Study Finds Infliximab Biosimilar Switch Is Safe, Effective for Patients with IBD

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For patients with inflammatory bowel disease (IBD), switching the infliximab biosimilars CT-P13 to SB2 is safe, does not affect treatment effectiveness or pharmacokinetics, and unassociated with negative major psychological side effects, according to a new study.¹

Although biosimilars are used to treat IBD, limited data exists on the effect of switching from 1 biosimilar to another. Yet, a study in 2022 observed the effects of switching biosimilars for patients with chronic inflammatory diseases and found that switching biosimilars, whether that be infliximab, adalimumab, or etanercept, is safe and effective. The investigators had examined disease activity, remission rate, loss of response, adverse events, and immunogenicity. ²

Similarly, the study, led by Giulia Privitera of University of Milan, sought to explore the effects of switching from 1 biosimilar to another in IBD patients—specifically the biosimilar CT-P13 to SB2. The investigators tested for effectiveness, safety, and psychological repercussions, as well as pharmacokinetic and inflammatory marker levels. ¹

Investigators included 119 patients in the study and followed this cohort for 12 months. They completed self-reported assessments, such as PRO2 for Crohn’s disease or ulcerative colitis, IBD-Disability Index, Functional Assessment of Chronic Illness Therapy Fatigue, and Short-IBD-Questionnaire. Patients also had the following psychometric tests: Hospital Anxiety and Depression Scale, Perceived Stress Scale, Perceived Stress Scale, and Believes About Medicine.

The investigators also recorded c-reactive protein levels, concomitant steroid use, and adverse events of interest. Serum samples were also collected before and after the biosimilar switch to measure infliximab and anti-INX trough levels, as well as cytokine concentrations.

More than half of the patients had Crohn’s disease (n = 73) and 46 had ulcerative colitis. The mean age was 40 years, and the average disease duration was 9 years. On average, patients took the pre-switch infliximab for 3 years (45 months). Less than half (42%) of the patients previously received infliximab originator-to-CT-P13 switch.

The investigators collected mean stool frequency scores. For patients with ulcerative colitis, mean stool frequency scores were 0.2±0.5 at baseline, 0.4±0.8 at 2 months, 0.7±1.5 at 6 months, and 0.2±0.5 for 12 months. Then, for mean rectal bleeding, the scores were 0.1±0.4 at baseline,0.1±0.4 at 2 months, 0.4±0.8 at 6 months and 0.0±0.0 at 12 months.

Meanwhile, for patients with Crohn’s disease, mean stool frequency scores were 1.9±2.0 at baseline, 2.1±2.2 at 2 months, 1.8±1.9 at 6 months, and 1.5±1.8 for 12 months.The mean abdominal pain scores were 0.5±0.7 (baseline), 0.4±0.6 (2 months), 0.3±0.6 (6 months), 0.2±0.5 (12 months). The results, from baseline to 12 months, were statistically significant (P = .01.). Therefore, patients had lower mean stool frequency scores and abdominal pain scores after switching biosimilars.

C-reactive protein levels were consistently <5mg/L. The results were as followed: 3.4±8.0 (baseline), 3.2±5.8 (2 months), 2.4±4.0 (6 months), 2.2±5.7 (12 months).

The investigators found no significant changes in psychometric assessments during the follow-up. The results were as followed:

• Hospital Anxiety and Depression Scale: 10.3±6.8 (baseline), 10.6±8.1 (2 months,), 11.3±8.1 (6 months)
• Perceived Stress Scale: 14.3±7.8 (baseline), 15.7±8.8 (2 months), 14.9±8.1 (6 months)
• IBD-Disability Index: -0.7±4.6 (baseline), -1.3±5.9 (2 months), 9.0±4.7 (6 months)
• Functional Assessment of Chronic Illness Therapy Fatigue: 42.2±8.9 (baseline), 40.6±10.8 (2 months), 41.8±8.6 (6 months)
• Short-IBD-Questionnaire: 55.2±11.4 (baseline), 54.1±11.8 (2 months), 56.7±10.7 (6 months)
• Believes About Medicine-S1-SS1: 18.0±3.4 (baseline) 18.0±2.3 (2 months), 17.5±2.9 (6 months)
• Believes About Medicine-S1-SS2: 8.7±2.9, (baseline) 8.6±3.0 (2 months), 9.0±2.7 (6 months)
• Believes About Medicine- S2-SS2 (8.7±2.9 (baseline), 8.6±3.0 (2 months), 9.0±2.7 (6 months).

Infliximab anti-IFX trough levels were stable before and after the biosimilar switch (4.07 vs 4.86 μg/mL). Some patients developed anti-IFX antibodies; such antibodies were detected in 5.1% before the switch and 2.5% after the switch. Adverse events occurred in 36.1% of patients (n = 43), and such conditions were infections (n = 17) and arthralgias (n = 15). Cancer was detected in 3 patients.

“Switching from CT-P13 to SB2 can be considered safe, does not significantly affect treatment effectiveness nor drug pharmacokinetic, and is seemingly not associated with major negative psychological implications,” the investigators wrote.

References

1. Privitera, G, Melita, E, Monastero, L, et al. Infliximab Biosimilar Switch Is Safe and Effective, It Does Not Have Major Psychological Implications And Does Not Affect Pharmacokinetics In A Large Cohort Of Patients With IBD. United European Gastroenterology Journal. 2023;Vol 11: 1029. DOI: 10.1002/ueg2.12461
2. Allocati E, Godman B, Gobbi M, Garattini S, Banzi R. Switching Among Biosimilars: A Review of Clinical Evidence. Front Pharmacol. 2022;13:917814. Published 2022 Aug 24. doi:10.3389/fphar.2022.917814