumab 80mg every 4 Active treatment period 264 6

7 Long-term extension period up to 264 Long-term extension period up to 264 Primary PASI, spga. PASI, spga. PASI, spga outcome/s Secondary outcome/s Quality of life d. Quality of life. Quality of life. Key results For patients treated with ixekizumab either every four weeks or every two weeks, 78-90% achieved at least a 75% reduction in PASI score (PASI 75) at 12 Additionally, 31-41% of these patients achieved PASI 100, or clear skin, at week 12. For comparison 5-7% of patients treated with etanercept in the NCT and NCT studies achieved PASI 100. Adverse effects (AEs) Expected reporting date The most frequently reported AEs (more than 5% across all three studies) were nasopharyngitis and injection site reaction. Most injection site reactions were mild, and most patients who experienced an injection site reaction continued treatment with ixekizumab. Study completion date reported as Apr Study completion date reported as Dec Study completion date reported as Feb Trial Sponsor Status Source of information Location Design Participants Schedule Follow-up Primary outcome/s Secondary outcome/s Key results NCT , 12060, I1F-MC-RHAJ; ixekizumab vs placebo; phase II. Eli Lilly and Company. Ongoing and published. Trial registry 23, publication 24. USA and Denmark. Randomised, placebo-controlled. n=142; aged 18 years and older; plaque psoriasis (at least 10% of body surface area); chronic; moderate to severe; spga score of at least 3 at screening and at randomisation; candidate for systemic therapy. Participants must have completed treatment period part A before starting part B. Part A Randomised to ixekizumab 10mg, 25mg, 75mg, 150mg or placebo SC on weeks 0, 2, 4, 8, 12 and 16. Part B Participants receive every 4 weeks until week 236. Active treatment period up to 264 PASI 75. spga score up to 240 weeks, AEs, Hospital Anxiety and Depression Scale (HADS), 16-item Quick Inventory of Depressive Symptoms-Self Rated (QIDS-SR16), Patient global assessment (PatGA), pain Visual Analog Scale (VAS), Medical Outcomes Study Sleep Scale (MOS-S), Psoriasis Medical Care Resource Utilization (PMRU), Work Productivity and Activity Impairment Questionnaire (WPAIQ), medical outcomes study Short Form-36 (SF-36), Nail Psoriasis Severity Index (NAPSI) in participants with nail psoriasis, Scalp Psoriasis Severity Index (SPSI) in participants with scalp psoriasis, Palmoplantar Psoriasis Severity Index (PPSI) in participants with palmoplantar psoriasis, PASI score at week 240, Dermatology Life Quality Index (DLQI), PASI-75 at week 32, spga score of 0-1 with at least a 2 point improvement at week 32. For ixekizumab 10mg, 25mg, 75mg, 150mg vs placebo respectively (± standard deviation, p values vs placebo): d Measured through patient reported outcomes. 7

8 Adverse effects (AEs) Expected reporting date PASI 75 score, 29%, 77%, 83%, 82% vs 8%; PASI 90, 18%, 50%, 59%, 71% vs 0%; PASI 100, 0%, 17%, 38%, 39% vs 0; spga score (0 or 1), 25%, 70%, 72%, 71% vs 8%; spga score (0), 7%, 20% (p<0.05), 38% 001) vs 0. The most common adverse events were nasopharyngitis, upper respiratory infection, injection site reaction, and headache. Study completion date reported as Jul ESTIMATED COST and IMPACT COST The cost of ixekizumab is not yet known. The costs of other selected biological therapies for psoriasis are detailed below Drug Dose Unit cost Annual cost Adalimumab Initially 80mg SC, then 40mg on (40mg, 9,295. (Humira) alternate weeks, one week after initial dose. prefilled syringe). Etanercept 25mg SC twice weekly or 50mg (25mg, prefilled 9,295. (Enbrel) Infliximab (Remicade) Ustekinumab (Stelara) once weekly. 5mg/kg IV repeated 2 weeks and 6 weeks after initial dose and then every 8 Initially 45mg SC, then 45mg 4 weeks after initial dose, then 45mg every 12 syringe) (100mg, vial). 10,910 (following loading doses and based on average 6.5 doses per year). 2,147 (45mg, prefilled syringe). 12,882. IMPACT - SPECULATIVE Impact on Patients and Carers Reduced mortality/increased length of survival Other: Impact on quality of life of families/carers and patients, including social wellbeing and education. 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 8

