Abstract
BackgroundABP 501 was evaluated in a phase 3 single-arm, open-label extension (OLE) study to collect additional safety and efficacy data in patients with rheumatoid arthritis (RA).MethodsSubjects completing the final visit in the parent phase 3 randomized, double-blind, controlled equivalence study comparing the efficacy and safety of the biosimilar ABP 501 with adalimumab reference product (RP) were enrolled in this open-label extension (OLE) study. All subjects received 40 mg ABP 501 every other week for 68 weeks. Key safety endpoints included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and anti-drug antibody (ADA) incidences. Efficacy endpoints included ACR20 (at least 20% improvement in American College of Rheumatology core set measurements from baseline) and Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP) change from baseline.ResultsAmong 466/467 patients treated with ABP 501, 229 transitioned from the ABP 501 arm of the parent study (ABP 501/ABP 501) and 237 from the adalimumab RP arm (RP/ABP 501); 412/467 (88.2%) patients completed the study. The overall TEAE incidence was 63.7% (297/466); grade ≥ 3 TEAE incidence was 9.0% (42/466). The incidence of TEAEs leading to discontinuation of investigational product was 3.6% (17/466). The SAE incidence was 9.9% (46/466). Overall, 18.2% (85/466) of subjects developed binding ADAs and 6.9% (32/466) developed neutralizing ADAs in the OLE study. The ACR20 response rate was 73.3% (340/464 subjects) at OLE baseline, and 78.8% (327/415 subjects) at week 70 of the OLE study. The overall mean DAS28-CRP change from the parent study baseline was − 2.25 at the OLE study baseline (n = 440), − 2.36 at week 4 (n = 463), − 2.41 at week 24 (n = 450), − 2.55 at week 48 (n = 433), and − 2.60 at week 70 (n = 412). Efficacy was maintained throughout the study.ConclusionsEfficacy previously demonstrated in the parent study was maintained in this OLE study with no new safety findings. Long-term safety, immunogenicity, and efficacy were similar in the ABP 501/ABP 501 and RP/ABP 501 groups. The single switch from RP to ABP 501 did not impact immunogenicity.Trial registrationClinicalTrial.gov, NCT02114931
Highlights
ABP 501 was evaluated in a phase 3 single-arm, open-label extension (OLE) study to collect additional safety and efficacy data in patients with rheumatoid arthritis (RA)
Statistical methods For the analysis of this single-arm OLE study, subjects were classified according to their treatment sequence across the parent study and the OLE study; subjects who had transitioned from adalimumab reference product (RP) in the parent study to ABP 501 in the OLE study are presented as “RP/ABP 501”, and those who remained on ABP 501 across both the parent study and the OLE study are presented as “ABP 501/ABP 501.”
The most common treatment-emergent adverse events (TEAEs) of interest was infection, which occurred in 101 (42.6%) patients who transitioned from adalimumab to ABP 501 and 89 (38.9%) patients who continued on ABP 501
Summary
ABP 501 was evaluated in a phase 3 single-arm, open-label extension (OLE) study to collect additional safety and efficacy data in patients with rheumatoid arthritis (RA). Biologics that neutralize tumor necrosis factor (TNF) are the newest DMARDs for which safety and efficacy have been demonstrated, but the use of these agents is cost-prohibitive [2]. To lower costs and improve patient access, regulatory agencies have established guidelines for the development of biosimilars, which are biologics that are highly similar to the originator reference product (RP). The expiration of patents on several biologics has spurred interest in biosimilar development [4]. Pharmacoeconomic analyses of biosimilars for RA have suggested that biosimilar use is associated with both significant cost savings and increased patient access to biologics [5, 6]
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