The study aimed to verify the clinical results of the 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 have been extrapolated based on data from trials in patients with rheumatic diseases, suggesting that more concrete evidence is needed to confirm the effects in IBD in particular.
“Indeed, if we have considerably reduced the health costs associated with IBD treatments thanks to the adoption of these molecules, it is relevant to recognize that this was done without a coherent literature supporting their effectiveness and their safety in the field. gastroenterologic, ”the researchers wrote. .
IBD is an umbrella term for ulcerative colitis and Crohn’s disease (CD). IBD is often treated with anti-tumor necrosis factor alpha drugs, such as adalimumab, which can help patients control flare-ups, prevent complications, and slow disease progression.
The multicenter prospective cohort study recruited patients from the IBD unit of the University of Padua and 3 IBD centers in Santorso, Pisa and Genoa, Italy, and was conducted between October 2018 and July 2020.
Eighty IBD patients who initially received baseline adalimumab were included in the study and transferred to receive either ABP501 (n = 55) or SB5 (n = 25). The changed patients were age and sex matched with 38 patients, who acted as a control group and continued to receive baseline adalimumab for at least 2 years without switching to a biosimilar. Data was collected at baseline and 6 months after the change.
Of the patients who switched to ABP501, 45 (81.8%) had CD and 35 (63.6%) were males. At baseline, 47 (85.5%) patients were in remission, 5 (9.1%) had mild disease, 3 (5.4%) had 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%) moderate disease, and 1 (1.8%) severe disease ( at baseline vs. 6 months after the change); P = 0.09).
For the patients who 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 after the change); P = .20).
In addition, a statistically significant increase in the number of patients requiring corticosteroid therapy in addition to biological treatment was observed for the ABP501 group (P = .01) but not the SB5 group (P = 0.50).
“This finding may imply the need for increased surveillance after a change in treatment, in order to manage or prevent an exacerbation of the disease,” the investigators noted.
The need for optimization was not significant between baseline and 6 months after the change in either group receiving a biosimilar.
Overall, 9 patients discontinued biosimilar treatment after 6 months, 6 discontinued for ineffectiveness, 1 because they required surgery and 2 for adverse effects. With the exception of one patient in the SB5 group who discontinued for adverse effects, all of the discontinuations were from the ABP501 group.
The researchers 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 anti-drug antibodies.
Cingolani L, Barberio B, Zingone F et al. The adalimumab biosimilars, ABP501 and SB5, are just as effective and safe as the initiators of adalimumab. Sci representative. Published online May 14, 2021. Accessed May 20, 2021. doi: 10.1038 / s41598-021-89790-4