Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Abstract

Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn’s disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti–tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.

Adalimumab Biosimilar GP2017 versus Adalimumab Originator in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

“…Specifically, clinical remission was obtained in approximately 80% of patients overall, with no significant difference between GP2017 and ADA originator. Furthermore, 82.3% of patients treated with GP2017 obtained clinical remission, which agrees with data obtained in 81.8% (9 of 11) of IBD patients treated with GP2017 in a separate real-life Italian study [ 11 ].…”

“…GP2017 was approved for use in patients with IBD through extrapolation of indications. To date one study has determined that four ADA biosimilars, including GP2017, were efficacious and safe in treating IBD outpatients, comprising both biologic-naïve patients and those switched from the ADA originator, in a real-life Italian setting [ 11 ]. Hence, there is a paucity of data comparing the efficacy and safety of GP2017 with its originator ADA in IBD patients.…”

“…In Italy, ADA biosimilars are now approved to treat IBD. However, at present, real-life data on the efficacy and safety of the ADA biosimilars ABP501 (Amgevita TM , Amgen Inc., Thousand Oaks, CA, USA), SB5 (Imraldi TM , Samsung Bioepis UK Limited, Brentford, UK), MSB11022 (Idacio ® , Fresenius Kabi, Toronto, ON, Canada), and GP2017 (Hyrimoz TM , Sandoz GmbH, Holzkirchen, Germany) are currently limited [ 8 , 9 , 10 , 11 ].…”

“…The ADA biosimilar GP2017, was approved in January 2019 in Italy to treat patients with IBD [ 12 ]. Importantly, comparable efficacy and safety outcomes between GP2017 and three other biosimilars (SB5, APB501, and MSB11022) were identified in an Italian real-life observational study in IBD patients [ 11 ]. However, data comparing GP2017 and its ADA originator (Humira TM ) in IBD patients are lacking.…”

Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

“…Germany) [18][19][20][21]. In a previous study, we found no differences among these four ADA biosimilars in obtaining remission in UC and CD [22]. Since information about switching to ADA biosimilar is still limited, we aimed to compare the efficacy and safety of ADA biosimilars ABP 501 (Amgevita®), SB5 (Imraldi®), MSB11022 (Idacio®), and GP2017 (Hyrimoz®) in treating IBD patients in whom the replacement of the ADA originator to ADA biosimilars was made for a non-medical reason.…”