The following article is a part of conference coverage from the Digestive Disease Week 2021 Annual Meeting , held virtually from May 21 to 23, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from DDW 2021.
The majority of patients who achieved remission from ulcerative colitis (UC) with tofacitinib were able to maintain remission over long-term follow-up, according to study data presented at Digestive Disease Week 2021.
The OCTAVE Open trial was an open-label, long-term extension study of twice daily (BID) tofacitinib for the maintenance of remission in severe UC. OCTAVE Open enrolled patients who completed the 52-week follow-up period of OCTAVE Sustain, a randomized, placebo-controlled trial of tofacitinib efficacy. Remission was defined by a total Mayo Endoscopic Score of ≤2 with no individual subscores >1 and a rectal bleeding subscore of 0. Patients were followed for up to 36 months during the open-label extension (OLE) period. Safety and efficacy data were collected throughout follow-up.
Of 944 patients who entered the open-label extension study, 163 were in remission by week 52 of the preceding trial (OCTAVE Sustain). Among remitters, 66 (40.5%) had received tofacitinib 5 mg BID, 76 (46.6%) had received tofacitinib 10 mg BID, and 21 (12.9%) had received placebo. All patients in remission at the start of the OLE study were switched to tofacitinib 5 mg per protocol.
A total of 79 (48.5%) patients in remission discontinued the OLE study during follow-up: 20 (12.3%) due to adverse events and 19 (11.7%) due to insufficient clinical response. Among patients who continued the OLE study, efficacy was largely maintained over 36 months. Rates of remission maintenance, endoscopic improvement, and clinical response were similar across baseline tofacitinib dose groups.
Of the 175 patients who received tofacitinib 5 mg BID during the OLE study, 154 (88.0%), 39 (22.3%), and 25 (14.3%) experienced adverse events, serious adverse events, and severe adverse events, respectively. The most common treatment-emergent adverse events were worsening UC (n=47; 26.9%) and nasopharyngitis (n=41; 23.4%).
Other adverse events in this dose group included serious infections (incidence rate 1.25 per 100 person-years [PY]), herpes zoster (2.08 per 100 PY), opportunistic infections (0.63 per 100 PY), major adverse cardiovascular events (0.31 per 100 PY), malignancies excluding non-melanoma skin cancer (1.09 per 100 PY), and non-melanoma skin cancer (0.96 per 100 PY). No cases of deep vein thrombosis, pulmonary embolism, or death were reported in the 5 mg group.
Per these data, tofacitinib 5mg BID is sufficient to maintain remission from UC in patients who achieved remission with either 5 mg or 10 mg. Remission rates were comparable between patients whose dosage was reduced from 10 mg to 5 mg and patients who received 5 mg throughout the prior trial and the OLE period. No new safety signals were observed.
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Colombel JF, Osterman MT, Ibanez P, et al. Maintenance of remission with tofacitinib in patients with ulcerative colitis: final results of a subpopulation analysis from an open-label, long-term extension study, octave open. Presented at: Digestive Disease Week Annual Meeting; May 21-23, 2021. Abstract 649.