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

Hasan Tahir, Atul Deodhar, Mark Genovese, Tsutomu Takeuchi, Jacob Aelion, Filip Van den Bosch (UGent) , Sibylle Haemmerle and Hanno B Richards
(2017) RHEUMATOLOGY AND THERAPY. 4(2). p.475-488
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Abstract
Introduction: 'REASSURE' (NCT01377012), a phase 3 study, evaluated the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response to, or intolerance of, tumor necrosis factor inhibitors (TNF-inhibitors). Methods: A total of 637 patients were randomized (1: 1: 1) to receive intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous secukinumab 150 mg or 75 mg every 4 weeks (starting from week 8) or placebo at the same dosing schedule. The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) at week 24. Other predefined hierarchical endpoints included Health Assessment Questionnaire-Disability Index, van der Heijde modified total Sharp score (vdH-mTSS) at week 24, and major clinical response (MCR; continuous 6 month period of ACR70 response) at 1 year. Results: The primary efficacy endpoint was met with both secukinumab dose groups: ACR20 response rate at week 24 was 35.2% for both secukinumab dose groups (P = 0.0009) vs 19.6% for placebo. The improvements in secondary endpoints were greater in the secukinumab dose groups vs placebo but did not meet statistical significance. The overall safety profile was similar across all treatment groups. Conclusion: Secukinumab demonstrated efficacy in reducing disease activity over placebo as measured by ACR20 in patients with active RA who had an inadequate response to TNF-inhibitors. Secukinumab demonstrated a safety profile similar to other biologics currently approved for RA.
Keywords
ACR, Autoimmune, Biologic, Clinical trial, HAQ-DI, IL-17A, Randomized, Rheumatoid arthritis, Secukinumab, vdH-mTSS, PSORIATIC-ARTHRITIS, SAFETY, INTERLEUKIN-17, EFFICACY, TRIAL, METHOTREXATE, MULTICENTER, ADALIMUMAB, RECEPTORS, IL-17

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MLA
Tahir, Hasan, et al. “Secukinumab in Active Rheumatoid Arthritis after Anti-TNFα Therapy : A Randomized, Double-Blind Placebo-Controlled Phase 3 Study.” RHEUMATOLOGY AND THERAPY, vol. 4, no. 2, 2017, pp. 475–88, doi:10.1007/s40744-017-0086-y.
APA
Tahir, H., Deodhar, A., Genovese, M., Takeuchi, T., Aelion, J., Van den Bosch, F., … Richards, H. B. (2017). Secukinumab in active rheumatoid arthritis after anti-TNFα therapy : a randomized, double-blind placebo-controlled phase 3 study. RHEUMATOLOGY AND THERAPY, 4(2), 475–488. https://doi.org/10.1007/s40744-017-0086-y
Chicago author-date
Tahir, Hasan, Atul Deodhar, Mark Genovese, Tsutomu Takeuchi, Jacob Aelion, Filip Van den Bosch, Sibylle Haemmerle, and Hanno B Richards. 2017. “Secukinumab in Active Rheumatoid Arthritis after Anti-TNFα Therapy : A Randomized, Double-Blind Placebo-Controlled Phase 3 Study.” RHEUMATOLOGY AND THERAPY 4 (2): 475–88. https://doi.org/10.1007/s40744-017-0086-y.
Chicago author-date (all authors)
Tahir, Hasan, Atul Deodhar, Mark Genovese, Tsutomu Takeuchi, Jacob Aelion, Filip Van den Bosch, Sibylle Haemmerle, and Hanno B Richards. 2017. “Secukinumab in Active Rheumatoid Arthritis after Anti-TNFα Therapy : A Randomized, Double-Blind Placebo-Controlled Phase 3 Study.” RHEUMATOLOGY AND THERAPY 4 (2): 475–488. doi:10.1007/s40744-017-0086-y.
Vancouver
1.
Tahir H, Deodhar A, Genovese M, Takeuchi T, Aelion J, Van den Bosch F, et al. Secukinumab in active rheumatoid arthritis after anti-TNFα therapy : a randomized, double-blind placebo-controlled phase 3 study. RHEUMATOLOGY AND THERAPY. 2017;4(2):475–88.
IEEE
[1]
H. Tahir et al., “Secukinumab in active rheumatoid arthritis after anti-TNFα therapy : a randomized, double-blind placebo-controlled phase 3 study,” RHEUMATOLOGY AND THERAPY, vol. 4, no. 2, pp. 475–488, 2017.
@article{8540705,
  abstract     = {{Introduction: 'REASSURE' (NCT01377012), a phase 3 study, evaluated the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response to, or intolerance of, tumor necrosis factor inhibitors (TNF-inhibitors). 
Methods: A total of 637 patients were randomized (1: 1: 1) to receive intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous secukinumab 150 mg or 75 mg every 4 weeks (starting from week 8) or placebo at the same dosing schedule. The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) at week 24. Other predefined hierarchical endpoints included Health Assessment Questionnaire-Disability Index, van der Heijde modified total Sharp score (vdH-mTSS) at week 24, and major clinical response (MCR; continuous 6 month period of ACR70 response) at 1 year. 
Results: The primary efficacy endpoint was met with both secukinumab dose groups: ACR20 response rate at week 24 was 35.2% for both secukinumab dose groups (P = 0.0009) vs 19.6% for placebo. The improvements in secondary endpoints were greater in the secukinumab dose groups vs placebo but did not meet statistical significance. The overall safety profile was similar across all treatment groups. 
Conclusion: Secukinumab demonstrated efficacy in reducing disease activity over placebo as measured by ACR20 in patients with active RA who had an inadequate response to TNF-inhibitors. Secukinumab demonstrated a safety profile similar to other biologics currently approved for RA.}},
  author       = {{Tahir, Hasan and Deodhar, Atul and Genovese, Mark and Takeuchi, Tsutomu and Aelion, Jacob and Van den Bosch, Filip and Haemmerle, Sibylle and Richards, Hanno B}},
  issn         = {{2198-6576}},
  journal      = {{RHEUMATOLOGY AND THERAPY}},
  keywords     = {{ACR,Autoimmune,Biologic,Clinical trial,HAQ-DI,IL-17A,Randomized,Rheumatoid arthritis,Secukinumab,vdH-mTSS,PSORIATIC-ARTHRITIS,SAFETY,INTERLEUKIN-17,EFFICACY,TRIAL,METHOTREXATE,MULTICENTER,ADALIMUMAB,RECEPTORS,IL-17}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{475--488}},
  title        = {{Secukinumab in active rheumatoid arthritis after anti-TNFα therapy : a randomized, double-blind placebo-controlled phase 3 study}},
  url          = {{http://doi.org/10.1007/s40744-017-0086-y}},
  volume       = {{4}},
  year         = {{2017}},
}
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