Norwegian Study Finds Nonmedical Switch to Biosimilar Etanercept SB4 Well Tolerated in RA

Jackie Syrop

A preliminary study among patients with rheumatoid arthritis (RA) in Norway who were switched from originator etanercept to its biosimilar (SB4) for nonmedical reasons found that patients had good tolerance for the switch to the biosimilar, with no impairment in disease measures.

Norwegian rheumatologists are encouraged to prescribe the lowest-cost biologic disease-modifying antirheumatic drug (DMARD), which in turn encourages nonmedical switches. A preliminary study among patients with rheumatoid arthritis (RA) in Norway who were switched from originator etanercept (Amgen’s Enbrel) to its biosimilar (SB4, Samsung Bioepis’ Benepali) for nonmedical reasons found that patients had good tolerance for the switch to the biosimilar, with no impairment in disease measures.

“In patients who stopped the biosimilar because of lack of effect, only a minor numerical increase in disease measures was seen,” the researchers concluded. They noted, however, that their promising preliminary results need confirmation via a large-scale study.

The current study was presented by Glenn Haugeberg, MD, PhD, and colleagues at the annual European Congress of Rheumatology, held June 13-16, 2018, in Amsterdam.

The multicenter clinical study followed 191 patients with RA (mean age, 60.8 years; 67% female) who underwent a nonmedical switch from originator to SB4. Mean observation time for the 163 patients still on the biosimilar etanercept was 1.23 years. A total of 28 patients (14.7%) stopped treatment.

Among these patients, the mean observation time for the 7 (3.7%) patients in remission was 0.53 years; for the 10 patients (5.2%) reporting adverse events (AEs), 0.44 years; and for the 11 patients (5.8%) reporting lack or loss of efficacy, 0.44 years.

For all 191 patients, no significant change from baseline to last observation was seen for Disease Activity Score 28 (DAS28) [2.1 (1.5-2.8) vs 1.9 (1.5-2.5); P = .33], modified Health Assessment Questionnaire [mHAQ: 0.3 (0.0-0.7) vs 0.4 (0.1-0.6); P = .62], and patient Visual Analogue Scale (VAS) global [20.0 (10.0-43.0) vs 25.0 (10.0-43.3) mm; P = .73). C-reactive protein (CRP) improved significantly during follow up [2.0 (1.0-5.0) vs 1.0 (1.0-5.5) mg/dL; P = .02]. For the subgroup of patients who stopped treatment because of lack of efficacy, a minor nonsignificant impairment was observed for DAS28 [2.0 (1.4-2.5) vs 2.6 (1.2-4.0); P = .32], CRP [0.0 (0.0-6.0) vs 3.5 (0.8-13.3) mg/dL; P = .66), mHAQ [0.1 (0.0-0.1) vs 0.5 (0.3-0.5); P = .66], and patient VAS global [20.0 (10.0-30.0) vs 29.0 (17.0-58.5) mm; P = .66].

AEs reported were: chest pain (1 patient), neuropathy (1 patient), gastrointestinal reaction (1 patient, visual impairment (1 patient), infection (1 patient), joint stiffness (2 patients; 1 went back on etanercept), and skin reactions (3 patients). The researchers noted that it remains to be studied whether the reported AEs were associated with the switch from originator to the biosimilar.

Reference

Haugeberg G, Bakland G, Rodevand E, et al. Drug survival and reason for drop-out in rheumatoid arthritis patients with a non-medical switch from originator etanercept to biosimilar etanercept—preliminary data from a Norwegian multicenter study. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract AB0441. doi: 10.1136/annrheumdis-2018-eular.4716.