Early Monitoring of Response (MORE) to Golimumab Therapy: results of a multicenter, prospective observational trial

Background: The therapeutic goal of clinical remission in patients with moderate to severe ulcerative colitis (UC) is achieved after biological therapy only in 16% to 39%. Individualization of therapeutic intervention would benefit from prediction of early response. Study objective: The primary objective of our study was to assess golimumab (GLM) trough serum level of >= 2.5 mu g/mL in combination with a reduction of fecal calprotectin (FC) of >= 50% at week 6 compared to baseline to predict clinical response at week 26 after regular GLM intake. Methods: Patients with moderate to severe active UC and planed GLM treatment were recruited for a prospective, multicenter, observational study in Germany. Prediction of clinical response was assessed by FC and GLM trough level. Missing data was imputed as therapy failure according to the last observation carried forward (LOCF) method. Results: 59 patients have been enrolled. 54.2% of patients were anti-TNF naive. Clinical response at week 6 was a significant predictor for achieving clinical response at week 26 (odds ratio (OR) 10.97, CI 2.96-40.68; p<0.001). Moreover patients with a GLM trough level of >= 2.5 mu g/mL and a >= 50% reduction of FC at week 6 had an OR of 5.33 (95% CI 0.59 to 47.84) to achieve clinical response at week 26. Conclusion: Clinical response at week 6 is the best predictive marker for achieving clinical response at week 26. Consideration of significant reduction of FC and trough GLM serum levels could improve prediction of response.