Humira biosimilars Hyrimoz, Hulio show ‘positive clinical outcomes’ for patients with IBD
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Two adalimumab biosimilars, adalimumab-adaz and adalimumab-fkjp, demonstrated safety and effectiveness in patients with Crohn’s disease and ulcerative colitis, according to a study in PLOS One.
“The adalimumab biosimilars [Hulio (adalimumab-fkjp, Fujifilm Kyowa Kirin Biologics)] and [Hyrimoz (adalimumab-adaz, Sandoz)] are now available for clinical use in IBD in many countries all over the world,” Martin Wasserbauer, MD, of the department of internal medicine at Charles University and Motol University Hospital in Prague, and colleagues wrote. “Extensive laboratory non-clinical comparability exercises with [Hulio and Hyrimoz] were made which demonstrated high similarity with original adalimumab.”
The researchers added that, “subsequently, [biosimilar adalimumab] effectiveness and safety were proved in two large clinical studies and therapeutic indications were then extrapolated to all indications as with original adalimumab. [However,] to this date, there are relatively few published reports regarding clinical outcomes achieved with biosimilar adalimumab in patients with CD and/or UC.”
To assess the effectiveness and safety of biosimilar adalimumab compared with the original adalimumab (Humira, AbbVie), Wasserbauer and colleagues investigated the two biosimilars in a small patient cohort of biologic therapy-naive patients with either CD or UC.
Between June 2019 and August 2021, 50 patients (62% men, 68% CD, 32% UC) at seven gastroenterology departments in the Czech Republic received 160 mg of Hulio (n = 22) or Hyrimoz (n = 28) at week 0, 80 mg at week 2 and then 40 mg every 2 weeks, all given subcutaneously. Participants were monitored for 12 weeks.
Researchers assessed the biosimilars’ efficacy using the Crohn’s Disease Activity Index (CDAI) for CD and Mayo Scoring System (MSS) for UC. They defined remission as a CDAI score of less than 150 in patients with CD, and a total score on partial MSS index of less than or equal to 2 points for UC patients.
Among patients with CD, 73.5% achieved remission, 11.8% had a partial response (70-point decrease in CDAI score), 11.8% had no response and 2.9% discontinued therapy. Of those with UC, 18.8% achieved remission, 43.8% had a partial response ( 2-point decrease in partial MSS score), 25% had no response and 12.5% discontinued therapy.
Researchers further reported improvements in hemoglobin, fecal calprotectin, albumin and C-reactive protein serum levels after 12 weeks of biosimilar therapy.
In assessing the biosimilars’ safety, researchers noted the occurrence of seven adverse events, four of which were mild and included skin eczema and other infections.
“Limitations of this study are mainly a relatively small number of included patients, nonrandomized and nonblinded design of our study,” Wasserbauer and colleagues wrote. “However, despite these limitations, our results show positive clinical outcomes following administration of biosimilar adalimumab to IBD patients.”
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