Background CHS-1420 is being developed as a proposed biosimilar to adalimumab for the treatment of rheumatoid arthritis, plaque psoriasis (PsO), and other auto-immune diseases.
Objectives This phase 3, randomized, double-blind, active-controlled, multicenter study evaluated the equivalence of CHS-1420 to adalimumab in patients with active, moderate-severe, chronic plaque PsO, including patients with psoriatic arthritis (PsA).
Methods Male and female patients (aged ≥18 years) were randomized to CHS-1420 or adalimumab. Patients received 40 mg x 2 on Day 0 and then 40 mg every other week (QOW) by subcutaneous injection. To establish the equivalence of CHS-1420 to adalimumab, the 95% CI of the treatment difference for the primary endpoint, PASI75 at Week 12, had to be within pre-specified equivalence margins of ±15%. The 55-week study is ongoing, and blinded efficacy data at Week 12 and safety data through Week 16 are available. The study was not powered for statistical analysis of the PsA subgroup. Patients with PsA were evaluated based on change in the Health Assessment Questionnaire – Disability Index (HAQ-DI) and highly sensitive C-reactive protein (hs-CRP).
Results The full analysis population for the primary efficacy endpoint consisted of 545 patients (mean age 43.9 years), with 274 and 271 in Group A and Group B, respectively. The mean BMI was 29.6 kg/m2, and 72.3% were male. At Week 12, the proportion of patients achieving a PASI75 from Baseline was 77.7% in Group A and 74.5% in Group B. The 95% CI of the treatment difference [-3.63, 10.28] was within the pre-specified equivalence margin [-15.0, 15.0]. Sensitivity analyses supported equivalence of the two treatments.
PsA was present in 65 (23.7%) and 61 (22.5%) patients in Group A and Group B, respectively. A PASI75 was achieved by 81.5% and 77.0% of patients with PsA in Group A and Group B, respectively, at Week 12. Mean HAQ-DI scores decreased from Baseline by 0.6 and 0.7 (95% CI: -0.3, 0.3) at Week 12 in Group A and Group B, respectively. Mean hs-CRP (mg/L) decreased from Baseline by 8.9 and 6.3 at Week 12 in Group A and Group B, respectively.
In the safety population (n=545), adverse events were reported in 48.5% and 45.0% of patients, in Group A and Group B, respectively, through Week 16. Serious adverse events were reported in 1.1% and 2.2% of patients in Group A and Group B, respectively, through Week 16, and none were judged by the investigator to be related to treatment. The most common (≥5% of patients) adverse events were nasopharyngitis and upper respiratory tract infection.
Conclusions This randomized, double-blind, global clinical trial demonstrated the equivalence of CHS-1420 to adalimumab in the treatment of chronic PsO. Both study drugs were well tolerated. Patients with PsA showed improvement with both study drugs.
Disclosure of Interest J. O'Dell Consultant for: Coherus BioSciences, A. Kivitz: None declared, K. Papp Consultant for: 3M, Abbott/AbbVie, Akesis, Akros, Allergan, Amgen, Alza, Anacor, Applied Molecular Evolution, Astellas, Baxter, Bayer, Boehringer Ingelheim, Celgene, Celtic, Centocor, Cipher, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Funxional Therapeutics, Galderma, Genentech, Genet, GSK, Isotechnika, Janssen, Janssen Biotech (Centocor), Kyowa Hakko Kirin, Merck, Merck-Serono, Novartis, Pfizer, C. Leonardi: None declared, K. Jensen Shareholder of: Coherus BioSciences, Employee of: Coherus BioSciences, H. Tang Shareholder of: Coherus BioSciences, Employee of: Coherus BioSciences, B. Finck Shareholder of: Coherus BioSciences, Employee of: Coherus BioSciences
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