Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases

Abstract

Objective SB5 showed comparable efficacy and safety profile in respect to adalimumab originator (ADA) in randomized clinical trials of rheumatoid arthritis (RA) and psoriasis. We aimed to describe the efficacy and safety of SB5 after switching from ADA in RA, axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and juvenile idiopathic arthritis (JIA) patients. Method Adult RA, PsA, axSpA, JIA patients treated with ADA for at least 6 months, switched to SB5 in stable clinical conditions, were eligible. Data on safety, activity indexes and patient-reported outcomes were collected at baseline, 3 and 6 months after switching. Results Eighty-two patients (19 RA, 28 PsA, 32 axSpA and 3 JIA; 45 females, mean age 54 ± 14 years, disease duration 13 ± 7 years, ADA duration 6 ± 3 years) were enrolled. RA patients showed stable conditions, while PsA patients showed an increase in both HAQ, DAS28(CRP) and DAPSA and axSpA patients an increase in VAS pain, VAS patient disease activity and ASDAS, both at 3 months. There were changes in the concomitant medications profile, with regression of activity indexes increases at 6 months. Adverse events were reported by 33.7% patients at 3 months and 16.6% patients at 6 months, mostly disease flares and infectious events. Two patients stopped SB5. Conclusions Despite temporary changes in the concomitant medication profile for mild disease flares, our real-life data replicate the safety profile of switching from ADA to SB5 in RA, with additional data for its applicability in PsA and axSpA patients, further supporting switching to biosimilars in treating inflammatory rheumatic conditions. Key Points• Switching from adalimumab originator to SB5 is feasible in real life rheumatic inflammatory joint diseases.• Mild disease flares can present after switching from originator adalimumab to SB5, in particular in axial spondyloarthritis and psoriatic arthritis.• Changes in concomitant medications profile allows the control of minor disease flares presenting after switching from adalimumab originator to SB5.

Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

“…No serious TEAEs were recorded. 28 In PSO patients, Hercogová et al reported that the incidence of TEAEs, serious TEAEs, treatment discontinuations due to TEAEs, injection site reactions, and hypersensitivity reactions were comparable in the three treatment arms through to week 66. 30 Blauvelt et al did not find any relevant differences with respect 7.6%, and R-B: 9.1%).…”

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

“…SB5 was approved by the EMA and FDA in 2017 and 2019, respectively, and was proven to have s similar structure, function, and PK to ADL (17,18). Weinblatt et al (17,19) phase III, randomized, double-blind, parallel group study comparing SB5 with ADL in efficacy, safety, and immunogenicity included 544 moderate to severe RA patients, despite MTX treatment.…”

Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

“… 8 , 9 Switching from ADA to SB5 was demonstrated not to impact the efficacy and immunogenic profile of RA patients, 9 and short-term real-life data confirmed efficacy and results in inflammatory bowel diseases (IBD), plaque psoriasis, PsA patients switched to SB5, as well as in mixed cohorts of iRMD. 10 – 12 …”