FROM ANNALS OF THE RHEUMATIC DISEASES
The biosimilar ABP 501 is equally as effective and safe as adalimumab for the treatment of moderate to severe rheumatoid arthritis, according to results of a phase III clinical trial.
In a randomized, double-blind equivalence study across 100 medical centers in 12 countries, 526 patients with moderate to severe RA and inadequate response to methotrexate received either ABP 501 or adalimumab. Of the 526, 494 completed the study. Just over 80% of patients were women, and 95.1% were white, with a mean age of 55.9 years. Patients received either 40-mg ABP 501 or adalimumab subcutaneously on day 1 and every 2 weeks until week 22, with primary endpoint assessments conducted after 24 weeks, according to Dr. Stanley Cohen and his associates (Ann Rheum Dis. 2017 Jun 5. doi: 10.1136/annrheumdis-2016-210459 ).
Achievement of American College of Rheumatology 20 (ACR 20) response goals was similar across both groups after 24 weeks, with 74.6% of the ABP 501 group and 72.4% of the adalimumab group achieving stated ACR 20 response criteria, with a risk ratio of 1.039 for ABP 501, compared with adalimumab. Changes from baseline were similar in Disease Activity Score 28-joint count–C reactive protein, ACR 50, and ACR 70 for both groups as well.
Treatment-emergent adverse events occurred in 132 of the 264 patients in the ABP 501 group and in 143 of the 262 patients in the adalimumab group. Common treatment-emergent adverse events in both groups included nasopharyngitis, headache, arthralgia, cough, and upper respiratory infection. Serious adverse events occurred in 10 patients who received ABP 501 and in 13 patients who received adalimumab. Sepsis was the only serious adverse event that occurred in more than one patient.
Over the course of the study, 38.3% of patients who received ABP 501 and 38.2% of patients who received adalimumab tested positive for binding antidrug antibodies.
The study data “contribute to the totality-of-evidence–based requirements to demonstrate that ABP 501 is similar to adalimumab. The FDA has, thus, approved ABP 501 for use as a biosimilar to adalimumab, making it a valuable new therapeutic option for the treatment of moderate to severe RA,” Dr. Cohen and his associates concluded.
The study was funded by Amgen. Dr. Cohen and five of his associates reported conflicts of interest. Two investigators are employees of Amgen.
