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

Abstract

Background and Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason.
 Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars.
 Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6–24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild.
 Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.

Real‐world outcomes of switching from adalimumab originator to adalimumab biosimilar in patients with inflammatory bowel disease: The ADA‐SWITCH study

“…After a short follow‐up of only 10 weeks, no difference was found between both cohorts in terms of clinical activity 6 . Unlike our results, other authors have reported lower rates of clinical remission in patients who switched to ADA biosimilar 9,11,14,23 . In these studies, at least one third of patients had been exposed previously to anti‐TNF drugs, and in one of them, 11 not all the patients were in clinical remission at the time of switch.…”

“…6 Unlike our results, other authors have reported lower rates of clinical remission in patients who switched to ADA biosimilar. 9,11,14,23 In these studies, at least one third of patients had been exposed previously to anti-TNF drugs, and in one of them, 11 not all the patients were in clinical remission at the time of switch. These facts could probably have had an impact on the lower remission rates reported.…”

“…Other study reported that 6 of 9 patients who had clinical relapse after switching regained remission after switching back to ADA originator. 14 The reason for the response to switch back remains unknown. Some authors hypothesise that it may be related to an increase immunogenicity of ADA biosimilars.…”

“…All available data about the effectiveness and safety of this strategy are generated from real‐world studies, many of them with several limitations. In this sense, the majority of these studies have a retrospective design, have included a small number of patients, have a relatively short follow‐up period, and a lack of control group 6–15 …”

“…In this sense, the majority of these studies have a retrospective design, have included a small number of patients, have a relatively short follow-up period, and a lack of control group. [6][7][8][9][10][11][12][13][14][15] The aim of the present study was to compare the outcomes of ADA treatment over time in a large cohort of IBD patients who either maintained ADA originator or switched from ADA originator to different ADA biosimilars.…”