No Clinical, Biochemical Changes Observed After Switch to Adalimumab Biosimilar for IBD

Findings from a recent study highlight the comparable safety and efficacy of the adalimumab biosimilar MSB11022 (Idacio) to its originator (Humira) in patients with inflammatory bowel disease (IBD), including Crohn disease and ulcerative colitis.¹

Results of the retrospective, observational study showed no significant differences in clinical disease activity, biochemical parameters, or safety profiles between the originator product and its biosimilar, based on assessments of patients who started directly on MSB11022 and those who switched from the adalimumab originator to MSB11022.¹

Initially approved by the US Food and Drug Administration for rheumatoid arthritis, adalimumab later received approval for Crohn disease in 2007 and ulcerative colitis in 2012.2 Since then, several biosimilar options have earned approval and are considered equivalent to the biologic reference adalimumab. However, their interchangeability in the setting of IBD remains contested.¹

“Randomized controlled trials comparing biosimilars with the originator adalimumab are unavailable, and few real-world studies have analyzed outcomes in IBD patients switched to a biosimilar,” Jaime Poquet-Jornet, of the Hospital of Denia in Spain, and colleagues wrote.¹ “No studies to date have analyzed efficacy and safety outcomes in IBD biologic-naïve patients started on adalimumab MSB11022 or in IBD patients switched from originator adalimumab to adalimumab MSB11022.”

To address this gap in research, investigators performed a retrospective, observational study in a real-life cohort of adult patients with IBD. Data were collected from the Cerner Millennium electronic health record platform for patients diagnosed with IBD according to the European Crohn's and Colitis Organization criteria who were ≥ 18 years of age and receiving ongoing treatment with the adalimumab originator and/or biosimilar for ≥ 3 months in the non-switch cohorts and > 6 months in the switch cohort.¹

In total, 44 patients were retrospectively enrolled in the study. Among the cohort, 30 patients were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab.¹

Given the lack of a gold-standard approach for assessing clinical response to anti-TNF agents in IBD and the prevalence of clinical manifestations that do not always correlate with objective assessments of disease activity, treatment effectiveness was assessed using a combination of clinical and biochemical data. Specifically, investigators assessed biosimilar effectiveness by comparing fecal calprotectin and C-reactive protein at baseline and after the switch, defining clinical remission as an HBI < 4 for Crohn disease and a partial Mayo score ≤ 1 for ulcerative colitis.¹

Treatment failure, on the other hand, was defined as meaningful clinical and biochemical differences compared with the originator, need for dose intensification, need for concomitant treatment with corticosteroids or thiopurines, switch to another biologic, and IBD-related hospitalization, surgery, and/or ER visits. Safety was assessed by analyzing treatment interruptions and adverse events.¹

No statistically significant differences were observed between the originator adalimumab and biosimilar adalimumab MSB11022 start cohorts regarding age, gender, disease duration, disease behavior, tobacco smoking, concomitant therapy, and clinical characteristics. The only significant difference investigators observed was a longer treatment duration in the originator adalimumab cohort (63 months vs 6 months; P = .001).¹

Similarly, no statistically significant differences were observed between the originator adalimumab and switch cohorts for age, gender, disease duration, disease behavior, tobacco smoking, and clinical findings regarding fecal calprotectin, C-reactive protein, and disease index. However, significant differences were noted between the originator cohort and the switch cohort for use of thiopurines (12 vs 0; P = .036) and treatment duration (63 vs 4 months; P <.001).¹

Further analysis showed no significant differences in clinical disease activity (P = .317) or biochemical parameters (fecal calprotectin, P = .445 and C-reactive protein, P = .661) after patients switched from the originator adalimumab to MSB11022. Investigators additionally noted the effectiveness analysis showed no significant differences between the originator adalimumab cohort and the biosimilar adalimumab MSB11022 start cohort. However, there was a trend towards higher C-reactive protein levels in the originator cohort compared with the switch cohort (2.1 vs 0.7; P = .079).¹

No differences were observed for treatment discontinuation in the originator and biosimilar start groups (P = .647). Investigators pointed out 3 patients in the biosimilar adalimumab MSB11022 start cohort and 8 patients in the originator adalimumab group experienced adverse events, with 1 patient discontinuing treatment in each. In the switch cohort, 1 patient discontinued adalimumab treatment due to a loss of response after the switch.¹

Investigators highlighted different sizes of cohorts as well as the lack of endoscopic monitoring and data regarding therapeutic drug monitoring as potential limitations to the study, but still concluded: “This study provides valuable data on short-term responses and reflects real-world practice with adalimumab biosimilar MSB11022 treatment"

References:

1. ^{Poquet-Jornet JE, Ibáñez-Sala I, Garrigues-Pelufo T, et al. Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease. Farmacia Hospitalaria. https://doi.org/10.1016/j.farma.2024.01.002}
2. ^{Stewart, J. Humira FDA Approval History. Drugs.com. August 25, 2022. Accessed April 8, 2024. https://www.drugs.com/history/humira.html}