Rinvoq 45 mg prompts ‘rapid resolution’ of Crohn’s disease symptoms as early as day 5
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Key takeaways:
- More patients treated with upadacitinib achieved remission in daily stool frequency and abdominal pain score vs. placebo.
- Clinical remission and response were higher with upadacitinib starting at week 2.
Once-daily Rinvoq 45 mg provided “rapid relief” of stool frequency and abdominal pain score within the first week of induction therapy in patients with moderately to severely active Crohn’s disease, according to a data analysis.
“In the U-EXCEL and U-EXCEED induction trials, upadacitinib 45 mg taken once daily demonstrated significantly greater efficacy vs. placebo for the co-primary endpoints of clinical remission and endoscopic response and most key secondary endpoints in moderately to severely active CD at week 12 and week 52, with a safety profile consistent with previous reports for upadacitinib,” Jean-Frédéric Colombel, MD, professor in the Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, and colleagues wrote in Clinical Gastroenterology and Hepatology.
To investigate the rapidity of symptomatic improvement with Rinvoq 45 mg (upadacitinib, AbbVie), researchers conducted a post-hoc analysis using pooled data from the U-EXCEL and U-EXCEED induction trials as well as the U-ENDURE maintenance trial. They included 1,021 patients with moderately to severely active CD, who received upadacitinib 45 mg (n = 674) or placebo (n = 347), and evaluated patient-reported diary data for the first 15 days to assess improvement in stool frequency (SF) and abdominal pain score (APS).
Researchers reported “similar” baseline values between treatment and placebo groups in SF (5.4 vs. 5.6, respectively) and APS (1.9 vs. 1.9). In addition, 72% and 71.5% of patients, respectively, had previous biologic failure.
According to study results, a higher proportion of patients treated with upadacitinib achieved daily SF remission beginning at day 5 vs. placebo (31.6% vs. 23.1%), as well as daily APS remission beginning at day 6 (49.1% vs. 39.3%), with differences in achievement continuing daily through day 15.
Further, greater mean changes in SF and APS were reported with upadacitinib beginning at week 2 (–2 vs. –1.1 and –0.52 vs. –0.33), which were maintained through week 12 (–3 vs. –1.8 and –1 vs. –0.55). Patients treated with upadacitinib also experienced earlier daily SF/APS clinical remission (median, 13 days vs. 32 days), as well as improved rates of SF/APS clinical remission (21.1% vs. 8.9%) and response (58.8% vs. 37.9%) starting at week 2.
“Patients with CD may benefit from a convenient therapy that provides quick improvement and early symptom resolution without the consequences of excessive or prolonged corticosteroid use,” Colombel and colleagues wrote. “Results from these analyses demonstrate that within 1 week of treatment, upadacitinib provides rapid resolution of CD symptoms for patients with moderate to severely active CD, irrespective of exposure to prior biological therapies.”
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