Golimumab recently gained regulatory approval for the treatment of patients with moderate to severe ulcerative colitis (UC). Sandborn and his colleagues recently published data from a multicenter, phase III international trial (PURSUIT) demonstrating that golimumab, a fully humanized, subcutaneously injectable anti-TNF agent, results in significantly higher rates of clinical response, compared with placebo (at 6 weeks), in a cohort of individuals with moderate to severe UC. Golimumab maintained clinical response for a duration of 54 weeks in addition to achieving higher rates of clinical remission and mucosal healing, compared with placebo. Patients who achieved remission at week 6 were able to more effectively maintain remission up to week 52 when receiving the higher dose of golimumab every 4 weeks (100 mg vs. 50 mg). Based on these findings, golimumab became the third anti-TNF to market for patients with UC.
There are several interesting considerations when interpreting these results. Lower Mayo scores were associated with increased clinical remission rates, while lower serum markers of inflammation such as CRP and fecal lactoferrin were associated with greater initial response, likely representing decreasing disease severity. Several different induction regimens and modes of delivery (intravenous and subcutaneous) were used; however, the rates of response appeared comparable between groups. Lastly, there were more adverse events in the higher dosing arm (100 mg vs. 50 mg) of the study.
As with other anti-TNF agents, response rates increased with higher serum drug levels, further highlighting that we may not be reaching the full clinical potential of this class of medications until therapeutic monitoring becomes more accessible. In summary, this research adds another weapon to the current armamentarium in the management of patients with moderate to severe UC who are not yet considering definitive surgical therapy.
Dr. Frank I. Scott, MSCE, is an instructor of medicine, division of gastroenterology, and a faculty fellow, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia. Dr. Gary R. Lichtenstein is professor of medicine, University of Pennsylvania, and director, Center for Inflammatory Bowel Disease, department of medicine, division of gastroenterology. He is a consultant for Abbott/AbbVie, has received research funding from and consulted for Janssen Biotech and UCB.
