The 29th European Academy of Dermatology and Venereology (EADV) virtual conference is held from 29th to 31st October 2020. At this meeting, Henlius released the results of HLX03-Ps03, the Phase 3 study of its independently developed adalimumab biosimilar HLX03 in Chinese patients with psoriasis. The data was presented in an E-poster. The title of this study is “Efficacy, Safety and Immunogenicity of the Biosimilar HLX03 Compared with Adalimumab in Chinese Patients with Moderate to Severe Plaque Psoriasis: A Randomised, Double-blind, Phase 3 Equivalence Study”. Professor Jianzhong Zhang from Peking University People's Hospital, is the leading principle investigator of this study. It’s the first time that Henlius has released this Phase 3 study results. This study will help to accumulate more clinical evidence and experience of adalimumab biosimilar in this patient population.
HLX03 is an adalimumab biosimilar independently developed by Henlius in accordance with the "Technical Guidelines of Development and Evaluation of Biosimilar Drugs" to be used for the treatment of autoimmune diseases including psoriasis, rheumatoid arthritis and ankylosing spondylitis etc. Different from currently approved adalimumab biosimilars in China, the Phase 3 clinical trial of HLX03 was conducted among Chinese patients with psoriasis and provided valuable data for this population. The results show that the efficacy of HLX03 for moderate to severe plaque psoriasis is equivalent to that of the reference adalimumab injection, and it is also similar to the reference drug in terms of safety, immunogenicity and pharmacokinetics. As of now, the new drug application (NDA) for HLX03 was accepted by the National Medical Products Administration (NMPA), and was assigned to the priority review list by the NMPA. Recently, Henlius drug substance (DS) line and drug product (DP) line for the production of HLX03 has successfully passed the on-site inspection conducted by Shanghai Medical Products Administration. HLX03 is expected to be approved for launch by the end of 2020, which hopefully will benefit more patients with autoimmune diseases in China.
Study Design
HLX03-Ps03 is a multicentre, randomised, double-blind, parallel-controlled, phase 3 study (NCT03316781) comparing the efficacy, safety and immunogenicity of HLX03 with reference adalimumab in Chinese patients with moderate to severe plaque psoriasis. Enrolled patients were randomised (1:1) to receive either HLX03 or reference adalimumab by subcutaneous injection with an initial dose of 80 mg at Week 1 Day 1, followed by a dose of 40 mg at Week 2 Day 1, and then 40 mg every two weeks for up to Week 48. The primary endpoint was the percentage of improvement of Psoriasis Area and Severity Index at Week 16 (PASIwk16) relative to baseline.
Results
Efficacy
1）Primary Endpoint
262 patients were enrolled (HLX03, n = 132; Reference adalimumab, n = 130) in this study. Per FAS, the percentage improvement of PASIwk16 was 83.48% in HLX03 group and 82.02% in reference adalimumab group. The least square mean difference was 1.46% (95% CI: −3.86%, 6.79%), which fell entirely in the pre-defined equivalence margins (±15%), demonstrating equivalent efficacy between HLX03 and reference adalimumab.
2）Secondary Endpoints
There were no statistically significant differences between the treatment groups in secondary endpoints (including the percentage of subjects reaching an improvement of PASI by at least 75% relative to baseline, the percentage of improvement of PASI relative to baseline, the percentage of subjects with Physician’s Global Assessment [PGA] reaching clearance or close to clearance, and the change in Dermatology Life Quality Index [DLQI] relative to baseline) at weeks 4, 8, 12, 16, 20, 32, 50.
Safety and Immunogenicity
The safety and immunogenicity profiles were similar between HLX03 and reference adalimumab.
Conclusion
The results of the phase 3 study demonstrated the equivalence in efficacy between HLX03 and reference adalimumab with similar safety and immunogenicity profiles. HLX03 is expected to provide an alternative treatment option for patients with moderate to severe plaque psoriasis as an adalimumab biosimilar candidate.
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