The prospective adalimumab biosimilar CinnoRA was shown in a recently published phase 3 trial to be comparable to AbbVie’s innovator biological treatment Humira in terms of safety and efficacy in adult patients with active rheumatoid arthritis.
The prospective adalimumab biosimilar CinnoRA (under development by CinnaGen Co, based in Alborz, Iran) was shown in a recently published phase 3 trial to be comparable to AbbVie’s innovator biological treatment Humira in terms of safety and efficacy in adult patients with active rheumatoid arthritis (RA). The study, by Ahmadreza Jamshidi, MD, professor of internal medicine, Rheumatology Research Center at Tehran University of Medical Sciences, Tehran, Iran, and colleagues, was published online in Arthritis Research & Therapy and registered with the Iranian Registry of Clinical Trials.
This randomized, double-blind, active-controlled, noninferiority trial recruited 136 adult patients with active RA to receive 40 mg subcutaneous injections of either CinnoRA or Humira every other week while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a 24-week period. Physical examinations—including vital sign evaluations and laboratory testing—were conducted at baseline, 12 weeks, and 24 weeks. The 68 patients randomized to each arm of the study had comparable demographic information, lab results, and disease characteristics at baseline; 64 patients in each group completed the 24-week study period.
The study’s primary endpoint was the proportion of patients achieving a moderate or good disease activity score of 28 (based on the European League Against Rheumatism [EULAR] response rate) in terms of joints-erythrocyte sedimentation rate (DAS28-ESR). Secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses (measured as improvement in tender and swollen joint counts; patient assessments of pain, global disease activity, and physical function; physician global assessment of disease activity; and acute phase reactant), a disability index of health assessment questionnaire (HAQ), and safety.
The proportion of patients achieving good and moderate EULAR responses in the CinnoRA group was noninferior to the Humira group at 12 and 24 weeks, based on both intention-to-treat and per-protocol populations (all P values >.05). There were no significant differences in the proportion of patients achieving ACR20, ACR50, and ACR70 responses in the CinnoRA and Humira groups (all P values >.05).
The difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant, the researchers noted. Four patients withdrew from the CinnoRA group due to adverse drug reactions (ADRs; n = 2), a positive tuberculin test (n = 1), and poor compliance (n = 1). Similarly, 4 patients left the Humira group because of ADRs (n = 3) and poor compliance (n = 1). The researchers did not notice any significant difference in the incidence of injection site reactions as the most prevalent adverse events between treatment arms.