Golimumab for Ulcerative Colitis: One More Option to SAVE the Colon

Ulcerative colitis (UC) is one of the subtypes of inflammatory bowel disease (IBD) which shows relapsing and remitting disease course without cure.¹ Because the incidence and prevalence of IBD are continuously increasing in both developed and newly industrialized countries, IBD has become a global disease.² After introducing antitumor necrosis factor agents for treating IBD during the past decades, the therapeutic armamentarium was widely expanded to manage moderate-to-severe UC.¹ However, there has been sparse evidence on the long-term (more than 2–3 years) efficacy and safety of these medications for UC. Although colectomy with a pouch formation would be a reasonable option for medically refractory UC, patients with UC who underwent pouch surgery sometimes suffer from the problems of pouch such as chronic pouchitis along with poor quality of life.³ For these reasons, medications with long-term efficacy, safety, and durability for UC are inevitable for the management of chronic, noncurable disorders.

In this issue of Crohn’s & Colitis 360, Weinstein et al. analyzed the incidence of all-cause colectomies in patients with moderate-to-severe UC using the data from the PURSUIT-Maintenance Extension study.⁴ During the 4 years of study periods, 4.9% of patients with UC receiving golimumab underwent colectomies and the colectomy rate during the 3-year extension period was lower than that of first year maintenance period (1.4% vs 4.2%). The majority of colectomies were reported in golimumab-induction nonresponders and patients with more severe disease at baseline. Before the ­present study, we already had evidence of long-term (4 years) efficacy and safety of subcutaneous golimumab for moderate-to-severe UC from the PURSUIT-Maintenance Extension study, in which golimumab showed no new safety signals along with an excellent efficacy profile including quiescent disease activity, corticosteroid-free, and good quality of life among the golimumab-induction responders.⁵ Also, golimumab showed very stable pharmacokinetic status with a low rate of developing antidrug antibodies (less than 5%) through 4 years.⁵ The favorable efficacy and safety of golimumab for UC were replicated in the Japanese study and a real-world experience from Spain.^6,7

In the present study, Weinstein et al. filled the knowledge gap on the risk of colectomies in golimumab-treated patients with UC in the long term.⁴ The colectomy rate during the study periods seems comparable to the previous real-world data.⁷ However, the rate of colectomy in the present study seems lower than previously reported population-based studies (7%–9% at 5 years after diagnosis of UC) or other studies of anti-TNF agents for UC (10% for infliximab through 54 weeks and 11.5% for adalimumab with a median 12.1 months of observation).^8–10 This difference might be from the selection bias and the study heterogeneity. However, the results of the present study reassured us in regard to the good safety profile and colectomy-free survival of golimumab for UC. In addition, golimumab has the advantage of subcutaneous injection with time-saving, the ability to have treatment at home, and no risk of infusion reactions.

In the future, we should have evidence of the longer-term (more than 5 years) efficacy and safety data of golimumab therapy for moderate-to-severe UC in terms of mucosal healing, histologic healing, and the rationale for combination therapy with immunomodulators for the prevention of developing antidrug antibodies. Also, golimumab may have a role as a combination of biologics, which is suggested by the proof-of-concept study of guselkumab plus golimumab combination therapy in UC.¹¹ Moreover, the role of golimumab for the disease modification of UC in the long term should be evaluated because current evidence has not confirmed the progressive nature of UC like Crohn’s disease.¹² Although we have a lot of questions to be answered to improve the long-term outcomes of UC, especially moderate-to-severe disease activities, we have one more option, golimumab, to save the colon of UC patients.

Funding

None declared.

Conflicts of Interest

S.H.P. holds the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript.