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IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial

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机构： [a]Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, The Second Military Medical University, Shanghai, China [b]Department of Rheumatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China [c]Department of Rheumatology, The First Affiliated Hospital of Soochow University, Suzhou, China [d]Department of Rheumatology, Qingdao Municipal Hospital, Qingdao, China [e]Department of Rheumatology, The First Affiliated Hospital of Xiamen University, Xiamen, China [f]Department of Rheumatology, Nanfang Hospital, Southern Medical University, Guangzhou, China [g]Department of Rheumatology, Peking University People's Hospital, Beijing, China [h]Department of Rheumatology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China [i]Department of Rheumatology, Anhui Provincial Hospital, Hefei, China [j]Department of Rheumatology, Jiangsu Province Hospital, Nanjing, China [k]Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China [l]Department of Rheumatology, China-Japan Friendship Hospital of Jilin University, Changchun, China [m]Department of Rheumatology, The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia Autonomous Region, China [n]Department of Rheumatology, The First Affiliated Hospital of Shantou University Medical College, Shantou, China [o]Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, China [p]Department of Rheumatology, Xuanwu Hospital Capital Medical University, Beijing, China [q]Department of Rheumatology, The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology, Baotou, China [r]Department of Rheumatology, The First Affiliated Hospital of XinJiang Medical University, Urumqi, China [s]Department of Rheumatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China [t]Department of Rheumatology, The First Hospital of China Medical University, Shenyang, China [u]Department of Medical Science, Innovent Biologics, Suzhou, China [v]Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China [w]Peking-Tsinghua Center for Life Sciences, Tsinghua University, Beijing, China

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Background: China approved adalimumab for the treatment of ankylosing spondylitis in 2013. However, the cost of the standard dose regimen exceeds ¥15 000 (around US$2250) per month, which is well beyond affordability for most Chinese patients. No biosimilars of adalimumab are available in China; IBI303 is a monoclonal antibody against TNFα that is currently in development. This study aimed to assess the clinical equivalence of IBI303 to adalimumab in patients with ankylosing spondylitis. Methods: This phase 3, multicenter, double-blind, parallel, randomised controlled equivalence trial was done in 20 centers across China. Patients were randomly assigned in a 1:1 ratio to receive either 40 mg of IBI303 or 40 mg of adalimumab as a subcutaneous injection every 2 weeks until week 22. Patients were eligible for inclusion if they were between 18 and 65 years old, fulfilled the 1984 Modified New York Criteria for ankylosing spondylitis, were non-responders, inadequate responders, or intolerant to treatment with NSAIDs for 4 or more weeks, and had active ankylosing spondylitis defined by two or more indicators of disease severity. The investigators, site staff, patients, sponsors, and the contract research organisation were masked to treatment allocation. The primary outcome was the proportion of patients who met the Assessment of SpondyloArthritis international Society (ASAS) Response Criteria for a 20% improvement (ASAS20) at week 24 after treatment. Equivalence was established if the 95% CI of the difference in responses between groups was between −15% and 15%. Efficacy analyses were done in the full analysis population and in the per-protocol population. Safety analyses were done in all randomly assigned patients who received at least one drug dose. This trial is registered with ClinicalTrials.gov, number NCT02893254. Findings: Between Sept 22, 2016, and May 11, 2018, 438 patients were randomly allocated either to the biosimilar IBI303 group (n=220) or the adalimumab group (n=218). In the full analysis population, 165 (75%) of 220 patients in the IBI303 group (95% CI 68·7–80·6) and 158 (72%) of 218 patients in the adalimumab group (66·0–78·3) reached the primary outcome of ASAS20 at week 24. The difference between the two groups was 2·3% with a 95% CI of −5·9 to 10·6, which fell within the pre-specified equivalence boundaries at week 24 (–15 to 15). In the per-protocol population, 163 (80%) of 203 patients in the IBI303 group reached ASAS20 at week 24 (95% CI 74·1–85·5), compared with 150 (80%) of 188 patients in the adalimumab group (73·3–85·3%). The difference between the groups was 0·6% with a 95% CI of −7·4 to 8·6%, which also fell within the pre-specified equivalence boundaries at week 24. Safety and tolerability profiles were similar between the two groups; 174 (79%) of 220 patients in the IBI303 group and 178 (82%) of 218 patients in the adalimumab group had treatment-emergent adverse events. Interpretation: This trial showed therapeutic equivalence of IBI303 and adalimumab in the treatment of ankylosing spondylitis. The efficacy, safety, and immunogenicity of both drugs are highly similar. IBI303 could be an alternative treatment option for patients with ankylosing spondylitis in China. Funding: Innovent Biologics, National Major Scientific and Technological Special Project for “Significant New Drugs Development”. © 2019 Elsevier Ltd

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大类 | 1 区医学

小类 | 1 区风湿病学

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