Equivalence of SB5 and adalimumab established in patients with RA
medwireNews: Results of a phase III trial suggest that the adalimumab biosimilar SB5 has equivalent efficacy, safety, and immunogenicity profiles to its reference product in patients with moderate-to-severe rheumatoid arthritis (RA) despite methotrexate treatment.
The researchers found that a comparable proportion of the 239 patients who were randomly assigned to receive SB5 and the 237 receiving adalimumab achieved at least a 20% improvement in ACR criteria (ACR20) after 24 weeks of treatment, at 72.4% versus 72.2%.
Patients in the two groups also had similar ACR50 and ACR70 response rates, as well as a comparable incidence of antidrug antibodies, and the treatment-emergent adverse events were “as expected for the population and drug class,” report Michael Weinblatt (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and co-authors.
“Patient age had no notable effect on the efficacy results, which is consistent with previous findings showing that the efficacy of DMARD therapy in elderly patients with RA was comparable with that in younger patients,” write the researchers in Arthritis & Rheumatology.
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