Patients with Crohn’s achieve tight disease control with long-term Rinvoq treatment
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Patients with Crohn’s disease in their second year of treatment with Rinvoq showed sustained improvements in disease control, deep remission and quality of life, according to research presented at the American College of Gastroenterology Annual Scientific Meeting.
Geert D’Haens, MD, PhD, from Amsterdam University Medical Centers in the Netherlands, said the CELEST phase 2 study showed that more patients with CD achieved endoscopic and clinical remission with Rinvoq (upadacitinib, AbbVie) compared with placebo after 16 weeks of treatment. Researchers also observed improved outcomes through a 26-week maintenance treatment.
“The ongoing CELEST Open Label Extension study was set up to evaluate long-term efficacy, safety and tolerability of upadacitinib in CELEST study completers for up to 8 years,” he said. “We wanted to validate the efficacy of upadacitinib after 2 years of exposure via stringent composite endpoints, as well as separate indices related to disease activity and quality of life.”
Researchers enrolled patients who completed the 52-week CELEST study in an open-label extension in which they received upadacitinib once daily for up to 8 years. Patients on double-blind therapy in the CELEST study received 15 mg daily in the OLE study (n = 76), while patients on open-label rescue therapy received 30 mg daily (n = 31).
Investigators examined the changes in the proportion of patients in clinical and endoscopic remission or response, steroid-free remission and CD Activity Index remission at week zero and 12 months. They also assessed stool frequency, abdominal pain, endoscopic score and IBD questionnaire.
At baseline of the OLE study, researchers observed that 14% of patients in both dosing groups were in clinical and endoscopic remission. At 12 months, 36.6% of patients in the 15 mg group and 31.6% in the 30 mg group were in clinical and endoscopic remission. Steroid-free CDAI remission was similar at 12 months and baseline in the 15 mg group (85.7% vs. 70.4%), but they were higher in the 30 mg group (72.7% vs. 56.2%).
Patients maintained stool frequency and abdominal pain between week zero and 12 months and saw improvements to both endoscopic score and extraintestinal manifestations.
“The second year of upadacitinib treatment showed sustained improvements in stringent, composite measures of CD severity, and there were no new safety risks observed, consistent with double-blind CELEST results,” D’Haens said. “Patients with moderate-to-severe Crohn’s disease requiring long-term therapy with upadacitinib achieve tight disease control, deep remission and improved quality of life.”
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