Objective To evaluate the effect of secukinumab, an interleukin-17A inhibitor, on clinical signs and symptoms and radiographic changes through 2 years in patients with ankylosing spondylitis (AS).
Methods In the phase III MEASURE 1 study, patients were randomised to receive intravenous secukinumab 10 mg/kg (at baseline, week 2 and week 4) followed by subcutaneous secukinumab 150 mg (intravenous 150 mg; n=125) or 75 mg (intravenous 75 mg; n=124) every four weeks, or matched placebo (n=122). Placebo-treated patients were re-randomised to subcutaneous secukinumab 150 or 75 mg from week 16. Clinical efficacy assessments included Assessment of SpondyloArthritis international Society 20 (ASAS20) response rates through week 104. Radiographic changes at week 104 were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).
Results 97 (77.6%) and 103 (83.1%) patients in the intravenous 150 mg and intravenous 75 mg groups, respectively, completed week 104. In the full analysis set (intent-to-treat), ASAS20 response rates at week 104 were 73.7% and 68.0% in the intravenous 150 mg and intravenous 75 mg groups, respectively. Among patients with evaluable X-rays who were originally randomised to secukinumab (n=168), mean change in mSASSS from baseline to week 104 was 0.30±2.53. Serious adverse events were reported in 12.2% and 13.4% of patients in the 150 mg and 75 mg groups, respectively.
Conclusions Secukinumab improved AS signs and symptoms through 2 years of therapy, with no unexpected safety findings. Data from this study suggest a low mean progression of spinal radiographic changes, which will need to be confirmed in longer-term controlled studies.
Trial registration number NCT01358175.
- Ankylosing Spondylitis
- DMARDs (biologic)
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Handling editor Tore K Kvien
Contributors JB, JS, DB, XB, AD, PE, HBR, RM and SM were involved in the design of the study. DB, AD, JS and JB enrolled subjects into the study. All authors contributed to the analysis and interpretation of the data.
Funding This clinical trial was sponsored by Novartis Pharma AG. Medical writing support was provided by Chris Strutynskyj-Stannard, Joanne Fitz-Gerald, and Rugina Ali from Seren Communications, an Ashfield company, part of UDG Healthcare plc, the funding for which was provided by Novartis.
Competing interests JB has received honoraria for talks, advisory boards, paid consultancies and grants for studies from Abbott/AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB. XB has served as a consultant or paid speaker for or participated in clinical trials sponsored by AbbVie, Boehringer Ingelheim, Celgene, Centocor, Chugai, MSD, Novartis, Pfizer and UCB. AD has received research grants and honorarium for serving on the advisory boards of AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB. DB has served as a consultant or paid speaker for or participated in clinical trials sponsored by AbbVie, BMS, Boehringer Ingelheim, Glenmark, Janssen, Eli Lilly, MSD, Novartis, Novo Nordisk, Pfizer, Roche and UCB. JS has served as a consultant or paid speaker for or participated in clinical trials sponsored by AbbVie, Janssen, Eli Lilly, Merck, Novartis, Pfizer and UCB. PE has participated in clinical trials for and provided expert advice to AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, Samsung, Takeda and UCB. AR, RM and HBR are employees of Novartis. AR and HBR own Novartis stock.
Patient consent Obtained.
Ethics approval The study was conducted in accordance with Good Clinical Practice and the principles of the Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement A copy of the study protocol is available on request from the study sponsors.
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