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P344. Short and medium term efficacy of adalimumab in ulcerative colitis - a multicentre, prospective observational study

Z. Szepes1, A. Bálint1, M. Szücs2, F. Nagy1, K. Farkas1, R. Bor1, L. Lakner3, K. Palatka4, P. Miheller5, Á. Csontos5, G. Hegede6, G. Horváth7, I. Rácz8, Á. Vincze9, P.L. Lakatos10, P.A. Golovics10, Z. Gábor7, M. Juhász5, F. Zsigmond11, T. Wittmann1, T. Molnár1, 1University of Szeged, First Department of Medicine, Szeged, Hungary, 2University of Szeged, Department of Medical Physics and Informatics, Szeged, Hungary, 3Teaching Hospital Markusovszky, Department of Gastroenterology, Szombathely, Hungary, 4University of Debrecen, 2nd Department of Medicine, Debrecen, Hungary, 5Semmelweis University, 2nd Department of Medicine, Budapest, Hungary, 6Sándor Péterfy Hospital, First Department of Medicine, Budapest, Hungary, 7Semmelweis Health Center, Department of Gastroenterology, Miskolc, Hungary, 8Petz Aladár Hospital, First Department of Medicine, Györ, Hungary, 9University of Pécs, First Department of Medicine, Pécs, Hungary, 10Semmelweis University, First Department of Medicine, Budapest, Hungary, 11National Medical Center, Department of Internal Medicine, Budapest, Hungary

Background

Adalimumab is a relatively new therapeutic option in ulcerative colitis (UC). After the ULTRA trials only a few data have been published from the real clinical practice. The aim of this study was to prospectively follow the disease course in adalimumab-treated UC patients in Hungary. Primary endpoints were the remission and response rates at week 12 and 30; while secondary endpoints were the changes of C-reactive protein (CRP) levels and the clinical symptoms during the therapy.

Methods

56 patients who was treated with adalimumab at 10 tertiary Hungarian IBD centres were prospectively enrolled from May 2013 [male/female: 32/24; mean age: 41.9 years (in range: 21–68 years)]. 69.6% of the patients previously received infliximab therapy. Switch to adalimumab in these patients was due to loss of response or intolerance. Clinical data, partial Mayo (pMayo) score and CRP levels were collected at the beginning of adalimumab therapy, at week 12 and at week 30. Colonoscopy was performed before drug administration. Endoscopic Mayo subscore was used to assess the mucosal activity. Clinical remission was defined as less than or equal to 2 points in pMayo score; response to adalimumab was specified as decreasing 3 or more points.

Results

Adalimumab induction was administered at doses of 160 mg and 80 mg at week 0 and week 2. The mean value of Mayo score at the beginning of adalimumab therapy was 9.7 points. The mean values of pMayo subscores and CRP were 6.7 points, 14.2 mg/l at week 12, and 2.3 points, 7.2 mg/l at week 30, respectively. CRP levels and pMayo subscores decreased significantly at week 12 (p = 0.004, p < 0.001), while at week 30 only the decrease of pMayo subscore remained significant (p < 0.001). Remission, response and non-response rates were 23.2%, 75%, and 23.2% at week 12 and 54.5%, 81.8% and 18.2% at week 30. However, no significant difference was detected in the remission, response and non-response rates neither between week 12 and week 30 (p = 0.264) nor between patients previously treated with biologicals or naive to them. Adalimumab therapy needed to be discontinued in 6 subjects.

Conclusion

Our results suggest that adalimumab is an effective drug for the induction of remission and for the maintenance therapy of UC.