| Contributors: |
Bossa, F.; Biscaglia, G; Valvano, Mr; Costantino, G; Lauria, A; Clemente, R; Ferracane, C; Shahini, E; Mendolaro, M; Grossi, L; Mazzuoli, S; Rispo, A; Pranzo, G; Sebkova, L; Tursi, A; Miranda, A; Patturelli, M; Spagnuolo, R; Ricciardelli, C; Sgarro, C; Paese, P; Inserra, G; Azzarone, A; Nardone, O; Fries, W; Buccianti, N; C Privitera, A; B Principi, M; Cappello, M; W Guglielmi, F; Romano, M; Riegler, G; Fanigliulo, L; Melina, R; Andriulli, A |
| Description: |
Background: Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis. Aims: To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response. Methods: Consecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system. Results: A total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p < 0.001). Multivariate analysis revealed that a higher total Mayo score (p < 0.001, OR 1.5, 95% CI 1.2-1.8) and naïve status to anti-TNF-alpha (p = 0.015, OR 3.0, 95% CI 1.2-7.5) were predictive of a favorable response. Seventy-seven (39.3%) of the 130 responders maintained a response at month 12 of therapy. There were 17 adverse events, 28 patients needed hospitalization, and 15 patients underwent surgery. Self-administration of the drug was appreciated by most patients. Conclusions: The efficacy and safety of golimumab in daily clinical practice were confirmed for the short- and long-term treatment of patients with active ulcerative colitis. Patients naïve to the anti-TNF-alpha monoclonal antibody and those with a higher total Mayo score were more likely to respond to golimumab. |