Switching from Humira to Biosimilar Did Not Affect Disease Control, Quality of Life in IBD

Findings of an Irish study published in the British Journal of Clinical Pharmacology demonstrate that switching from adalimumab (Humira; AbbVie) to a biosimilar, adalimumab-atto (Amjevita; Amgen), did not affect disease control or quality of life in patients with inflammatory bowel disease (IBD). Of note, the authors wrote that significant cost savings were achieved among patients following the switch to the biosimilar.¹

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Adalimumab is a monoclonal antibody designed to recognize and attach to tumor necrosis factor (TNF) in patients’ bodies. TNF is involved in causing inflammation and is found at high levels in those with diseases that Humira and Amjevita are indicated to treat, including IBD. When it attaches to TNF, adalimumab blocks its activity, therefore reducing inflammation and other symptoms of the diseases.²

Amjevita is a biosimilar to Humira. It acts on the immune system and is used in the treatment of inflammatory conditions including plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, IBD (Crohn disease and ulcerative colitis), polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis, axial spondylarthritis, hidradenitis suppurativa, and noninfectious uveitis. According to the European Medicines Agency, Amjevita is mostly used in adults when their conditions are severe, moderately severe, or getting worse, or when patients are unable to use alternative treatments.²

Amjevita has demonstrated high pharmacokinetic and clinical similarity to Humira. Because of the considerable cost savings possible when switching from a reference product to a biosimilar, the Irish National Medicines Management Programme recommends that patients switch from Humira to a biosimilar, such as Amjevita. However, the authors explained that switching to a lower-cost medicine may elicit a “nocebo effect,” in which the expectations of poorer efficacy impact patient outcomes despite pharmacological similarity.^1,3 For these reasons, the investigators conducted a prospective cohort study to examine clinical and economic outcomes as well as psychosocial variables in patients undergoing treatment for IBD who undergo a nonmedical switch from Humira to Amjevita.¹

In August 2020, all patients who were treated with Humira for IBD in one hospital were invited to switch to Amjevita. The primary end points were objective disease control, which was scored using objective disease scoring systems (Harvey-Bradshaw Index for Crohn disease or partial Mayo score for ulcerative colitis) administered 4 weeks prior to and following treatment switch, and incidence of the nocebo effect, which was defined as the worsening in subjective scores of IBD-related symptoms using the IBD Control Questionnaire (IBDQC) in the absence of objective evidence of an increase in disease activity measured using objective disease scoring systems and biochemical measures of inflammation or the emergence of new adverse events (AEs) related to the biosimilar. Additionally, fecal calprotectin and C-reactive protein were evaluated, and health anxiety was measured using the Health Anxiety Index (HAI).¹

In total, 64 patients aged 18 to 67 years with a diagnosis of IBD for about 12.38 years were enrolled. The investigators found that IBDCQ scores marginally improved following the switch to Amjevita (13.33 vs 12.49; P = .043). Of note, there were no significant changes in objective disease activity scores, fecal calprotectin, or C-reactive protein observed. Interestingly, there was also no significant difference in health-related quality of life as measured preswitch and postswitch. The mean EQ-5D-5L utility score was about 0.88 preswitch and 0.85 postswitch (t = −1.1306, df = 36, P = .27 [95% CI: −0.11, 0.03]), and the mean EQ-5D-5L visual analogue scale was 79.67 preswitch and 78.90 postswitch (t = 0.20463, df = 35, P = .84 [95% CI: −6.20, 7.58]).¹

A total of 16 patients reported 17 new AEs within 4 weeks. Logistic regressions revealed there was a significant relationship between HAI scores and AEs (P = .0079), with each unit increase in HAI score increasing the odds of reporting an AE by approximately 21%. Further, drug cost savings for the 64 patients over 8 weeks totaled €143,958.¹

“The relationship between health anxiety and the occurrence of AEs in this study may suggest that health anxiety could be an appropriate target for intervention to improve outcomes, or that prescribers should offer additional assistance to those with high levels of health anxiety at the time of biosimilar switching. Future longer-term studies are necessary to confirm safety, efficacy, and abeyance of AEs after switching,” wrote the study authors. “With biosimilar switching, prescribers may expect some patients to develop new AEs, particularly those with high levels of health anxiety.”¹

REFERENCES

1. Rabbitt L, Keogh Á, Duane L, et al. A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease. Br J Clin Pharmacol. 2025;91(9):2628-2635. doi:10.1002/bcp.70086

2. European Medicines Agency. Amgevita (adalimumab). Accessed September 11, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita

3. National Cancer Institute. Nocebo effect. Accessed September 11, 2025. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nocebo-effect