Study Finds No Differences Between Adalimumab, Biosimilar for Inflammatory Bowel Disease

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There was no difference observed between adalimumab (Humira; AbbVie) and adalimumab-aacf (Idacio; Fresenius Kabi) for those who switched to the biosimilar.

In a study comparing adalimumab (Humira; AbbVie) and adalimumab-aacf (Idacio; Fresenius Kabi), a biosimilar of Humira, investigators found that there was no difference observed regardless of whether individuals started with the biosimilar or switched to the biosimilar for inflammatory bowel disease (IBD), according to results published in Farmacia Hospitalaria.

Medically accurate illustration of a womans large intestine | Image Credit: Sebastian Kaulitzki - stock.adobe.com

Image Credit: Sebastian Kaulitzki - stock.adobe.com

Several adalimumab biosimilars have been approved by the FDA. According to the study investigators, adalimumab-aacf was approved based on findings from a study that compared it to the reference product for moderate-to-severe chronic plaque-type psoriasis. The study authors said that few real-world analyses have been conducted to analyze the effects of individuals with IBD who switched from adalimumab to adalimumab-aacf.

Investigators aimed to analyze the effectiveness and safety of switching from adalimumab to adalimumab-aacf in patients with IBD, and the secondary aim was to analyze the outcomes of those who started on the biosimilar compared to those who started on the reference product. The study was retrospective and observational, including adults aged 18 years and older who were undergoing treatment with adalimumab and/or adalimumab-aacf for at least 3 months (in the non-switch cohort) or more than 6 months (for the switch cohort).

There were 44 individuals included with Crohn disease or ulcerative colitis who were treated with either adalimumab or the biosimilar between January 1, 2029, and February 28, 2022, at the study hospital. Thirty were in the reference product cohort, 5 were in the adalimumab-aacf start cohort, and 9 were in the switch cohort.

According to the study authors, the baseline and clinical characteristics were similar between the 2 groups, with the only difference being a longer duration of treatment for the reference product cohort compared to the adalimumab-aacf group. There were also no differences in the discontinuation rates. One individual in the reference product group required hospitalization, the study authors said.

In the adalimumab-aacf group, 3 of 5 of the individuals experienced adverse events (AEs), with 2 cases of musculoskeletal pain and 1 case of hair and skin rash, according to the results. The individuals who experienced the latter discontinued treatment.

Key Takeaways

  1. No significant differences were observed in effectiveness between patients who started with the biosimilar or switched from Humira to the biosimilar.
  2. Both medications had similar rates of adverse events, with no unexpected safety issues identified in the biosimilar group.
  3. The study also found a decrease in the use of corticosteroids after switching to the biosimilar.

In the adalimumab group, 8 of the 30 individuals experienced AEs, with 3 cases of hypertransaminasemia, and 1 case of periocular rash, 1 of bone fracture, 1 of musculoskeletal pain, 1 of herpes zoster, 1 of blurred vision, 1 of headache, and 1 of body tremors. There was also 1 case of cataract formation, and that patient discontinued treatment.

Investigators reported that there were no differences between the reference product group and the switch cohorts for age, gender, disease duration, disease behavior, tobacco smoking, and clinical findings. However, there were differences for thiopurines and treatment duration, according to the results.

For the differences pre- and post-switch, investigators noted that treatment duration was longer in the per-switch period and concomitant and sporadic use of corticosteroids and thiopurines decreased after the switch. Additionally, 2 of the 9 individuals experienced AEs following the switch, with 1 case of hypertransaminasemia and 1 for musculoskeletal pain. Neither individual discontinued treatment and no one in this group required hospitalization or surgery, according to the results. However, 1 individual discontinued adalimumab treatment due to loss of response after the switch.

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. 2024. doi:10.1016/j.farma.2024.01.002

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