Patients, especially those with chronic diseases, often are nervous about switching from a brand-name drug to a biosimilar.
That’s one of the reasons a new study published in the Journal of Crohn’s and Colitis looked at biosimilar substitution in nearly 500 inflammatory bowel disease (IBD) patients.
International authors from Western General Hospital in Edinburgh, Scotland, and Radboud University Medical Center in Nijmegen, the Netherlands, point out that multiple adalimumab (ADA) biosimilars are now approved for use in IBD but that information on their effectiveness and safety data remain limited.
The FDA has given the okay to six biosimilar products for adalimumab, marketed as Humira, with many more in the pipeline. Researchers sought to assess long-term outcomes of the adalimumab (ADA) biosimilar SB5 in IBD patients following a switch from the ADA originator (SB5-switch cohort) or after start of SB5 (SB5-start cohort).
Their observational cohort study was performed in a tertiary IBD referral center, with all IBD patients treated with Humira undergoing an elective switch to SB5. Those patients were identified in a biologic prescription database that prospectively registered all ADA start and stop dates including brand names. Researchers compiled data on IBD phenotype, CRP, drug persistence, ADA drug, and antibody levels.
Ultimately, 481 patients were treated with SB5, including 256 in the SB5-switch cohort with median follow-up of 13.7 months and 225 in the SB5-start cohort with a median follow-up of 8.3 months [4.2-12.8]).
In terms of adherence, researchers report that 70.8% of the SB5-switch cohort remained on SB5 beyond a year, while 90/256 discontinued SB5, mostly due to adverse events (46/90) or secondary loss of response (37/90).
In the SB5-start cohort, 81 patients discontinued, resulting in SB5-drug persistence of 60.3% beyond 1 year.
The authors point out that no differences in clinical remission (P = .53), CRP (P = .80), fecal calprotectin (P = .40) and ADA trough levels (P = .55) were found between baseline, week 26, and week 52 following therapy switch. The most frequently reported adverse event was injection-site pain.
“Switching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up,” the researchers conclude.
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