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Secukinumab efficacy persists at 3 years in ankylosing spondylitis
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Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis over a 3-year period, with no new safety signals, according to findings from an extension of the phase 3 MEASURE 1 trial, published in Clinical and Experimental Rheumatology.
“In two phase 3 studies, secukinumab ... significantly improved [ankylosing spondylitis] signs and symptoms versus placebo at 16 weeks,” Xenofon Baraliakos, MD, of Ruhr-University Bochum, in Herne, Germany, and colleagues wrote. “Similar efficacy was observed at 52 weeks and 2 years among subjects continuing treatment.”
To provide an update on the efficacy and safety of secukinumab, the researchers reported findings from year 1 of a noncontrolled extension of the 2-year MEASURE 1 trial, producing a total treatment time of 3 years. The extension study is scheduled to extend 3 years. Among the 290 patients who completed the initial MEASURE 1 trial — in which patients received either 150-mg or 75-mg doses of subcutaneous secukinumab every 4 weeks, following IV loading or initial placebo treatment to 16 or 24 weeks —274 participated in the extension. Of those, 260 completed 156 weeks of treatment.
The researchers assessed the patients using the Assessment of Spondyloarthritis International Society (ASAS) 20/40 response index, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), the Bath Ankylosing Spondylitis Functional Index (BASFI), a SF-36 physical component summary, ASAS partial remission and Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP).
According to the researchers, patients in the group that received 150-mg doses demonstrated ASAS 20/40 response rates of 80.2% and 61.6%, respectively, after 156 weeks. Among those in the 75-mg group, ASAS 20/40 response rates were 75.5% and 50%, respectively. The researchers reported sustained improvements in BASDAI, BASFI and BASMI, as well as across all other endpoints regardless of previous exposure to anti-TNF therapies.
The participating patients’ mean exposure to secukinumab was 137.8 weeks, with low discontinuation rates. In addition, secukinumab had a favorable safety profile, with incidence rates of 1.1 per 100 subject-years for serious infections, 0.4 for Candida infections, 0.5 for Crohn's disease, 0.1 for ulcerative colitis, 0.5 for malignant/unspecified tumors and 0.7 for adjudicated major cardiac events.
“Building on earlier findings, these results show sustained improvement through 3 years in signs, symptoms and physical function in [ankylosing spondylitis] subjects who remained on secukinumab 150 mg,” Baraliakos and colleagues wrote. “Discontinuation rates were low and secukinumab was well tolerated with a favorable safety profile, consistent with previous reports. This ongoing study will provide valuable longer-term data over a further 2 years.” – by Jason Laday
Disclosure: Baraliakos reports being a consultant for, receiving speaking fees from, and participating in studies funded by AbbVie, Boehringer Ingelheim, Celgene, Centocor, Chugai, MSD, Novartis, Pfizer and UCB. The researchers report funding from Novartis Pharma AG. Please see the full study for a list of all other authors’ relevant disclosures.
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