PTH-072 Corticosteroid Dose Reduction in Ulcerative Colitis Patients Treated with Vedolizumab

IntroductionCorticosteroids (CS) are effective for the short-term treatment of patients (pts) with ulcerative colitis (UC), but serious side effects prohibit long-term use. In the GEMINI 1 study, a higher percentage of pts with moderately to severely active UC were in CS-free remission at week (wk) 52 with vedolizumab (VDZ) treatment than with placebo (PBO).1MethodsIn GEMINI 1, pts who responded to VDZ induction therapy at wk 6 were re-randomised to PBO or VDZ for 46 wks. From wk 6 onward, pts with clinical response discontinued CS use. We characterised CS dose reductions achieved with VDZ therapy in exploratory and post hoc analyses of pts with baseline (wk 0) CS use (≤30 mg/day prednisone or equivalent). Median CS dose over time, change from baseline CS dose, and CS-free status at wk 52 were summarised overall and by anti-tumour necrosis factor (anti-TNF) treatment (naïve or failure) history.ResultsOf pts with baseline CS use, 74% decreased their CS dose with VDZ treatment at week 52 (vs 57% with PBO) (Table). At wk 52, 56% of VDZ-treated pts were on ≤7.5 mg/day of CS (Table), and the median CS dose was 2.5 mg/day for VDZ-treated pts and 10.0 mg/day for PBO. Numerically higher percentages of VDZ-treated pts were CS-free for 90 and 180 consecutive days at wk 52 than PBO- treated pts. Similar trends were observed in the anti-TNF-naïve and anti-TNF-failure populations.Abstract PTH-072 Table 1CS Dose changes at Wk 52Wk 52Anti-TNF-NaïveAnti-TNF-FailureOverallPBOn = 40 b VDZa n = 82 b PBOn = 21 b VDZa n = 42 b PBOn = 67 b VDZa n = 140 b No. of Pts (%) CS dose increasedc 8 (20)4 (5)5 (24)2 (5)14 (21)10 (7) CS dose decreasedc 24 (60)63 (77)12 (57)33 (79)38 (57)104 (74) CS-free 10 (25)37 (45)3 (14)12 (29)13 (19)54 (39) Daily CS dose ≤ 7.5 mgc 13 (30)52 (63)9 (39)23 (51)23 (32)80 (56)a VDZ every 4 or 8 wks.b Pts on CS according to the interactive voice response system (IVRS) at screening and also on CS for UC at baseline (wk 0).c Pts on CS according to the IVRS at screening; anti-TNF-naïve: PBO n = 43, VDZ n = 83; anti-TNF-failure: PBO n = 23, VDZ n = 45; overall: PBO n = 72, VDZ n = 143. ConclusionNumerically greater reductions in CS use were achieved with VDZ maintenance therapy compared with PBO. At week 52, VDZ therapy was associated with numerically higher percentages of CS-free patients and patients who were CS-free for 90 or 180 consecutive days than PBO. Interpretation of these post hoc analyses, including the degree of dose reduction, is limited by differ