Delayed Stelara response has similar prognosis to early response in UC, despite severity
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Key takeaways:
- Delayed ustekinumab responders had more severe endoscopic disease and abnormal C-reactive protein at baseline.
- There was no difference in clinical remission among early responders (41.1%) vs. delayed (34.8%) responders.
Among patients with ulcerative colitis, delayed Stelara responders had greater inflammatory burden at baseline compared with early responders, yet similar 1-year clinical remission outcomes, researchers reported.
“Many advanced therapies have come to market for treatment of inflammatory bowel disease in the past few years,” Neeraj Narula, MD, MPH, FRCPC, director of the IBD clinic at Hamilton Health Sciences and associate professor of medicine at McMaster University, told Healio. “Most of these have suggested that if patients do not respond to induction therapy, usually continuing therapy for another 2 to 3 months will lead to response in a portion of those initial non-responders.”
Narula continued: “However, it remained uncertain whether these ‘delayed responders’ do just as well as early responders to therapy.”
In a post-hoc analysis of patient-level data from the UNIFI study, Narula and colleagues evaluated 642 patients with UC treated with Stelara (ustekinumab, Janssen) to compare efficacy in patients with early or delayed response to treatment and identify factors that differentiate delayed responders from non-responders.
According to results, 50% of patients were early responders at week 8, 17.9% were delayed responders at week 16 and 32.1% were non-responders.
Compared with early responders, researchers noted delayed responders had more severe endoscopic disease at baseline as measured by Mayo endoscopic sub-score (76.5% vs. 64.2%), UC endoscopic index of severity (mean 4.8 vs. 4.4), abnormal baseline C-reactive protein greater than 3 mg/L (72.2% vs. 57%) and presence of bleeding (87% vs. 76.3%).
Researchers reported no other significant differences in baseline variables between early and delayed responders, highlighting similarity in prior biologic failure between groups (early, 44.2% vs. late, 41.7%).
Results also showed no differences in 1-year clinical remission among early responders vs. delayed responders (41.1% vs. 34.8%), respectively, or between groups for endoscopic improvement (47.4% vs. 40%), endoscopic remission (26.2% vs. 23.5%) or histo-endoscopic mucosal improvement (44.2% vs. 37.4%).
“In this analysis, we found that for UC patients treated with ustekinumab, delayed responders had similar prognosis to those who were early responders,” Narula told Healio. “Further, we found it was patients with heavier inflammatory burden who were more likely to need the additional weeks in order to obtain clinical response.
“In order to assist clinicians to differentiate which patient may be a delayed responder compared to a non-responder, we trended biomarkers during induction and early maintenance and found that certain biomarkers decline earlier in the patients who eventually turned out to be delayed responders.”
Specifically, compared with non-responders, delayed responders had a significant decline in CRP and fecal calprotectin, researchers reported.
“Clinicians can use biomarkers such as CRP to follow patients who start biologic therapy,” Narula said. “If a UC patient treated with ustekinumab has a decline in their CRP by week 8 but has yet to obtain clinical response, it may be worthwhile to continue with maintenance therapy as this patient has a higher probability to be a delayed responder.”
He continued: “It also helps set expectations appropriate in that when starting a patient with more severe UC on therapy, it may take longer for them to respond than someone with milder disease.”
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