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Remicade, Entyvio ranked best first-line agents for moderate-to-severe UC
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Based on indirect comparisons, Remicade and Entyvio were the most effective first-line therapies for inducing remission and mucosal healing in moderate-to-severe ulcerative colitis, while Xeljanz was the best second-line therapy, according to new research published in Alimentary Pharmacology & Therapeutics.
However, investigators acknowledged that this evidence is limited, and that head-to-head trials are needed to better inform positioning of UC therapies in clinical practice.
“In this indirect comparison network meta-analysis, we analyzed first- and second-line therapies in patients with moderate-to-severe ulcerative colitis, and appraised the quality of evidence using the GRADE approach,” Siddharth Singh, MD, MS, of the division of gastroenterology at University of California, San Diego, told Healio Gastroenterology and Liver Disease. “We observed that infliximab and vedolizumab are probably the most efficacious medications for induction of remission and mucosal healing in biologic-naive patients with UC. In anti-TNF-exposed patients with UC, tofacitinib and vedolizumab are efficacious.”
To compare the safety and efficacy of pharmaceutical therapies for moderate-to-severe UC, Singh and colleagues reviewed studies published through May 2017 comparing anti-TNF agents, anti-integrin agents or Janus kinase (JAK) inhibitors to either placebo or another active agent. They included 12 randomized controlled trials of first-line agents in patients not previously treated with biologics (n = 2,720), including Remicade (infliximab, Janssen) Humira (adalimumab, AbbVie), Simponi (golimumab, Janssen), Entyvio (vedolizumab, Takeda) and Xeljanz (tofacitinib, Pfizer). They also included four randomized controlled trials of second-line agents (n = 967), none of which were head-to-head comparisons. They used surface under the cumulative ranking (SUCRA) probabilities to rank agents.
Based on moderate quality evidence, infliximab and vedolizumab were the most effective first-line agents for inducing clinical remission (OR = 4.22; SUCRA, 0.85 and OR = 4.26; SUCRA, 0.82, respectively) and mucosal healing (OR = 3.32; SUCRA, 0.91 and OR = 2.91; SUCRA, 0.81, respectively).
Also based on moderate quality evidence, tofacitinib was the most effective second-line agent among patients previously treated with an anti-TNF agent, again for inducing clinical remission (OR = 11.88; SUCRA, 0.96) and mucosal healing (OR = 4.71; SUCRA, 0.99).
“From a safety standpoint, vedolizumab appears safest in terms of serious adverse events,” Singh said.
While comparisons of efficacy for maintenance therapies were limited by variations in trial design, vedolizumab was ranked safest among maintenance therapies for both serious adverse events (SUCRA, 0.91), and infection (SUCRA, 0.75).
Aside from quality of evidence, Singh and colleagues noted that other factors should be considered in shared decision-making with patients and positioning of different therapies, “including a balance of risk-benefit profile, clinical judgement and experience of the treating physicians, values and preferences of patients as well as costs/resources available.” Considering the lack of comparative efficacy data, Singh and colleagues added that head-to-head trials are needed to inform practice, and noted that “ongoing trials comparing etrolizumab and vedolizumab to adalimumab as well as trials comparing standard vs. high-dose adalimumab would significantly enhance clinical practice.”
“While we await head-to-head trials and trials of high-dose adalimumab in UC, infliximab and vedolizumab may be considered as first-line therapies, whereas tofacitinib maybe reserved for second-line agent,” Singh said. – by Adam Leitenberger
Disclosures: Singh reports he has served as a consultant for AbbVie and has received research funding from the American College of Gastroenterology, the Crohn’s and Colitis Foundation, Pfizer and AbbVie. Please see the full study for a list of all other authors’ relevant financial disclosures.
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