Gastro hep advances · 2026
Efficacy of Upadacitinib Retreatment or Dose Escalation After Loss of Response in Ulcerative Colitis: Data From the Open-Label Extension of the U-ACTIVATE Study.
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Panaccione Remo, Colombel Jean-Frédéric, Dubinsky Marla, Ma Christopher, Kujawski Michelle, Cheng Erica, Dubcenco Elena, Ogholikhan Sina, Barrachina Elena Marced, Hisamatsu Tadakazu
Аннотация
BACKGROUND AND AIMS: Upadacitinib (UPA) is a Janus kinase inhibitor approved for moderately to severely active ulcerative colitis (UC). Patients may discontinue and then restart UPA treatment or require dose adjustment; however, the impact on overall efficacy of treatment interruption or dose escalation is not fully characterized. This analysis of the U-ACTIVATE (NCT03006068) open-label extension (OLE) study evaluated the efficacy of UPA retreatment after UPA withdrawal or dose escalation during UPA maintenance following a loss of response in patients with UC.
METHODS: Patients who responded to 8 weeks of UPA 45 mg induction therapy were rerandomized to placebo, UPA 15 mg (UPA15), or 30 mg (UPA30) in the 52-week U-ACHIEVE (NCT02819635) maintenance study. Patients who subsequently lost response on placebo during maintenance could enter the U-ACTIVATE OLE and were retreated with UPA at a 15 mg dose (UPA retreatment group); patients who lost response on maintenance UPA15 continued UPA15 during the OLE. Patients who lost response on UPA15 during the OLE and met prespecified criteria were escalated to UPA30. Clinical and endoscopic remissions were assessed through week 144. Safety was not assessed in this analysis but has been reported previously.
RESULTS: The UPA retreatment group enrolled 110 patients; 57 remained on UPA15 (UPA15OLE→UPA15) and 47 were escalated to UPA30 (UPA15OLE→UPA30) by week 144. A total of 39 patients lost response on maintenance UPA15 and entered the OLE on UPA30 (UPA15Maint→UPA30). At week 144, the following proportion of patients achieved clinical remission per adapted Mayo score and endoscopic remission, respectively: UPA15OLE→UPA15: 76.3% and 33.3%, UPA15OLE→UPA30: 61.1% and 56.4%, and UPA15Maint→UPA30: 43.5% and 40.7%.
CONCLUSION: In patients with UC, clinical and endoscopic efficacy could be recaptured following UPA retreatment or dose escalation in the U-ACTIVATE OLE.
METHODS: Patients who responded to 8 weeks of UPA 45 mg induction therapy were rerandomized to placebo, UPA 15 mg (UPA15), or 30 mg (UPA30) in the 52-week U-ACHIEVE (NCT02819635) maintenance study. Patients who subsequently lost response on placebo during maintenance could enter the U-ACTIVATE OLE and were retreated with UPA at a 15 mg dose (UPA retreatment group); patients who lost response on maintenance UPA15 continued UPA15 during the OLE. Patients who lost response on UPA15 during the OLE and met prespecified criteria were escalated to UPA30. Clinical and endoscopic remissions were assessed through week 144. Safety was not assessed in this analysis but has been reported previously.
RESULTS: The UPA retreatment group enrolled 110 patients; 57 remained on UPA15 (UPA15OLE→UPA15) and 47 were escalated to UPA30 (UPA15OLE→UPA30) by week 144. A total of 39 patients lost response on maintenance UPA15 and entered the OLE on UPA30 (UPA15Maint→UPA30). At week 144, the following proportion of patients achieved clinical remission per adapted Mayo score and endoscopic remission, respectively: UPA15OLE→UPA15: 76.3% and 33.3%, UPA15OLE→UPA30: 61.1% and 56.4%, and UPA15Maint→UPA30: 43.5% and 40.7%.
CONCLUSION: In patients with UC, clinical and endoscopic efficacy could be recaptured following UPA retreatment or dose escalation in the U-ACTIVATE OLE.