SPOSAB ABP 501: A Sicilian Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Adalimumab Biosimilar ABP 501

Abstract

Background and Aim There are few clinical data on Adalimumab (ADA) biosimilars in inflammatory bowel disease. We aimed to perform a multicenter, observational, prospective study on safety and effectiveness of ADA biosimilar ABP 501 in patients with inflammatory bowel disease. Methods All consecutive patients from the cohort of the Sicilian Network for Inflammatory Bowel Disease treated with ADA biosimilar ABP 501 from February 2019 to February 2020 were enrolled. Patients were divided into three groups: group A, naïve to ADA and naïve to anti‐tumor necrosis factors; group B, naïve to ADA and previously exposed to anti‐tumor necrosis factors; and group C: switched from ADA originator to ABP 501. Results A total of 559 patients (median age 39 years; Crohn's disease 88.0%, ulcerative colitis 12.0%) were included, with a follow‐up time of 403.4 patient‐years. Thirty‐six serious adverse events occurred in 36 patients (6.4%; incidence rate [IR]: 8.9 per 100 person‐years [PY]). The IR of serious adverse events was higher among patients in group A compared with group C (17.4 vs 4.8 per 100 PY; IR ratio = 3.61; P < 0.001) and among patients in group B compared with group C (16.4 vs 4.8 per 100 PY; IR ratio = 3.42; P = 0.041). Among ADA‐naïve patients (group A + B), 188 (85.8%) had a clinical response after 12 weeks, including 165 (75.3%) who achieved steroid‐free remission. Higher treatment persistence estimates were reported for patients in group C compared with groups A and B (log–rank P < 0.001). Conclusions Safety and effectiveness of ABP 501 seem to be overall similar to those reported for ADA originator. Switching from originator to ABP 501 was safe and effective.

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

“…Drug retention was considered an end‐point of effectiveness in some of the switching studies 31,35–37 . Similar retention rates were demonstrated in patients after switching.…”

“…Thirty‐six (6.4%) serious adverse events occurred in this study. The incidence rate of serious adverse events was higher among patients in the naïve anti‐TNF group compared to the switching group (17.4 vs 4.8 per 100 person‐years; P < .001) and among patients in the naïve adalimumab group compared to the switching group (16.4 vs 4.8 per 100 person‐years; P = .041) 36 …”

“…The incidence rate of serious adverse events was higher among patients in the naïve anti-TNF group compared to the switching group (17.4 vs 4.8 per 100 person-years; P < .001) and among patients in the naïve adalimumab group compared to the switching group (16.4 vs 4.8 per 100 person-years; P = .041). 36 Cingolani et al recorded TEAEs which led to discontinuation of therapy. One patient who switched to ABP501 and one patient who switched to SB5 needed to stop therapy due to TEAEs.…”

How to Choose the Biologic Therapy in a Bio-naïve Patient with Inflammatory Bowel Disease

“…In a Sicilian study of IBD patients treated with ADA biosimilar, including anti-TNFnaïve and previous exposure patients, efficacy and safety of ADA biosimilar did not differ from the original [153]. The efficacy of ADA biosimilar has also been demonstrated in other studies including UC and CD [154,155].…”

Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis

“…In observational registries, the retention rate is considered a reliable indicator of treatment effectiveness since it is committed to drug efficacy and safety. To date, only few real-world data have been published concerning the use of ABP 501, mainly in the context of inflammatory bowel diseases and psoriasis [ 9 , 10 , 11 , 12 , 13 ]. With the exclusion of these reports, no other data on ABP 501 use in both reference product-naive and experienced inflammatory arthritides patients are available.…”