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

Abstract

Summary Background and Aims Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar. Methods Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non‐switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC). Clinical remission was defined as a Harvey–Bradshaw index ≤4 in Crohn's disease and a partial Mayo score ≤2 in ulcerative colitis. To control possible confounding effects on treatment discontinuation, an inverse probability treatment weighted proportional hazard Cox regression was performed. Results Five hundred and twenty‐four patients were included: 211 in the SC and 313 in the NSC. The median follow‐up was 13 months in the SC and 24 months in the NSC (p < 0.001). The incidence rate of ADA discontinuation was 8% and 7% per patient‐year in the SC and in the NSC, respectively (p > 0.05). In the multivariate analysis, switching from ADA originator to ADA biosimilar was not associated with therapy discontinuation. The incidence rate of relapse was 8% per patient‐year in the SC and 6% per patient‐year in the NSC (p > 0.05). Six percent of the patients had adverse events in the SC vs. 5% in the NSC (p > 0.05). Conclusion Switching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator.

Trends in Targeted Therapy Usage in Inflammatory Bowel Disease: TRENDY Study of ENEIDA

“…Despite an initial reticence to use biosimilars, these compounds have gained prominence, and mounting evidence supports their use in clinical practice, as well as the switch to their use in patients who start on the original drug [33,34]. Moreover, their introduction in IBD treatment is expected to reduce the economic burden on healthcare systems [35].…”

Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study

“…Relatively few real-life studies have investigated the switch to adalimumab biosimilars [11][12][13][14][15][16][17][18][19][20], and a majority of these studies have not included a comparison group of patients receiving the original treatment. The present study was aimed to address this research gap by comparing the time of persistence between adalimumab biosimilars and the reference drug in a cohort of patients, including a mixed group that made the switch from the originator to the biosimilar.…”

Drug survival and safety of biosimilars and originator adalimumab in the treatment of psoriasis: a multinational cohort study

“…4 In previous real-world comparative studies, no significant differences in drug retention, effectiveness and safety were found between biosimilars and Humira for inflammatory bowel diseases and rheumatic diseases. [5][6][7][8] However, studies investigating hidradenitis suppurativa treatment have suggested that switching from the originator to biosimilars was associated with increased risks of ineffectiveness and treatment discontinuation. 9 10 For the treatment of psoriasis, evidence is predominantly derived from short clinical trials, with only one small real-world study comparing biosimilars to Humira.…”