Sustained response to golimumab predicts good outcomes in ulcerative colitis

Last Updated: 2018-07-24

By Will Boggs MD

NEW YORK (Reuters Health) - Continuous clinical response (CCR) to golimumab treatment is associated with favorable outcomes in patients with moderate to severe ulcerative colitis (UC), according to a post hoc analysis of the PURSUIT-M trial.

"Most interesting to me is the fact that an approach of monitoring patient-reported outcomes in patients with UC appears efficient to treat towards the target of remission, including mucosal healing," Dr. Walter Reinisch from Medical University of Vienna told Reuters Health.

PURSUIT-M defined CCR as a clinical response that was maintained without treatment failure through 54 weeks.

In the current post hoc analysis, Dr. Reinisch and colleagues evaluated clinical, endoscopic, and quality-of-life benefits associated with CCR; the change in calprotectin level and need for colectomy in patients with and without CCR; and the effect of achieving CCR on the long-term disease course of moderate to severe UC.

Significantly more CCR patients than non-CCR patients achieved clinical remission, corticosteroid-free remission, endoscopic healing, endoscopic remission, and significant quality-of-life improvement, according to the July 6th Inflammatory Bowel Diseases online report.

During both induction and maintenance, median calprotectin levels were reduced in CCR patients but not in non-CCR patients.

Overall, 3.8% of patients needed colectomy. Most were done in patients who did not respond to induction, but none of the 13 patients who responded to induction and required colectomy had achieved CCR.

During the three-year long-term extension of PURSUIT-M, no or mild disease activity was sustained in 72% of CCR patients (versus 59% of non-CCR patients), and no disease activity was sustained in 58% of CCR patients (versus 42% of non-CCR patients).

"We should optimize treatment of patients early on if the (patient-reported outcomes) don't improve," Dr. Reinisch said. "If biomarkers are not available, monitor the symptoms of patients continuously and tightly, at least for the first six months. If . . . symptoms resolve, the likelihood of mucosal healing is very high."

"Ongoing research aims at translating the PURSUIT-M CCR tight control measure into a practical tight monitoring tool with use of remotely collected (patient-reported outcomes) and biomarkers aimed at avoiding clinic visits and endoscopy in UC patients," the researchers note.

Merck and Co., Inc. funded this study, and Janssen Research and Development sponsored PURSUIT-M. Seven of the 13 authors were employed by one of these companies, and five other authors had various relationships with one or both companies.

SOURCE: http://bit.ly/2Lmefj9

Inflamm Bowel Dis 2018.