[Adalimumab as induction therapy for Crohn's disease - one center study]. / Adalimumab w indukcji remisji w chorobie Lesniowskiego- Crohna ­ studium jednoosrodkowe.

ABSTRACT

Adalimumab is a subcutaneously administered recombinant fully human monoclonal antibody targeting tumor necrosis factor alpha. It has been approved for use in Poland to treat patients with Crohn's disease under the program of Polish National Health Found since 2010. AIM: The aim of this study was to evaluate the efficacy of adalimumab monotherapy for inducing clinical remission in patients with active Crohn's disease . The primary outcome assessment was the reduction in score to 150 or below on the Crohn's Disease Activity Index (CDAI) at 12 weeks and the secondary one was the reduction in ΔCDAI of at least 100 points. MATERIALS AND METHODS: From January 2011 to December 2015 we treated 68 patients with active Crohn's disease (mean CDAI score 359). All the patients came from region of Silesia, an area with the same environment conditions. The patients were given adalimumab (Humira, AbbVie) subcutaneously at a dose of 160 mg at week 0, 80 mg at week 4 and 40 mg every two weeks thereafter. RESULTS: Twenty eight patients (41%) had a clinical remission at week 12 (CDAI ≤150) and 33 patients (49%) had a ΔCDAI response. During the 12-week of induction therapy infection with Clostridium difficile occurred in 4 patients and one patient died of a severe CMV infection. CONCLUSIONS: Adalimumab is effective as induction therapy for patients with moderate-to-severe Crohn's disease, however in individual cases serious infections including CMV infection can occur. A potential predictive factors for response can be female gender, non-smoking status and high CRP level at baseline.