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March 09, 2022
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Research reveals high levels of long-term tofacitinib treatment persistence in UC

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Researchers observed high levels of tofacitinib persistence for the long-term treatment of patients with ulcerative colitis, according to a study published in Alimentary Pharmacology & Therapeutics.

The efficacy and safety of tofacitinib have been widely demonstrated in phase 2 and 3 induction and maintenance studies, as well as a long-term, phase 3 extension study known as OCTAVE Open. To further examine tofacitinib survival and persistence in patients with UC, Remo Panaccione, MD, of the University of Calgary, and colleagues conducted a post-hoc analysis of the OCTAVE Open, studying patients dosed with 5 mg or 10 mg twice daily up to 7 years.

According to results of the OCTAVE Open study, the median tofacitinib persistence among all responders with ulcerative colitis was 5.6 years.

Of 603 patients, 280 entered the study with a clinical response (164 in remission), 220 entered as delayed responders, 75 as retreatment responders and 35 as dose-escalation responders.

According to results, the median tofacitinib persistence among all responders was 5.6 years with estimated 2-year and 5-year drug survival rates higher among responders in remission (76.8% and 56.9%) compared with responders not in remission (69.8% and 50%). Researchers noted comparable median persistence among patients who were delayed responders (4.5 years), retreatment responders (4 years) and dose-escalation responders (4.4 years). Two-year and 5-year drug persistence rates were 69.5% and 45.2% among patients with a delayed response, 70.7% and 40% among patients with a retreatment response and 74.3% and 32.8% among patients with a dose-escalation response.

Further analysis revealed that participants younger than 40 years, those dosed with tofacitinib 10 mg at baseline and those with prior tumor necrosis factor inhibitor failure were at greater risk for discontinuation from treatment in OCTAVE Open.

“High levels of tofacitinib treatment persistence were observed across the selected subpopulations of patients analyzed in the OCTAVE Open open-label, long-term extension study that followed patients for up to 7 years, with median time to discontinuation ranging from 4 to 5.6 years,” Panaccione and colleagues concluded. “These data further support the use of tofacitinib in the long-term management of UC. Further research should focus on factors to enhance persistence with tofacitinib treatment in patients with UC.”