Secukinumab in active rheumatoid arthritis after anti-TNFα therapy: A randomized, double-blind placebo-controlled phase 3 study

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Created On: 18/02/2020

Secukinumab in active rheumatoid arthritis after anti-TNFα therapy: A randomized, double-blind placebo-controlled phase 3 study

The study involved Secukinumab safety and efficacy among the RA patients who failed to the response against tumour necrosis factor inhibitors (TNF-inhibitors).

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Key take away

Interleukin (IL-17A), the critical pro-inflammatory cytokine recognized as a key cytokine in the pathogenesis of rheumatoid arthritis (RA). Secukinumab (AIN457), a human monoclonal antibody that neutralizes the activity of IL-17A. Several phase II trials showed some efficacy of secukinumab in RA but did not allow for definitive conclusions. Therefore, this study demonstrated the effectiveness of secukinumab in reducing disease activity in RA patients who had an inadequate response to TNF-inhibitors.

Background

The study involved Secukinumab safety and efficacy among the RA patients who failed to the response against tumour necrosis factor inhibitors (TNF-inhibitors).

Method

Six hundred and thirty-seven patients randomized to obtain 10 mg/kg intravenous Secukinumab proceeded by subcutaneous 150 mg or 75 mg Secukinumab every four weeks (starting from week 8) or placebo at the same dosing catalogue. The American College of Rheumatology 20% improvement criteria (ACR20) at week 24 was taken as the primary endpoint. Further, other predefined hierarchical endpoints involved van der Heijde modified total Sharp score (vdH-mTSS), Health Assessment Questionnaire-Disability Index at week 24, and significant clinical response (MCR; continuous 6 month period of ACR70 response) at 12 months.

Result

Both Secukinumab groups exhibited a 35.2% ACR20 response rate as compared to 19.6% for placebo at week 24. Further Secukinumab dose groups also exhibited more significant improvements in secondary endpoints than placebo but not able to meet statistical significance. All treatment groups exhibited a similar inclusive safety profile.