Mitsumasa Kishimoto1, Atsuo Taniguchi2, Ayako Fujishige3, Shuhei Kaneko3, Sibylle Haemmerle4, Brian O Porter5, Shigeto Kobayashi6. 1. Immuno-Rheumatology Center, St. Luke's International University and St Luke's International Hospital, Tokyo, Japan. 2. Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan. 3. Novartis Pharma K.K., Tokyo, Japan. 4. Novartis Pharma AG, Basel, Switzerland. 5. Novartis Pharmaceuticals Corporation, East Hanover, USA. 6. Juntendo Koshigaya Hospital, Juntendo University, Saitama, Japan.
Abstract
Objective: Secukinumab, a fully human monoclonal antibody that neutralizes interleukin-17A, improved the signs and symptoms of ankylosing spondylitis (AS) in three Phase 3 global studies (MEASURE 1, 2, and 3). Here, we describe the efficacy and safety results through Week 24 of a study of secukinumab in Japanese patients with active AS. Methods: In this multicenter, open-label, single arm, 52-week study, 30 AS patients self-administered secukinumab 150 mg subcutaneously at baseline, Weeks 1, 2, 3, and 4, and every 4 weeks thereafter. The primary efficacy endpoint was ASAS 20 response at Week 16. Overall safety and tolerability were assessed beyond Week 24 up to the data reporting cut-off date. Results: The ASAS 20 response rate was 70% (21/30) at Week 16, which was sustained to Week 24. Secukinumab was effective in various clinical outcomes including patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level. Comparable ASAS 20 and 40 responses were observed regardless of previous anti-TNF therapy. Secukinumab was well-tolerated with a safety profile consistent with previous reports. Conclusion:Secukinumab 150 mg provided sustained improvement in the signs and symptoms of Japanese AS patients through 24 weeks, with no new or unexpected safety signals.
RCT Entities:
Objective: Secukinumab, a fully human monoclonal antibody that neutralizes interleukin-17A, improved the signs and symptoms of ankylosing spondylitis (AS) in three Phase 3 global studies (MEASURE 1, 2, and 3). Here, we describe the efficacy and safety results through Week 24 of a study of secukinumab in Japanese patients with active AS. Methods: In this multicenter, open-label, single arm, 52-week study, 30 AS patients self-administered secukinumab 150 mg subcutaneously at baseline, Weeks 1, 2, 3, and 4, and every 4 weeks thereafter. The primary efficacy endpoint was ASAS 20 response at Week 16. Overall safety and tolerability were assessed beyond Week 24 up to the data reporting cut-off date. Results: The ASAS 20 response rate was 70% (21/30) at Week 16, which was sustained to Week 24. Secukinumab was effective in various clinical outcomes including patient's global assessment of disease activity, spinal pain, nocturnal pain, physical function, spinal mobility, and CRP level. Comparable ASAS 20 and 40 responses were observed regardless of previous anti-TNF therapy. Secukinumab was well-tolerated with a safety profile consistent with previous reports. Conclusion:Secukinumab 150 mg provided sustained improvement in the signs and symptoms of Japanese AS patients through 24 weeks, with no new or unexpected safety signals.
Authors: Roberta Ramonda; Mariagrazia Lorenzin; Maria Sole Chimenti; Salvatore D'Angelo; Antonio Marchesoni; Carlo Salvarani; Ennio Lubrano; Luisa Costa; Ylenia Dal Bosco; Elena Fracassi; Augusta Ortolan; Mario Ferraioli; Antonio Carriero; Elisa Visalli; Riccardo Bixio; Francesca Desiati; Alberto Bergamini; Elisa Pedrollo; Andrea Doria; Rosario Foti; Antonio Carletto Journal: Ther Adv Musculoskelet Dis Date: 2022-04-29 Impact factor: 3.625
Authors: María Aparicio; Carlos A Guillén-Astete; Clementina López-Medina; Carlos Sastre; Fernando J Rodríguez Martínez Journal: Rheumatol Ther Date: 2021-11-27