This article is more than 5 years old. Information may no longer be current.
Long-term efficacy, safety seen with SB4 in patients with rheumatoid arthritis
Click Here to Manage Email Alerts
During a 2-year study, SB4 was effective and well-tolerated in patients with rheumatoid arthritis and investigators found similar efficacy, safety and immunogenicity among patients who had extended treatment with SB4 compared with patients who switched from referenced etanercept to SB4.
“Switching from [the] originator to biosimilar is the key and commonest action with [biological disease-modifying antirheumatic drugs] bDMARDs/biosimilars. This is the first study of the longer-term outcomes of this switch,” Paul Emery, MA, MD, FRCP, arthritis research UK professor of rheumatology, director of Leeds Musculoskeletal Biomedical Research Unit, director of Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, told Healio Rheumatology. “Efficacy, safety and immunogenicity were comparable between individuals switching from originator to biosimilar compared to the continued biosimilar group. No risk was associated with switching patients from [etanercept] ETN to SB4.”
Patients with rheumatoid arthritis were randomized to receive subcutaneous SB4 (Benepali,Samsung Bioepis UK Limited; Brenzys, Samsung Bioepis) 50 mg or reference ETN 50 mg once a week for 52 weeks during a double-blind period. There were 245 patients from the Czech Republic and Poland who completed the 52-week study and were then enrolled in an open-label extension period. During the extension period, 126 patients received SB4 and 119 patients switched to SB4 for an additional 48 weeks. Patients were assessed up to week 100 for efficacy, safety and immunogenicity.
American College of Rheumatology (ACR) response rates were collected and were found to be similar between SB4/SB4 and ETN/SB4 groups. Investigators noted the ACR20 response rate at week 100 for the SB4/SB4 group was 77.9% and was 79.1% for the ETN/SB4 group. Radiographic progression was comparable between the two treatment groups at week 100.
The rate of treatment-emergent adverse events at 52 weeks for the SB4/SB4 group was 47.6% and was 48.7% for the ETN/SB4 group. In each treatment group, one patient developed non-neutralizing antidrug antibodies. None of the patients developed active tuberculosis or injection reactions. One patient in the SB4/SB4 group died from hepatic cancer. – by Monica Jaramillo
Disclosures: Emery reports he received funding for clinical research from Samsung Bioepis and received grant/research support from AbbVie and Pfizer; and consulting fees from AbbVie, Bristol-Myers Squibb, Pfizer, UCB, Merck Sharp & Dohme, Roche, Novartis, Takeda and Eli-Lilly. Please see the full study for a list of all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts