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Abstract
Background Secukinumab improved signs and symptoms of ankylosing spondylitis (AS) over 2 years in the MEASURE 2 study (NCT01649375).1,2
Objectives To report the efficacy and safety of secukinumab over 3 years from the MEASURE 2 study.
Methods 219 patients (pts) with active AS were randomised to subcutaneous secukinumab 150mg (72 pts), 75mg (73 pts) or placebo (PBO, 74 pts). At Week (Wk) 16, PBO treated pts were re-randomised 1:1 to secukinumab 150mg or 75mg, irrespective of clinical response. Pts initially randomised to secukinumab and those who switched from PBO to secukinumab at Wk 16 were included in the analysis (secukinumab 150mg, N=106 and secukinumab 75mg, N=105). Outcome measures at Wk 156 included ASAS20 and 40, ASDAS-CRP inactive disease, ASAS5/6, BASDAI, SF-36 PCS and ASAS partial remission. Data are reported as observed. Safety analyses included all pts who received ≥1 dose of secukinumab.
Results At 156 wks, the completion rates for secukinumab 150mg was 81.1% (86/106) and 72.4% (76/105) for 75mg. Higher discontinuation rates for 75mg were in part due to lack of efficacy or patient/guardian decision. Efficacy observed across endpoints from Wks 52 to 156 are summarised in the Table. Higher responses were observed in the 150mg group (Table and Figure). Over the entire study period, the mean exposure [±SD] to secukinumab was 914.3±315.5 days. The exposure-adjusted incidence rates with Any secukinumab for infections/infestations, Crohn's disease, malignant/unspecified tumours and major adverse cardiovascular events were 1.5, 0.6, 0.6 and 0.6 per 100 pt-years, respectively.
Summary of Efficacy Results at Wks 52 and 156
Conclusions Secukinumab 150mg provided sustained improvement in the signs & symptoms along with physical functions with over 80% retention rate through 3 years in pts with AS. Safety profile remained favourable and was consistent with previous reports.1,2
References
Baeten et al. N Engl J Med. 2015;373:2534–48.
Marzo-Ortega et al. Ann Rheum Dis. 2016;75:812–3.
References
Disclosure of Interest H. Marzo-Ortega Grant/research support from: Janssen and Pfizer, Consultant for: Abbvie, Celgene, Janssen, Novartis and UCB, Speakers bureau: Abbvie, Celgene, Janssen and UCB, C. Legerton Grant/research support from: AbbVie, Ablynx, Acerta, Amgen, AstraZeneca, Celgene, GSK, Janssen, E. Lilly, BMS, Pfizer, Novartis, Sandoz, UCB, Daiichi Sankyo, ChemoCentryx, Boehringer Ingelheim, Speakers bureau: Novartis, Celgene and Amgen, J. Sieper Grant/research support from: AbbVie, Pfizer and Merck, Consultant for: AbbVie, Pfizer, Merck, UCB and Novartis, Speakers bureau: AbbVie, Pfizer, Merck and UCB, A. Kivitz Consultant for: AbbVie, Pfizer, Genentech, UCB and Celgene, Speakers bureau: AbbVie, Pfizer, Genentech, UCB and Celgene, R. Blanco: None declared, M. Cohen Consultant for: Abbvie, Amgen, BMS, Celgene, Hospira, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, Speakers bureau: Abbvie, Amgen, BMS, Celgene, Hospira, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, E. M. Delicha Employee of: Novartis, S. Rohrer Shareholder of: Novartis, Employee of: Novartis, H. Richards Shareholder of: Novartis, Employee of: Novartis