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Abreu, Maria T.; Panaccione, Remo; Vermeire, Séverine; Rubin, David T.; Mehra, Dimpy; Wu, Hsiuanlin; Osterman, Mark T.; Ahmad, Harris A.; Jain, Anjali; Danese, Silvio
The American journal of gastroenterology, 10/2023, Letnik: 118, Številka: 10SJournal Article
Methods: This interim analysis of the TN OLE (cutoff: 10Jan2022) explored whether achieving endpoints at TN W52, examined by increasing objectivity, would impact the durability of symptomatic and clinical outcomes with continuous OZA tx up to OLE W94. Achievement of CRem at TN W52 had an incremental benefit over CRes at TN W52 for the maintenance of CRem and CS-free remission at OLE W94, but other endpoints of higher objectivity had no additional benefit (Table 1). Endpoints (increasing in objectivity) at TN W52 (OC analysis) Endpoint, % (n/N) CResa CRemb CS-free remissionc OLE W46 OLE W94 OLE W46 OLE W94 OLE W46 OLE W94 CResa (N=131) 95.9 (93/97) 91.4 (74/81) 72.2 (70/97) 69.1 (56/81) 70.1 (68/97) 67.9 (55/81) CRemb (N=83) 97.0 (64/66) 94.4 (51/54) 81.8 (54/66) 75.9 (41/54) 80.3 (53/66) 74.1 (40/54) Endoscopic improvement (MES ≤1; N=93) 97.3 (73/75) 95.2 (60/63) 78.7 (59/75) 73.0 (46/63) 77.3 (58/75) 71.4 (45/63) Complete endoscopic healing (MES=0; N=50) 97.6 (40/41) 90.9 (30/33) 82.9 (34/41) 69.7 (23/33) 80.5 (33/41) 66.7 (22/33) Histologic remission (Geboes index score < 2.0; N=68) 98.1 (51/52) 95.3 (41/43) 82.7 (43/52) 74.4 (32/43) 80.8 (42/52) 72.1 (31/43) Mucosal healing (MES ≤1 and Geboes index score < 2.0; N=61) 97.9 (46/47) 94.7 (36/38) 80.9 (38/47) 71.1 (27/38) 78.7 (37/47) 68.4 (26/38) Stringent mucosal healing (MES=0 and Geboes index score < 2.0; N=37) 96.6 (28/29) 91.3 (21/23) 79.3 (23/29) 65.2 (15/23) 75.9 (22/29) 60.9 (14/23) Denominators for the OC analysis were based on the numbers of pts who completed OLE W46 or OLE W94 and had data available for the endpoints in question. aClinical response: reduction from baseline in the 9-point Mayo score of ≥2 points and ≥35%, and a reduction from baseline in RBS of ≥1 point or an absolute RBS of ≤1 point. bClinical remission: RBS=0, SFS ≤1 point (and a decrease of ≥1 point from the baseline SFS), and endoscopy subscore ≤1 point. cCS-free remission:
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Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Vir: Osebne bibliografije
in: SICRIS
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