February 20, 2019
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Optimized Remicade monotherapy effective for IBD induction

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Remicade monotherapy with optimized dosing was an effective treatment for patients with inflammatory bowel disease beginning induction therapy, according to data published in Alimentary Pharmacology & Therapeutics.

David Drobne, MD, PhD, of the department of gastroenterology at University Medical Centre Ljubljana in Slovenia, and colleagues wrote that combination therapy with azathioprine has been the preferred method of Remicade (infliximab, Janssen) induction because of improved pharmacokinetics and lower drug consumption. However, monotherapy has become increasingly common as the addition of infliximab biosimilars has lowered treatment costs.

“It is unclear whether substituting the 612 months of combination treatment with optimized infliximab monotherapy results in equal short and longterm clinical effectiveness,” they wrote. “It is also unknown to what extent the optimized infliximab monotherapy increases the consumption of costly infliximab in comparison to combination treatment, which is currently the preferred strategy in most IBD centers.”

Researchers studied the clinical success and infliximab consumption of both strategies in 149 patients with IBD starting induction and undergoing intensive drug monitoring assisted treatment optimization.

They found that patients in the mono and combination therapy groups had similar drug retention rates after induction (96% vs. 97%), after the first year (90% vs. 83%) and at the end of follow-up (74% vs. 75%). Both groups also had similar rates of steroid use at one year (5% vs. 14%; P = .08) and mucosal healing at the end of follow-up (64% vs. 67%)

Investigators found that the monotherapy group had higher infliximab consumption (7.6 mg/kg every 8 weeks; interquartile range [IQR], 5.9-10.3 vs. 6.4 mg/kg every 8 weeks; IQR, 5.28; P = .019) and lower trough levels (1.7 µg/mL; IQR, 0.36.6 vs. 5 µg/mL; IQR, 2.58.7; P = .012) compared with the combination therapy at year one. However, once patients in the combination group discontinued azathioprine for a median of 14 months, the differences disappeared.

Drobne and colleagues wrote that patients receiving optimized infliximab monotherapy can achieve similar outcomes as patients who also receive azathioprine as long as they receive higher doses of drug during the first year of treatment.

“Azathioprine cotreatment had no impact on the longterm clinical outcome of patients and only a transient infliximabsparing effect for the duration of azathioprine cotreatment,” they wrote. “Our results, together with the findings of others, indicate that routine use of azathioprine cotreatment during introduction of infliximab in patients who previously failed azathioprine is questionable. The efficacy, safety and costeffectiveness of optimized infliximab monotherapy should be evaluated in a prospective study.” – by Alex Young

Disclosures: Drobne reports serving as a speaker, consultant and advisory board member for AbbVie, Janssen, Krka, MSD, Pfizer and Takeda. Please see the full study for all other authors’ relevant financial disclosures.