Use of Infliximab or Adalimumab in Biologic-Naive Patients With Inflammatory Bowel Disease: Study of Patient Reported Outcomes in IBD Partners

BACKGROUND: We sought to compare Patient-Reported Outcomes Measurement Information System (PROMIS) measures and corticosteroid-free remission in biologic naive individuals with Crohn's disease (CD) or ulcerative colitis (UC) newly initiating therapy with adalimumab (ADA) or infliximab (IFX) in a large cohort of patients with inflammatory bowel disease (IBD).

METHODS: Using data from the IBD Partners cohort from April 2014 to July 2019, we performed longitudinal analyses comparing the effects of initiation of ADA or IFX therapy on PROMIS measures and corticosteroid-free remission. We included adult IBD patients who were naive to biologics and who started ADA or IFX within 90 days of their baseline visit. Patients were required to have at least one follow-up visit 91-365 days later. Patients were excluded if they had prior exposure to biologic therapy at baseline, history of ileoanal pouch or end ileostomy, or if they failed to include a start date for initiation of their biologic therapy. We performed bivariate analyses by IFX or ADA subgroup, followed by logistic regression models to investigate factors associated with steroid-free remission, stratified by CD or UC disease subtype.

RESULTS: A total of 256 biologic naive patients were included in our study. A total of 170 individuals started ADA (109 (64%) with CD and 61 (36%) with UC). Of the 86 patients initiating IFX, 51 (59%) had CD and 35 (41%) had UC. A majority of patients were female, Caucasian, and had similar mean age and disease duration at baseline. Overall, there were no significant differences at baseline of IBD-related hospitalization, prior IBD-related surgery, concurrent corticosteroid use, or immunomodulator (IMM) use between the ADA and IFX groups. No significant differences in anxiety, depression, fatigue, pain, sleep or social satisfaction were found at follow up between IFX and ADA groups overall, and for UC and CD subgroups. Reported rates of steroid-free remission at follow up were similar between biologic naive UC patients treated with ADA or IFX (37.1% vs 36.2%, P = 0.93). For UC, combination therapy with IFX and IMM had a higher rate of steroid-free remission as compared to IFX alone (53.8% vs 27.3%, P = 0.12), albeit not statistically significant. A similar trend was seen for ADA and IMM as compared to ADA alone (43.9% vs 35.3%, P = 0.20). Among biologic naive CD patients, rates of steroid-free remission at follow up were similar amongst groups (54.9% IFX vs 67.0% ADA, P = 0.14). Rates of steroid-free remission at follow up for combined therapy vs monotherapy were also similar for CD patients. In logistic regression models, only lack of steroid use at baseline was independently associated with steroid-free remission at follow up in CD patients (OR 0.37, 0.17-0.78).

CONCLUSION(S): Among this cohort of biologic naive IBD patients, therapy with ADA or IFX resulted in similar rates of corticosteroid-free remission. Other PROs including PROMIS measures of anxiety, depression, fatigue, pain, sleep, and social satisfaction were also similar in ADA vs IFX treated patients. These findings suggest the comparative effectiveness of ADA and IFX are similar.