Similar efficacy, safety profile seen for SB5 biosimilar, adalimumab in patients with RA

Patients with rheumatoid arthritis who received the biosimilar to adalimumab called SB5, developed by Samsung Bioepis, showed similar treatment effects compared to patients who received the originator adalimumab, according to the results of a phase 3 trial.

A group of 544 patients with moderate-to-severe rheumatoid arthritis (RA) were randomized to receive 40 mg of either SB5 (adalimumab, Samsung Bioepis) or originator adalimumab (Humira, AbbVie) for 24 weeks. At that time, patients who did not receive SB5 were randomized to either SB5 or originator adalimumab for an additional 28 weeks while patients who received SB5 at initiation continued to receive SB5.

At week 24, the ACR20 response rate was 72.5% in patients who received SB5 and 72% in patients who received originator adalimumab. Full analysis, including non-responders, showed a similar rate of ACR20 response. An ACR50 response was observed in 38.3% of patients who received SB5 compared to 39.8% of patients who received the originator product at week 24. An ACR70 response was met by 19.2% of patients who received SB5 compared to 20.3% of patients who received originator adalimumab. At week 24, antidrug antibodies were present in 32.8% of patients who received SB5 and in 31.7% of patients in the originator group.

The safety profile was similar between patients, with reports of adverse events from 96 patients of the 268 patients who received SB5 and 110 patients of 273 patients who received the originator adalimumab. At least one serious adverse event was reported by 3 patients who received SB5 and by 7 patients who received the originator. Serious infections were identified in 1 patient who received SB5 and in 2 patients who received the originator. Injection site reactions occurred in 8 patients in each of the groups. No malignancies or deaths were reported in the SB5 group and two malignancies and two deaths were reported in the originator group. No cases of tuberculosis developed in either group. – by Shirley Pulawski

Reference:

Weinblatt ME, et al. Paper #8L. Presented at: American College of Rheumatology Annual Meeting; Nov. 7-11, 2015; San Francisco.

Disclosure: Weinblatt reports financial agreements with Samsung Bioepis, Merck, AbbVie, Amgen, Pfizer, Bristol Myers Squibb, Novartis, Roche and UCB. Please see the full study for a list of all other authors’ relevant financial disclosures.