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In
patients with inflammatory rheumatic conditions, switching from reference ADA
(adalimumab originator) to SB5 (biosimilar of ADA) is feasible.
In a recent study, switching from ADA to SB5 was found to be feasible in patients with rheumatic inflammatory joint diseases such as axSpA (axial spondyloarthritis), PsA (psoriatic arthritis) and JIA (juvenile idiopathic arthritis).
In randomized trials of RA (rheumatoid arthritis) and psoriasis, SB5 has illustrated comparable safety and efficacy profiles when compared to ADA. This retro-prospective observational study aimed to describe the safety and efficacy of switching from reference ADA to SB5 in a real-life cohort of patients with clinically stable inflammatory RMDs (rheumatic musculoskeletal diseases) such as RA, axSpA, PsA, and JIA.
From October 2018 to November 2019, the study recruited adult RA, PsA, axSpA, JIA participants administered with ADA for at least 6 months that switched to SB5 in stable clinical conditions. At baseline, 3 and 6 months after switching, data on safety, activity indexes, and patient-reported outcomes were collected.
During the observation period, a total of 115 patients were switched from reference ADA to SB5. Overall, a total of 82 subjects (19 RA, 32 axSpA, 28 PsA, and 3 JIA; 45 females, mean disease duration:13 ±7 years, mean age: 54 ± 14 years, ADA duration 6 ± 3 years) were found to be eligible for this analysis.
Stable conditions were witnessed in RA patients. PsA patients demonstrated an elevation in both HAQ (health assessment questionnaire), DAS28CRP (disease activity score calculated with C-reactive protein), and DAPSA (disease activity in psoriatic arthritis). axSpA patients illustrated an elevation in VAS pain (patient visual analogic scale for pain), VAS patient disease activity, and ASDAS (Ankylosing Spondylitis disease activity score), both at 3 months.
Alterations in the concomitant medications profile and regression of activity indexes increases at 6 months were found to occur. Overall, 33.7% of patients reported adverse events at 3 months. While, 16.6% of patients reported adverse events at 6 months (mostly infectious events and disease flares). About two patients stopped SB5 as depicted in Table 1:
Changes in concomitant medications profile
enable the control of mild disease flares presenting after switching from
ADA to SB5. Mild disease flares can
occur after switching from ADA to SB5, specifically in axSpA and PsA
individuals. Thus, in real life rheumatic inflammatory joint disorders,
switching from ADA to SB5 is feasible.
Clinical Rheumatology
Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases
Cosimo Bruni et al.
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