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Adalimumab biosimilar safe, effective in RA
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Patients with rheumatoid arthritis who were treated with SB5, an adalimumab biosimilar, demonstrated a comparable response rate to those who received adalimumab, as judged by the American College of Rheumatology 20% improvement criteria, according to findings published in Arthritis and Rheumatology.
“Several biologic disease-modifying antirheumatic drugs targeted against tumor necrosis factor, such as adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, have been developed and approved for use worldwide in patients with [RA] and have yielded very positive clinical outcomes,” Michael R. Weinblatt, MD, of Brigham and Women’s Hospital, Boston, and colleagues wrote. “The use of [tumor necrosis factor] inhibitors in combination therapy for the treatment of RA is recommended by [EULAR] and [ACR].”
To determine the efficacy, pharmacokinetics, safety and immunogenicity of SB5, compared to adalimumab, the researchers conducted a phase 3, randomized, double-blind, parallel-group trial among patients with moderate-to-severe RA.
The full analysis included 542 participants assigned to either SB5 (n = 269) or adalimumab (n = 273). In addition, the per-protocol set included 476 patients: 239 who received SB5 and 237 who received adalimumab. Patients in both groups received a 40-mg dose, administered subcutaneously every other week. The primary endpoint for efficacy was the response rate as judged by the ACR20 improvement criteria at week 24 in the per-protocol set.
According to the researchers, the per-protocol group’s response rates were equivalent between those treated with SB5 and those who received adalimumab — 72.4% vs. 72.2%, respectively — with similar results reported in the full analysis set. The groups were also comparable across other endpoints, including the ACR 50% improvement criteria and ACR 70% response rates. The researchers’ subgroup analyses demonstrated that the efficacy and safety of SB5 was comparable to adalimumab, regardless of antidrug antibody status.
“The findings from this phase 3 multicenter, randomized, double-blind, parallel-group study showed equivalent efficacy between SB5 and the [adalimumab] reference product, as demonstrated by the ACR20 response rates at week 24 and other secondary efficacy end points at week 24,” Weinblatt and colleagues wrote. “SB5 was well-tolerated and possessed [pharmacokinetics], safety and immunogenicity profiles comparable to those of the reference [adalimumab].” – by Jason Laday
Disclosure: Weinblatt reports receiving consulting fees from and/or honoraria from AbbVie, Amgen, Novartis, Roche, GlaxoSmithKline, Merck, Samsung, Crescendo Bioscience, AstraZeneca, Bristol-Myers Squibb, Lilly, Pfizer and UCB, as well as research funding from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Sanofi and UCB. See the full study for additional authors’ disclosures.
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