Infliximab Biosimilar Maintains Outcomes, Remission Status After Switch From Originator

Patients with inflammatory bowel disease (IBD) who had not been on biologics previously had positive responses and remission outcomes when started on infliximab-dyyb (Inflectra), an infliximab biosimilar, according to a study in Advances in Therapy. In addition, patients who switched from the originator product maintained clinical outcomes and remission status.

“Despite the clinical benefits of infliximab for IBD, cost remains a concern; therefore, biosimilars that are less expensive than reference product (RP) biologics but have similar effectiveness have been of high interest to payers and managed care organizations,” the authors wrote.

The ONWARD study enrolled patients from 24 sites across the United States and Canada who had Crohn disease (CD, n = 67) and ulcerative colitis (UC, n = 48). Among the total population, 39 were biologic-naïve, 57 had switched from RP infliximab (Remicade), and 19 had switched from other biologics.

All patients were followed for 12 months from baseline (the time of initiating infliximab-dyyb). Of the 115 total patients with IBD who initiated infliximab-dyyb from February 2018 to February 2020, 109 completed a 3-month visit, 99 completed a 6-month visit, and 84 complete the 12-month visit. More than half (n = 66; 57.3%) had received endoscopy at baseline and 37 patients had received endoscopy during the follow-up.

The most common reasons for to initiate infliximab-dyyb were:

• Related to reimbursement, insurance coverage, or out-of-pocket costs for patients switching from Remicade (80.4%)
• Targeted therapy (64.1%), improved efficacy (15.4%), and new drug availability (12.8%) for patients who were biologic-naïve

Only 6 adverse events caused patients to withdraw from the study: developing of antidrug antibodies, case of community-acquired pneumonia, hypersensitivity reaction, liver abscess, case of drug-induced lupus, and case of psoriasiform dermatitis and joint pain.

In patients with CD, the Harvey Bradshaw Index (HBI) score, which measures clinical outcomes, did not change significantly. The mean HBI scores were 3.45 at baseline, 3.11 at 3 months, and 2.98 at 12 months.

In patients with UC, the Partial Mayo score, which measures clinical outcomes, improved significantly from a mean of 3.85 at baseline to 1.44 at 3 months and 0.90 at 12 months. The improvement was more pronounced for biologic-naïve patients whose scores improved from a mean of 5.67 at baseline to 1.09 at 12 months. The mean score did not change significantly for patients switching from RP infliximab from baseline (1.38) to 12 months (0.85).

At baseline 34.5% of patients with UC and 72.7% of patients with CD were in remission. At 12 months, 87.1% of patients with UC and 77.1% of patients with CD were in remission.

The researchers measured patient-reported outcomes (PROs) with the Short Inflammatory Bowel Disease Questionnaire, the EuroQol Visual Analogue Scale, the Treatment Satisfaction Questionnaire for Medication, the Work Productivity and Activity Impairment questionnaire, the General Anxiety Disorder-7 questionnaire, and the Patient Health Questionnaire-8.

“PROs improved significantly from baseline to 12 months’ follow-up in nearly all questionnaires administered to participants,” the authors noted.

In addition to improve PROs, remission, and clinical outcomes, the authors found a decrease in health care resource utilization. At baseline, 9.6% of patients recorded an IBD-related hospitalization compared with 1.2% of patients during the 12-month follow-up period. Similarly, 10.4% of patients had an emergency department visit during the baseline period vs 3.6% during the 12-month follow-up period.

Among the limitations noted for the study was the small sample size. The authors noted that a lack of uptake of the infliximab biosimilar in the United States led to fewer study sites identifying and recruiting patients. “This was largely because infliximab-dyyb was not on their formulary or because patient insurance would not cover infliximab-dyyb,” they wrote.

Due to the small sample size, they note the findings on the subgroup of patients switching from other biologics should be “interpreted with caution” and additional larger studies need to confirm the findings.

Reference

Abraham B, Eksteen B, Nedd K, et al. Impact of infliximab-dyyb (infliximab biosimilar) on clinical and patient-reported outcomes: 1-year follow-up results from an observational real-world study among patients with inflammatory bowel disease in the US and Canada (the ONWARD Study). Adv Ther. Published online March 16, 2022. doi:10.1007/s12325-022-02104-6