9 Impact on Costs and Other Resource Use Increased drug treatment costs Other increase in costs: Other: uncertain unit cost compared to existing treatments, expert opinion suggests that indirect costs such as return to employment are also an important factor to consider e. Other Issues Clinical uncertainty or other research question identified: expert opinion implies that an important question to consider with these biological therapies is whether there are biomarkers (co-diagnostics) that can identify patients who are likely to be responders to these drugs based on modes of action. There is preliminary data that this concept may be real and it is therefore an important question for trials to address in the future maybe in drug development where there is adequate power to obtain good data e. Reduced drug treatment costs Other reduction in costs: None identified None identified REFERENCES 1 ClinicalTrials.gov. A multicentre study with a randomised, double-blind, placebo-controlled induction dosing period followed by a randomised maintenance dosing period and a long-term extension period to evaluate the efficacy and safety of LY in patients with moderate-tosevere plaque psoriasis. Accessed 17 March 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: Patient.co.uk. Psoriasis. November Accessed 17 March Psoriasis Association. About Psoriasis. March Accessed 17 March National Institute for Health and Clinical Excellence. The assessment and management of psoriasis. Clinical Guideline CG153. Manchester: NICE; October 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 NIHR Horizon Scanning Centre. Brodalumab for moderate to severe plaque psoriasis. University of Birmingham, May National Institute for Health and Care Excellence. Apremilast for treating moderate to severe plaque psoriasis. Final scope. London: NICE; October Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults. National clinical guideline 121. Edinburgh: SIGN; October NIHR Horizon Scanning Centre. Apremilast for psoriasis. University of Birmingham, January National Institute for Health and Care Excellence. Biologic drugs for the treatment of inflammatory disease in rheumatology, dermatology and gastroenterology. Commissioning guide: Implementing NICE guidance. November 2012 (update). e Expert personal communication. 9

10 12 Health & Social Care Information Centre. Hospital episode statistics for England. Inpatient statistics, Office for National Statistics. Mortality statistics: deaths registered in England and Wales (Series DR) British Association of Dermatologists & Primary Care Dermatology Society. Recommendations for the initial management of psoriasis. October PCDS%20Psoriasis%20reviewed% pdf Accessed 12 October 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): NIHR Horizon Scanning Centre. 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 Eli Lilly and Company. Lilly s ixekizumab superior to etanercept in placebo in phase 3 psoriasis studies. August ClinicalTrials.gov. A multicentre, randomised, double-blind, placebo-controlled study comparing the efficacy and safety of LY to etanercept and placebo in patients with moderate-tosevere plaque psoriasis. Accessed 17 March ClinicalTrials.gov. A 12-week multicentre, randomised, double-blind, placebo-controlled study comparing the efficacy and safety of LY to etanercept and placebo in patients with moderate to severe plaque psoriasis with a long-term extension period. Accessed 17 March ClinicalTrials.gov. A dose-ranging and efficacy study of LY (an anti-il-17 antibody) in patients with moderate-to-severe psoriasis. Accessed 17 March Leonardi C, Matherson R, Zachariae C et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. The New England Journal of Medicine 2012;366(13): National Institute for Health and Care Excellence. Adalimumab, etanercept and infliximab for the treatment of psoriatic arthritis: NICE; August The Royal Pharmaceutical Society. British National Formulary. BNF

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