Treatment with upadacitinib induces clinical remission and endoscopic improvement in most patients with severe, refractory Crohn’s disease (CD) or ulcerative colitis (UC) with prior tofacitinib failure, regardless of previous response to tofacitinib, a study has shown.
Researchers performed a retrospective analysis of the safety and effectiveness of upadacitinib in 26 patients (16 CD and 10 UC; mean age 40.2 years; mean disease duration 14.4 years) with prior tofacitinib failure (median 5 advanced therapies). The median upadacitinib treatment duration was 13.9 months.
Among patients treated with upadacitinib, 10/12 (83.3 percent) achieved clinical response, 8/12 (66.7 percent) attained clinical remission, 10/14 (71.4 percent) showed endoscopic improvement, 8/14 (57.1 percent) exhibited endoscopic remission, and 5/14 (35.7 percent) had endoscopic healing.
Significant reductions were noted in the mean Simple Endoscopic Score in CD, from 14.3 to 8.6 (p=0.24), and in the mean Mayo Endoscopic Subscore, from 2.7 to 0.9 (p=0.006).
With regard to safety, most patients (73.1 percent) on upadacitinib experienced adverse events (AEs). The most common AEs were acne and minor infections. Serious AEs, major cardiovascular events, malignancies, or shingles did not occur.
“Further studies would define the long-term safety, efficacy, and predictors of response after previous JAK exposure,” the researchers said.
"Patients with severe, refractory CD or UC and inadequate response to medical therapy have a high risk of complications,” they said. “A better understanding of treatment response in the setting of prior failure may improve disease control in high-risk patients.”