The Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab; Novartis) for the treatment of adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
The approval was based on data from the phase 3 PREVENT study that evaluated the efficacy and safety of secukinumab in 555 adults with active nr-axSpA who were biologic treatment naïve or had an inadequate response to an anti-tumor necrosis factor-α therapy (anti-TNFs). Patients were randomized to receive either secukinumab 150mg subcutaneously (SC) monthly with a loading dosage (secukinumab 150mg weekly for 4 weeks), secukinumab 150mg SC monthly with no loading dosage, or placebo.
Results showed that secukinumab met the primary end point achieving a statistically significant improvements in the Assessment of Spondyloarthritis International Society (ASAS40) response at week 52 in biologic treatment naïve patients, defined as a measure of improvement of ≥40% and ≥2 units on a scale of 10 in at least 3 of the 4 ASAS main domains and no worsening at all in the remaining domain.
At week 16, clinical response was observed in 40% (74/185) and 41% (75/184) of secukinumab-treated patients with or without the loading dosage, respectively, compared with 28% (52/186) of patients who received placebo. At week 52, clinical response was observed in 34% and 38% of secukinumab-treated patients and 19% of placebo-treated patients.
Additionally, both secukinumab treatment arms (with and without loading dosage) met the key secondary end points achieving improvement compared with placebo at week 16 in health-related quality of life as assessed by the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire (-3.5 and -3.6 vs -1.8, respectively). At week 16, secukinumab-treated patients also experienced greater improvements as measured by the hs-CRP (high sensitivity C-reactive protein over time), BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), and BASMI (Bath Ankylosing Spondylitis Metrology Index).
The safety profile of secukinumab was found to be consistent with that seen in previous trials. The most common adverse reactions associated with treatment included nasopharyngitis, diarrhea, and upper respiratory tract infection.
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