The ONWARD study included patients who initiated therapy with the biosimilar, those who switched from the reference infliximab, or those who switched from a different biologic therapy.
Biosimilar infliximab, CT-P13, sold in the United States as Inflectra, has been the subject of increasing study in inflammatory bowel disease (IBD), with numerous studies reporting on its safety and efficacy in treating patients with Crohn disease (CD) or ulcerative colitis (UC).
The ONWARD study, a prospective, observational, multicenter study of patients whose are being treated for their IBD with the biosimilar, is adding to that body of evidence on improved patient-reported outcomes (PROs) with biosimilar infliximab, and researchers presented an interim analysis of data from ONWARD during the Academy of Managed Care Pharmacy Nexus 2019 meeting, held this week in National Harbor, Maryland.1
The study included patients who initiated therapy with the biosimilar (n = 41), those who switched from the reference infliximab (n = 51), or those who switched from a different biologic therapy (n = 14). Patients’ baseline characteristics were similar across the 3 groups. In total, 43 patients had UC and 63 had CD.
For patients who were new starts, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores and Visual Analog Scale (VAS) scores both improved by 8 points from baseline at 3 months (P <.001). Daily activity impairment scores improved by 19 points (P < 0.001), and overall work impairment score improved by 31 points (P = .188). The new start also had improved Personal Health Questionnaire-8 scores and Generalized Anxiety Disorder questionnaire scores.
Patients who switched from the reference infliximab, SIBDQ and VAS scores both improved by 3 points (P = .478, P = .757 respectively), and overall work impairment scores improved by 4 points (P = .221). For patients who switched from other therapies, statistically nonsignificant improvements were observed for all outcome measures.
These improvements in patient-reported outcomes associated with treatment with the biosimilar will be welcome news for patients with IBD, who face a high personal burden from poorly controlled disease. Two additional studies presented at the AMCP meeting focused on work productivity loss for patients with UC2 and CD3, and they cast into high relief the losses that patients face in terms of their productivity.
In both studies, the authors used data from the Adelphi Disease Specific Programme, which includes gastroenterologist-completed retrospective chart reviews and patient self-completed questionnaires for US patients for the years 2015 through 2017. The Work Productivity and Activity Impairment instrument was used to assess productivity loss.
Among patients with UC, overall mean work impairment for disease in remission was 7.5%, impairment for mild and moderate disease was 19.7%, and impairment for severe disease was 41.9% (P <.001). Mean annual indirect costs associated with impairment were $4432, $11,633 and $24,754 across the 3 disease severity groups.
Among patients with CD, overall mean work impairment for disease in remission was 12.4%, impairment for mild and moderate disease was 31.4%, and impairment for severe disease was 51.0% (P <.001). Mean annual indirect costs associated with impairment were $7308, $18,532, and $30,096 across the groups.
Both patients with UC and CD experienced increased absenteeism and increased presenteeism with worsening disease, and they experienced higher indirect economic losses, the researchers said.
1. Haider S, Kelton J, Shelbaya A, et al. Impact of infliximab-dyyb (infliximab biosimilar) on patient-reported outcomes: 3-month follow-up results from an observational real-world study among patients with inflammatory bowel disease in the US and Canada (the ONWARD study). Presented at: the Academy of Managed Care Pharmacy Nexus 2019; October 29 to November 1, 2019; National Harbor, Maryland. Abstract K1.
2. Ding Z, Obando C, Izanec J, et al. Work productivity loss and associated indirect costs by severity for patients with ulcerative colitis in the US. Presented at: the Academy of Managed Care Pharmacy Nexus 2019; October 29 to November 1, 2019; National Harbor, Maryland. Abstract K4.
3. Obando C, Ding Z, Izanec J, et al. Work productivity loss and associated indirect costs by severity for patients with Crohn’s disease in the US. Presented at: the Academy of Managed Care Pharmacy Nexus 2019; October 29 to November 1, 2019; National Harbor, Maryland. Abstract K5.