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Thiopurines Offer no Clear Benefit Over Humira Monotherapy in Crohn’s Maintenance
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SAN DIEGO — Patients with Crohn’s disease who continued thiopurines in addition to scheduled Humira maintenance therapy experienced no clear benefit over those who received Humira alone, according to findings from the DIAMOND2 study presented at Digestive Disease Week.
“We aimed to study the influence of withdrawal of thiopurines in Crohn’s disease patients in corticosteroid-free remission with [Humira (adalimumab, AbbVie)] scheduled maintenance combined with thiopurines in an open-label, randomized, controlled trial,” Tadakazu Hisamatsu, of the third department of internal medicine at Kyorin University School of Medicine in Japan, said in his presentation.
In the study, researchers randomly assigned patients who were in corticosteroid-free remission for at least 6 months with adalimumab maintenance therapy with thiopurines to either continue (n = 22) or discontinue (n = 28) thiopurines. The primary endpoint was the proportion of patients who were in corticosteroid-free remission at week 52.
At baseline, both groups of patients had similar CD Activity Index Scores, Simple Endoscopic Score for CD, and serum C-reactive protein levels.
The proportion of patients who maintained corticosteroid-free remission at week 52 in the continue (95.5%) and discontinue (92.3%) groups was not significantly different. Patients in the continue and discontinue groups also achieved similar rates of endoscopic remission (30% vs. 32%), negative CRP (76.2% vs. 84.6%) and triple remission, a combination of steroid-free remission, endoscopic remission and negative CRP (22.7% vs. 28.6%).
Investigators did not observe any serious adverse events in either group.
“Continuation of thiopurines greater than six months offers no clear benefits over scheduled adalimumab monotherapy in patients who were in corticosteroid-free remission with concomitant use of thiopurines with scheduled maintenance of adalimumab for six months and more,” Hisamatsu said. – by Alex Young
Reference:
Hisamatsu T, et al. Abstract 834. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosures: Hisamatsu reports financial ties to AbbVie GK, Asahi Kasei Kuraray Medical, Astellas Pharma, Daiichi-Sankyo, EA Pharma, JIMRO, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda and Zeria Pharmaceutical. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.
Perspective
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Stephen B. Hanauer, MD
In the U.S. and Europe, the SONIC study compared Remicade (infliximab, Janssen) with azathioprine alone as well as the combination in patients with Crohn’s disease and the results demonstrated that the combination therapy was better.
The original DIAMOND study performed in Japan asked the same question but substituted Humira (adalimumab, AbbVie) for infliximab. In that initial DIAMOND study, the investigators did not see the same apparent benefits of combining adalimumab and azathioprine regarding clinical outcomes although endoscopic outcomes were better with combination therapy in the original DIAMOND study.
In the follow-up DIAMOND2 study, which is substantially underpowered, those who had received at least 6 months of combination therapy with adalimumab and a thiopurine were randomly assigned to either continue or discontinue the thiopurine. Patients were evaluated both clinically and endoscopically as well as with biomarkers such as C-reactive protein and the investigators did not demonstrate a difference in patients who continued vs. who discontinued the thiopurine with well over 90% of patients in both groups sustaining a steroid-free remission after 1 year.
The persistence of steroid-free remission of over 90% is substantially different, better than what we have seen in Western populations.
While it is an interesting study, I do not believe it is definitive; it is underpowered, and the results don’t really reflect a Western population.
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