First Brazilian Study of Adalimumab to Treat Ulcerative Colitis Demonstrates Efficacy and Safety

Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.

Katia Cristina Kampa, MD, and colleagues report that clinical remission was observed in approximately 40% of the patients at week 8 and at week 26, and in nearly a quarter of patients after 1 year of follow-up. Clinical response was observed in approximately 50% of the cases and a third of patients reached endoscopic remission. There were significant rates of secondary loss of response to adalimumab, however, followed by dose optimization or drug switching, the researchers report. The findings were published in the December 2017 issue of Arquivos de Gastroenterologia.

The longitudinal observational and retrospective study reports a case series of 36 patients with moderate to severe UC who were being treated with adalimumab in 7 Brazilian referral centers for inflammatory bowel disease (IBD). The data were analyzed from August 2014 to October 2016. The majority of patients had extensive colitis and long-term disease. Approximately a third had previously received infliximab therapy; 91.7% had used corticosteroids at the initiation of adalimumab, and two-thirds were using concomitant azathioprine during adalimumab treatment.

Clinical remission rates were 41.7% at week 8 (using Last Observation Carried Forward [LOCF] and Non-Responder Imputation [NRI] analysis methodology to account for patients who did not complete the full 52 weeks of the study) and 47.2% (LOCF) and 27.8% (NRI) at week 52. The study also reports a clinical response rate of 55.6% at week 8, similar to the pivotal ULTRA I and ULTRA II clinical trials; at week 52, clinical response was observed in 61.1% (LOCF) and 47.2% (NRI) of the cases.

Half of the patients lost clinical response during follow-up, with dose optimization to adalimumab weekly being required in 8 cases. A total of 16.6% of patients underwent colectomy during adalimumab treatment.

The overall rate of adverse events (AEs) was 67.9%, mainly due to infections. The researchers report a predominance of respiratory infections in this group of patients. Only 1 patient developed a non-melanoma skin cancer. None of the patients stopped treatment due to AEs.

The study was limited by having a small number of patients, and these patients had more severe and refractory disease. Many did not complete the 52-week period needed for full evaluation. The researchers were motivated to undertake the study because of the scarcity of real-world data on the use of adalimumab in UC reported in Brazil and Latin America.