The biosimilar for adalimumab known as GP2017 is both safe and effective as a therapy for individuals with inflammatory bowel disease (IBD), according to recent findings, with a switch from the biosimilar or originator not demonstrating any influence on treatment outcomes.¹

These new findings resulted from a recent observational and retrospective study conducted to assess the efficacy and safety of GP2017 in a patient population with IBD. The new research was led by Cristina Bezzio, from the IBD Centre at the Gastroenterology Unit of Rho Hospital, ASST Rhodense in Italy.

Bezzio and colleagues noted that the research would also help to expand upon the limited amount of data that existed prior to their study regarding interchangeability and switches from originators to biosimilars and between different biosimilars such as adalimumab.²

“Particularly, we aimed to demonstrate our hypothesis that GP2017 has the same efficacy and safety of the adalimumab reference drug, both in patients naïve to adalimumab and in patients who switched from the originator or other biosimilars of adalimumab,” Bezzio and colleagues wrote.

Background and Findings

The research team used a retrospective, multi-center and observational design, conducting their research in Northern Italy at 2 IBD centers: Rho Hospital, ASST Rhodense, and Turin Hospital, Città della Salute e della Scienza, Italy. They involved subjects who had diagnoses of Crohn's disease or ulcerative colitis who had been given GP2017 therapy for 6 months minimum.

The team reviewed medical records from both of their centers, and all eligible study participants’ data were included in the new research. They defined subjects into 2 separate groups: individuals being given GP2017 as an initial adalimumab treatment and patients who switched to the drug from another adalimumab.

The investigators tracked the timing and rationale for subjects’ choices to switch. All of the study participants whose data were examined had received standard doses of the biosimilar. Information that the research team looked at from baseline included disease history, demographic data, manifestations which were extraintestinal, family history of IBD, and current and prior treatments.

The investigators looked at disease activity of the subjects at 3 distinct points in time: the beginning of their course of therapy (T0), at 6 months (T1), and at a year (T2). They used the Harvey–Bradshaw index (HBI) for individuals with CD and the partial Mayo (pMayo) for those with UC.

The research team determined 1 of their primary endpoints to be clinical remission at the 12-month mark for those starting GP2017 as their very first adalimumab. The other was maintenance of their remission at the 12-month mark for subjects switching to the biosimilar.

The investigators determined their secondary endpoints to include achievement of remission and maintenance at the 6-month mark, as well as therapy persistence, steroid-free remission, adverse events, and the effects of different factors on subjects’ remission and therapy optimization.

HBI < 5 for Crohn’s disease or pMayo < 2 for ulcerative colitis were considered to be clinical remission, and they defined steroid-free remission as remission that did not involve ongoing steroid treatment. Those who decided not to continue with therapy prior to the finish of their follow-up were viewed as non-responders.

In the end of the team’s research, they had looked at the data of 72 subjects in total. Among these, 65 had diagnoses of Crohn's disease and 7 had diagnoses of ulcerative colitis. Of the 29 individuals who had begun GP2017 therapy as their first adalimumab, the investigators reported that 58.6% were shown to have clinical remission.

For the 33 subjects who had had GP2017 as an originator or the 10 who switched from other biosimilars, the investigators found that clinical remission was shown to be maintained for 78.8% and 70%, respectively.

With regard to patients’ safety, only 11 of the subjects reported non-serious side effects. The research team noted that at the follow-up period, 9 individuals were shown to have discontinued their treatment mostly resulting from side effects or from secondary failure.

“Adalimumab GP2017 is an effective treatment in IBD in a real-world setting,” they wrote. “Moreover, the retention rate and safety profile are comparable to those present in the literature regarding the originator, justifying the feasibility to switch from the originator to a biosimilar or from biosimilar to biosimilar.”

References

1. ^{Vernero M, Bezzio C, Ribaldone DG, Costa S, Scalvini D, Tribocco E, Manes G, Saibeni S. Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease. Journal of Clinical Medicine. 2023; 12(21):6839. https://doi.org/10.3390/jcm12216839.}
2. ^{Allocati, E.; Godman, B.; Gobbi, M.; Garattini, S.; Banzi, R. Switching Among Biosimilars: A Review of Clinical Evidence. Front. Pharmacol. 2022, 13, 917814. [Google Scholar].}