RT Journal Article
SR Electronic
T1 FRI0379 LONG-TERM EVALUATION OF SECUKINUMAB 150 MG IN ANKYLOSING SPONDYLITIS: 5-YEAR END-OF-STUDY EFFICACY AND SAFETY RESULTS FROM A PHASE 3 TRIAL
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 873
OP 873
DO 10.1136/annrheumdis-2019-eular.5531
VO 78
IS Suppl 2
A1 Helena Marzo-Ortega
A1 Joachim Sieper
A1 Alan Kivitz
A1 Ricardo Blanco
A1 Martin Cohen
A1 Karel Pavelka
A1 Eumorphia Maria Delicha
A1 Anna Stefanska
A1 Hanno Richards
A1 Susanne Rohrer
YR 2019
UL http://ard.bmj.com/content/78/Suppl_2/873.1.abstract
AB Background Evaluation of long-term efficacy and safety for treatments for ankylosing spondylitis (AS) is important. Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has shown significant and sustained improvement in the signs and symptoms of AS through 3 years in the MEASURE 2 study (NCT01649375).1 Objectives We report the 5-year end-of-study results of subcutaneous (s.c.) secukinumab 150 mg in the MEASURE 2 study.Methods AS patients (pts; N = 219) were randomised to receive s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks (Wks) 1, 2 and 3 and every 4 wks from Wk 4. At Wk 16, placebo-treated pts were re–randomised to receive secukinumab 150/75 mg. Efficacy results are reported for pts initially randomised to secukinumab 150 mg and those who switched from placebo to secukinumab 150 mg at Wk 16 (N = 106). An optional dose escalation from secukinumab 75 mg to 150 mg was initiated beginning Wk 140. Outcome measures at Wk 260 included ASAS20/40, BASDAI50, BASMI, BASFI, SF-36 PCS and ASAS partial remission. Analyses stratified by anti-TNF status (anti–TNF-naïve and anti-TNF inadequate response [IR]) were performed. Safety analysis included all pts who received ≥1 dose of secukinumab. Results are reported as observed.Results The retention rate to Wk 260 was 77% (82/106) for secukinumab 150 mg. Sustained efficacy was observed with secukinumab 150 mg across all endpoints through 5 years (Table). Improvements were maintained regardless of prior exposure to anti–TNF therapy with greater responses in anti–TNF-naïve pts. A total of 49 pts on secukinumab 75 mg (46.7%) escalated dose to 150 mg after Wk 140; efficacy responses improved in pts whose dose was escalated. Over the entire study period, the mean exposure (±SD) to secukinumab was 1459.1 ± 597.8 days. Exposure-adjusted incidence rates (per 100 pt-years) with any secukinumab dose for selected adverse events were: Candida infections (1.0), Crohn’s disease (0.5), major adverse cardiovascular events (0.7), uveitis (0.5), and malignant/unspecified tumours (0.5).Conclusion Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in pts with AS through 5 years of treatment. The safety profile of secukinumab remained consistent with previous reports.1–3 References [1] Marzo-Ortega, et al. RMD Open. 2017;3:e000592; 2. Marzo-Ortega, et al. Ann Rheum Dis. 2016;75:812–3; 3. Baraliakos X,et al. Clin Exp Rheumatol2017.Disclosure of Interests Helena Marzo-Ortega Grant/research support from: Janssen, Novartis and Pfizer, Consultant for: AbbVie, Celgene, Janssen, Eli-Lilly, Novartis and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Eli-Lilly, Novartis and UCB, Joachim Sieper Consultant for: Abbvie, Böhringer Ingelheim, Janssen, Lilly, Merck, Mylan, Novartis, Pfizer, UCB., Speakers bureau: Abbvie, Böhringer Ingelheim, Janssen, Lilly, Merck, Mylan, Novartis, Pfizer, UCB., Alan Kivitz Shareholder of: Novartis, Consultant for: Abbvie, Janssen, Pfizer, UCB, Genzyme, Sanofi, Regeneron, Boehringer Ingelheim, Sun Pharma Advanced Research, Flexion., Paid instructor for: Celgene, Horizon, Merck, Novartis, Pfizer, Genzyme, Sanofi, Regeneron, Speakers bureau: Celgene, Horizon, Merck and Genetech, Flexion, Ricardo Blanco Grant/research support from: Abbvie, MSD and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Martin Cohen Consultant for: AbbVie, Amgen, Celgene, Lilly, Novartis, Pfizer, Sandoz, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Celgene, Janssen, Merck, Novartis and Pfizer, Karel Pavelka: None declared, Eumorphia Maria Delicha Employee of: Novartis, Anna Stefanska Shareholder of: Novartis, Employee of: Novartis, Hanno Richards Shareholder of: Novartis Pharma AG, Employee of: Novartis Pharma AG, Susanne Rohrer Shareholder of: Novartis, Employee of: NovartisView this table:Table Efficacy Endpoints with Secukinumab 150 mg at Week 260 (5 year)