Treatment-Naïve Crohn's Disease Patients Have Similar Remission Rates Despite Difference in Therapy

Patients with Crohn’s Disease receiving infliximab or adalimumab had similar remission rates and few side effects, the results of an Italian study suggest.

Infliximab and adalimumab therapy had comparable results in treatment-naïve Crohn’s disease patients, with few serious side effects, suggests a study published online on March 13, 2014, in the European Journal of Internal Medicine.

“We found that both [infliximab] and [adalimumab] are effective in obtaining and maintaining remission,” the authors wrote. “In particular, both drugs obtained a significant remission rate during follow-up, with no statistically significant difference. The condition of [Crohn’s disease] naïve to anti—[tumor necrosis factor]α therapy may be one of the factors that partially explain the high percent of remission in our population. . . At the same time, our results seem to be particularly interesting, because the populations involved in our study were similar, and affecting factors that may influence the response to therapy, including longer disease duration or steroid-refractoriness, were complicated.”

Researchers assessed 126 treatment-naïve participants with Crohn’s disease receiving infliximab or adalimumab. Fifty-nine participants received infliximab during the study, and 66 participants received adalimumab. Researchers gauged clinical efficacy, mucosal healing, histologic healing, and safety for each therapy.

All participants attained clinical remission or response, researchers determined. Participants continued to undergo scheduled treatments, and remission persistence at the 36-month follow-up was comparable between the 2 treatment groups.

In addition, only 3 participants required dosing or interval adjustments to maintain remission, the authors noted.

Ten participants reported side effects, including infusion injection reactions and cutaneous and musculoskeletal complications. Infusion injection reactions, including itching, shortness of breath, hives, headache, and other skin reactions, were observed in 8 participants receiving infliximab and 5 participants receiving adalimumab. Researchers observed single cases of joint complaints and headache: 1 in the infliximab cohort, and 1 in the adalimumab cohort.

Cutaneous complications were observed in 9 participants overall: 5 participants in the infliximab group, and 4 in the adalimumab group. The authors noted that cutaneous reactions in 2 participants in the infliximab group were severe enough to warrant treatment cessation.

In addition, researchers reported that 1 participant in the adalimumab group developed mastitis that required suspension of treatment.

Participants received ileo-colonoscopies at the start of the study, as well as at the 6-month and 12-month marks, and then every 12 months after the first year of therapy to assess endoscopic severity. Mucosal healing was observed in similar percentages in each therapy group, although it varied depending on disease location. In general, healing was observed more frequently in upper gastrointestinal and ileal locations than in ileo-colonic, colonic, and perianal locations.

Complicated mucosal healing, defined as ulcer healing with either bowel deformation and/or the inability to complete colonoscopy due to scars, occurred in 28.8% of participants receiving infliximab and 10.6% of participants receiving adalimumab.

“Increasing evidences support the importance of assessment of [mucosal healing] in inflammatory bowel disease, in particular in ulcerative colitis,” the authors noted. “Its use is also assuming an increasingly important role in the follow-up of individual [Crohn’s disease] patients in clinical practice, even if a validated definition of mucosal healing in Crohn’s disease does not exist yet.

“ . . . We found that [mucosal healing] persists in a high percentage of both [infliximab] and [adalimumab] patients at the end of follow-up without any significant difference. It is likely that the relevant percentage of patients with less severe [Crohn’s disease] may explain our results.”