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The primary results of PREVENT, the phase III study assessing secukinumab in active non‐radiographic axial spondyloarthritis (nr‐axSpA) patients has been reported in this study.
As per the primary outcomes of this randomized controlled
phase III study (PREVENT trial), secukinumab significantly improved disease
activity, physical function, quality of life, and objective signs of
inflammation in biologic therapy-naive or inadequate reaction to TNF-inhibition
in nr-axSpA patients. Both secukinumab routines (LD and NL) had an early and
sustained treatment effect through Week 52.
The primary results of PREVENT, the phase III study
assessing secukinumab in active non‐radiographic axial spondyloarthritis (nr‐axSpA) patients has been
reported in this study.
All in all, 555 patients were randomized to secukinumab 150 mg subcutaneously (SC) with loading (LD), without loading (NL), or placebo weekly and then, every 4 weeks beginning at Week 4. To maintain blinding, the NL group obtained placebo at Weeks 1, 2, and 3. After week 20, change to open‐label secukinumab (OL) or standard of care (SoC) was allowed.
The ASAS40 at Week 16 (LD) and Week 52 (NL) in tumour necrosis
factor inhibitor (TNFi)‐naïve patients was considered as the primary endpoint.
All the patients receiving ≥1 dose of study therapy was included in the safety
evaluates.
A total of 481 patients finished 52 weeks therapy: 84.3% (156/185) LD, 89.7% (165/184) NL, and 86.0% (160/186) placebo. Percentage of patients who switched to OL or SoC between Weeks 20 and 48 was 50.8% LD, 47.3% NL, and 64.0% placebo (figure 1).
Figure 1: Patients
switching to OL or SoC between Weeks 20 and 48
At week 16, both the primary and all secondary endpoints
were met. At Week 16, considerably higher ASAS40 in TNFi‐naïve patients for LD
(41.5%) and NL (39.8%) at Week 52 versus placebo was found.
Along with a consistent safety profile, secukinumab 150
mg provided significant and continued improvement in signs and symptoms of nr‐axSpA patients during 52 weeks.
Arthritis & Rheumatology
Secukinumab improves signs and symptoms of non‐radiographic axial spondyloarthritis: primary results of a randomized controlled phase III study
Atul Deadhar et al.
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