Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD

A real-world study conducted in Spain on patients with inflammatory bowel disease (IBD) receiving either the adalimumab originator or biosimilar MSB11022 (Idacio; Fresenius Kabi) found “no meaningful changes” in in clinical or biochemical markers of disease activity following a switch to the biosimilar, and no differences in effectiveness between the reference product and biosimilar in adalimumab-naive patients.

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Crohn disease (CD) and ulcerative colitis (UC) are collectively known as IBD and are chronic, immune-mediated inflammatory diseases of the digestive tract. The authors commented that IBD prognosis has been “greatly improved” by biologic therapy, particularly monoclonal antibodies targeting tumor necrosis factor (TNF)-α. The adalimumab originator was first approved in 2002, “and rapidly became the backbone therapy for moderate to severe IBD.” However, biologic therapy for IBD “places a significant financial burden on healthcare systems” which limits patient access to appropriate treatment, they said.

The adalimumab biosimilar MSB11022 (Idacio or adalimumab-aacf)was approved for use in the EU in 2019 and US in 2022, based on a comparative clinical trial in moderate to severe chronic plaque psoriasis. According to the authors, data on effectiveness and safety of MSB11022 in IBD are “scarce.” They assessed effectiveness and safety of MSB11022 in both adalimumab-naïve and switched patients compared to those continually treated with the reference product. The retrospective, observational study included 44 patients with IBD at a single medical center in Spain: 30 were treated with the reference product only, 5 began treatment with the biosimilar, and 9 switched from the reference product to the biosimilar. Effectiveness was assessed by laboratory markers fecal calprotectin and C-reactive protein (CRP) and by disease severity scales Harvey-Bradshaw Index (HBI) for CD and Mayo Score for UC. Adverse events (AEs), concomitant therapies, and need for dose intensification were also reported.

Comparing the 30 patients in the reference product cohort and the 5 in the biosimilar-start cohort, baseline demographic and clinical characteristics were not significantly different, except for longer treatment duration in the reference product cohort (63 vs 6 months). There were no significant differences in the proportion of patients who discontinued treatment. One patient in the reference product group required hospitalization, and 3 of the 5 patients in the biosimilar cohort experienced AEs. Two of the 3 had musculoskeletal pain; the other patient had hair loss and skin rash and discontinued treatment. Eight of the 30 patients treated with the reference product experienced AEs, which included hypertransaminasemia, periocular rash, bone fracture, musculoskeletal pain, herpes zoster, blurry vision, headache, cataract formation, and body tremors. One patient in the reference product group discontinued treatment due to cataract formation.

Comparing the 30 patients in the reference cohort to the 9 who switched to MSB11022, there were no significant differences in most demographic and clinical characteristics including age, gender, disease duration, fecal calprotectin, and CRP. Twelve patients in the originator group also received thiopurines compared to zero in the switch group, and treatment duration was significantly longer in the originator group (63 vs 4 months). The authors also noted trends toward higher CRP levels and more IBD-related emergency room visits in the originator group that were not statistically significant.

For the 9 patients who switched from the reference product to the biosimilar, effectiveness indicators were compared before and after the switch. Treatment duration was longer prior to the switch compared to after (93 vs 4 months), and use of corticosteroids and thiopurines decreased after the switch, but the difference was not statistically significant. There were no significant differences in clinical disease activity or biochemical markers before and after switching. Two of the 9 patients experienced AEs after switching (hypertransaminasemia and musculoskeletal pain) but neither discontinued treatment, and none of the patients required hospitalization or surgery. One patient, who had moderate disease activity at the time of the switch and had been treated with multiple biologics including other anti-TNF agents previously, discontinued treatment due to loss of response after switching.

The investigators said their findings demonstrated no changes in clinical or biochemical indicators of disease activity in patients who switched from the adalimumab originator to MSB11022, and that the biosimilar was safe and effective in adalimumab-naïve patients with IBD in a real-world setting. They added that to their knowledge, theirs is the first Spanish study to analyze effectiveness and safety in patients with IBD started on this adalimumab biosimilar and switched from the originator.

Reference

Poquet-Jornet JE, Ibáñez-Sala I, Garrigues-Pelufo T, Munilla-Das A, Valdivia-Pérez A, Carrera-Hueso FJ. Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease. Farm Hosp. Published online April 2, 2024. doi:10.1016/j.farma.2024.01.002