Switches to Adalimumab Biosimilars Yielded Similar Outcomes to the Reference Product in IBD

Patients with inflammatory bowel disease (IBD) experienced similar safety and efficacy outcomes when they were switched to 1 of 2 adalimumab biosimilars from the reference product, according to a recent study published in Scientific Reports.

“Overall, biosimilar drugs seem to be as effective and safe as the originator. Further larger and longer studies are mandatory to understand the clinical implications of these findings,” wrote the investigators.

The study set out to verify the clinical outcomes of biosimilars ABP501 (Amgevita) and SB5 (Imraldi), which have been approved by the European Medicines Agency for all indications of the reference product (Humira). However, some of the indications were extrapolated based on data from trials on patients with rheumatic diseases, suggesting that more real-world evidence is needed to confirm the effects in IBD specifically.

“Indeed, while we have significantly reduced the healthcare costs related to IBD treatments thanks to the adoption of these molecules, it is relevant to acknowledge that this was done without a consistent literature supporting their efficacy and safety in the gastroenterological field,” wrote the investigators.

IBD is an umbrella term for ulcerative colitis and Crohn disease (CD). IBD is often treated with anti-tumor necrosis factor-alpha drugs, such as adalimumab, which can help patients control flares, prevent complications, and stall disease progression.

The multicenter prospective cohort study enrolled patients from the IBD Unit of Padua University and 3 IBD centers in Santorso, Pisa, and Genoa, Italy and was conducted between October 2018 and July 2020.

Eighty patients with IBD who originally received reference adalimumab were enrolled in the study and were switched to receive either ABP501 (n = 55) or SB5 (n = 25). Switched patients were age- and sex-matched with 38 patients, who acted as a control group and continued to receive reference adalimumab for at least 2 years without switching to a biosimilar. Data was collected at baseline and at 6 months after switching.

Among the patients who were switched to ABP501, 45 (81.8%) had CD and 35 (63.6%) were men. At baseline, 47 (85.5%) patients were in remission, 5 (9.1%) had mild disease, 3 (5.4%) has moderate disease, and none had severe disease.

After 6 months, 42 (76.4%) were still in remission, 4 (7.3%) had mild disease, 8 (14.5%) had moderate disease, and 1 (1.8%) had severe disease (baseline vs 6 months post-switch; P = .09).

For the patients who were switched to SB5, 72% (n = 18) had CD and 60% (n = 15) were men. At baseline, 24 (96%) patients were in remission, 1 patient had mild disease, and none had moderate or severe disease.

After receiving a biosimilar for 6 months, 21 (84%) were still in remission, 3 (12%) had mild disease, 1 (4%) had moderate disease, and none had severe disease (baseline vs 6 months post-switch; P = .20).

Additionally, a statistically significant increase of patients requiring steroid therapy in addition to biologic therapy was observed for the ABP501 group (P = .01) but not the SB5 group (P = .50).

“This finding may imply a necessity of increased monitoring after switching therapy, in order to manage or prevent an exacerbation of the disease,” noted the investigators.

The need for optimization was not significant between baseline and 6 months post-switch in either group receiving a biosimilar.

Overall, 9 patients discontinued biosimilar therapy after 6 months, with 6 stopping therapy for ineffectiveness, 1 because they needed surgery, and 2 for adverse reactions. Except for 1 patient from the SB5 group who discontinued for adverse reactions, all the discontinuations were from the ABP501 group.

The investigators identified several limitations, including the modest sample size, the short follow-up period, the heterogeneous population at baseline, and the lack of immunogenicity values, such as antidrug antibodies.

Reference

Cingolani L, Barberio B, Zingone F, et al. Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator. Sci Rep. Published online May 14, 2021. Accessed May 20, 2021. doi: 10.1038/s41598-021-89790-4