Post-hoc Analysis of Phase 3 Study Finds Significantly Lower Injection Site Reactions (ISR) and Injection Site Erythema (ISE) in Rheumatoid Arthritis (RA) Patients Receiving Etanercept Biosimilar YLB113 (Nepexto) It became clear. Reference product, etanercept. Her YLB113, a recombinant fusion protein tumor necrosis factor inhibitor (TNFi), showed long-term safety and sustained efficacy over 96 weeks, according to findings published in . International Journal of Rheumatic Diseases.1
“management [of RA] It requires long-term treatment with considerable cost burden,” the investigator noted. “Conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biologic DMARDs slow or halt the progression of joint destruction and deformity, but at an increased economic burden.”
In an open-label extension (OLE) single-arm study (YLB113-003), immunogenicity, safety, and efficacy, as well as the post-hoc incidence of ISR and ISE, the most common side effects of etanercept, were compared with Japanese RA. evaluated in patients. Patients who completed the final visit of a phase 3, double-blind, randomized, 96-week equivalence study. A patient with OLE was treated with either YLB113 50 mg or etanercept, whereas in the original study she was given YLB113 50 mg subcutaneously every two weeks. Both trials required a concurrent maintenance dose of methotrexate.
Endpoints were assessed by incidence of ISR, ISE, adverse events (AEs), physical examination, and anti-drug antibodies (ADA). Disease Active Pain 28 Joint Count (DAS28) assessments were performed at weeks 0 (baseline), 12, 24, 48, 72, and 96 to assess change from baseline.
Of the 201 patients initially included, 184 completed the study. Treatment-emergent AEs (TEAEs) were reported in his 93.5% (n = 188/201) of patients, and 10.4% experienced severe AEs. However, the discontinuation rate due to adverse events was only 2.0% (6 events) and most adverse events were rated as very mild or moderate. Serious side effects were noted in 7 of his cases (3.5%).
During the open-label extension period of the study, 20.0% of patients reported ISR, almost all of which were rated as mild. Two participants developed transient, non-neutralizing ADA. Results were similar to those observed in the Phase 3 trial. The change in DAS28 was 2.22 ± 0.95 at transitional baseline, 2.10 ± 0.91 at 72 weeks, and 2.06 ± 0.89 at 96 weeks. Scores remained low until the end of the study period.
Post hoc analysis showed that YLB113 had a significantly lower incidence of ISR (n = 10 [3.8%]P < 0.0001) and ISE (n = 5 [1.9%]P < 0.0001) when compared to etanercept (n = 35) [13.8%], P. < 0.0001 and n = 25 [9.8%], P. < 0.001, respectively).
The length of the study allowed researchers to analyze safety and efficacy data over 3 years. However, as this trial was conducted in Japan and included only Japanese patients, generalizability may be limited.
“This evidence indicates that YLB113 maintained a favorable safety, efficacy and immunogenicity profile over 3 years,” the researchers concluded. “The availability of Nepexto provides a safe and effective biosimilar that can positively impact the lives of patients.”
reference:
Hiroshi Yamanaka, Yoichi Tanaka, Takashi Hibino et al. Reduction of Injection Site Reactions and Long-Term Safety, Immunogenicity, and Efficacy of Etanercept Biosimilar YLB113: A Double-Blind, Randomized Phase III Comparison in Patients with Rheumatoid Arthritis Results of the post hoc analysis of the study and its open-label extension study. Int J Lumdis2023;26(1):108-115.doi:10.1111/1756-185X.14462
