Colectomies ‘infrequent’ in patients with moderate to severe UC receiving tofacitinib
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Key takeaways:
- Over a maximum of nearly eight years of tofacitinib exposure, 14 patients underwent colectomy.
- All patients had tumor necrosis factor inhibitor failure and most had at least three risk factors for colectomy.
All patients with moderate to severe ulcerative colitis in the tofacitinib OCTAVE UC clinical program who underwent colectomy had prior tumor necrosis factor inhibitor failure and most had additional risk factors, according to analysis.
“Real-world studies have demonstrated that colectomy rates among patients with UC have varied over time and by geographic location,” David T. Rubin, MD, Joseph B Kirsner Professor In Medicine and chief of the section of gastroenterology, hepatology and nutrition at University of Chicago Medicine, and colleagues wrote in Therapeutic Advances in Gastroenterology. “Overall, up to one in five patients with UC will require surgery within 10 years of diagnosis.”
They continued: “Colectomy data from the global tofacitinib OCTAVE UC clinical program have not been reported previously.”
In a post hoc analysis, Rubin and colleagues evaluated data from participants in the phase 3 induction studies (OCTAVE induction 1 and 2; n = 1,139), the 52-week maintenance study (OCTAVE sustain; n = 593) and the open-label extension study (n = 944) to determine risk factors and incidence rates of colectomy.
At baseline, researchers evaluated risk factors based on ACG guidelines, which included aged younger than 40 years at diagnosis, extensive colitis, severe endoscopic disease (Mayo endoscopic subscore [MES] = 3), hospitalization for UC within 12 months before induction, C-reactive protein greater than 3 mg/L and serum albumin less than 3.5 g/dL.
Over a maximum of 7.8 years of tofacitinib exposure, 14 patients underwent colectomy. Of those, three occurred during induction (tofacitinib 10 mg twice daily, n = 2; placebo, n = 1), three during maintenance (placebo, n = 3) and eight during the open-label extension period (tofacitinib 10 mg twice daily, n = 8).
The overall incidence rate of colectomy for all patients who received at least one dose of tofacitinib was 0.34 (95% CI, 0.16-0.63) per 100 patient-years.
Further, patients who underwent colectomy had at least one risk factor for colectomy and most (n = 11) had at least three risk factors, the most common of which were an MES of 3 (n = 13), CRP greater than 3 mg/L (n = 11) and aged younger than 40 years at diagnosis (n = 9). These patients also had previous tumor necrosis factor inhibitor failure.
“In this analysis of patients with moderate to severe UC in the tofacitinib OCTAVE UC clinical program, colectomies were infrequent; as expected, all events occurred in patients with prior TNFi failure and most patients had multiple additional risk factors that were previously identified in clinical guidelines,” Rubin and colleagues concluded.
“Recognition of factors associated with risk of poor prognosis or colectomy is significant when evaluating the risk and benefits of different surgery or treatment options and identifying the appropriate, individualized treatment options for a UC patient.”
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