TY - JOUR
T1 - Ulcerative colitis remission status after induction with mesalazine predicts maintenance outcomes
T2 - The MOMENTUM trial
AU - On behalf of the Ulcerative Colitis Remission Study Group
AU - Rubin, David T.
AU - Bradette, Marc
AU - Gabalec, Libor
AU - Dobru, Daniela
AU - Márquez, Juan
AU - Inglis, Susi
AU - Magee, Elizabeth
AU - Solomon, Dory
AU - D'Haens, Geert
AU - Baert, Filip
AU - D'Heygere, Francois
AU - Marshall, John
AU - Ostro, Michael
AU - Pare, Pierre
AU - Feris, Jacobo
AU - Juliao, Fabian
AU - Orozco, Alejandro
AU - Benes, Marek
AU - Compel, Vladimir
AU - Douda, Ladislav
AU - Hejcman, Jan
AU - Kozeluhova, Jana
AU - Lukas, Milan
AU - Nosek, Vladimir
AU - Tichy, Michal
AU - Vanasek, Tomas
AU - Bourreille, Arnaud
AU - Zerbib, Frank
AU - Kucharzik, Torsten
AU - Grenda, Andor
AU - Gurzo, Zoltan
AU - Pecsi, Gyula
AU - Szaloki, Tibor
AU - Banerjee, Rupa
AU - Bhandarkar, Prashant
AU - Chandra, Abhijit
AU - Goswami, Bhabadev
AU - Kalla, Mukesh
AU - Kolte, Sanjay
AU - Mehta, Rupesh Bhaidas
AU - Krishna, Palakurthi Murali
AU - Nijhawan, Sandeep
AU - Shenoy, K. T.
AU - Sood, Ajit
AU - Vishwanath Tantry, B.
AU - Thorat, Vinay
AU - Mulcahy, Hugh
AU - O'Morain, Colm
AU - Patchett, Stephen
AU - Loftus, Edward
N1 - Publisher Copyright:
© European Crohn's and Colitis Organisation 2016.
PY - 2016
Y1 - 2016
N2 - Background and Aims: This study assessed the efficacy of maintenance treatment with multimatrix mesalazine following achievement of complete or partial remission after induction treatment with high-dose multimatrix mesalazine. Methods: In this phase 3b/4, open-label, multicentre, prospective, single-arm study, patients with mild-to-moderate ulcerative colitis were treated with multimatrix mesalazine 4.8 g/day once daily for 8 weeks [induction phase]. At Week 8, those who achieved complete or partial remission, based on predefined clinical and endoscopic criteria, were eligible to receive 12 months of multimatrix mesalazine 2.4 g/day once daily maintenance therapy. The primary endpoint was the proportion of patients in complete remission at Month 12. Results: A total of 717 patients received induction treatment; 25.9% and 39.3% of patients achieved complete and partial remission, respectively, at Week 8. A total of 461 patients entered the maintenance phase. The likelihood of remaining in/achieving complete remission at Month 12 was higher for patients who entered the maintenance phase in complete remission compared with those who began maintenance in partial remission [47.8% vs 26.0%; p < 0.001]. At Month 12, mucosal healing [endoscopy score ≤ 1] was demonstrated in 76.4% [139/182] and 63.5% [176/277] of those who were in complete and partial remission, respectively, at the end of induction. Conclusion: Patients achieving complete remission before dose reduction were more likely to remain in remission at Month 12.
AB - Background and Aims: This study assessed the efficacy of maintenance treatment with multimatrix mesalazine following achievement of complete or partial remission after induction treatment with high-dose multimatrix mesalazine. Methods: In this phase 3b/4, open-label, multicentre, prospective, single-arm study, patients with mild-to-moderate ulcerative colitis were treated with multimatrix mesalazine 4.8 g/day once daily for 8 weeks [induction phase]. At Week 8, those who achieved complete or partial remission, based on predefined clinical and endoscopic criteria, were eligible to receive 12 months of multimatrix mesalazine 2.4 g/day once daily maintenance therapy. The primary endpoint was the proportion of patients in complete remission at Month 12. Results: A total of 717 patients received induction treatment; 25.9% and 39.3% of patients achieved complete and partial remission, respectively, at Week 8. A total of 461 patients entered the maintenance phase. The likelihood of remaining in/achieving complete remission at Month 12 was higher for patients who entered the maintenance phase in complete remission compared with those who began maintenance in partial remission [47.8% vs 26.0%; p < 0.001]. At Month 12, mucosal healing [endoscopy score ≤ 1] was demonstrated in 76.4% [139/182] and 63.5% [176/277] of those who were in complete and partial remission, respectively, at the end of induction. Conclusion: Patients achieving complete remission before dose reduction were more likely to remain in remission at Month 12.
KW - 5-aminosalicylic acid [5-ASA]
KW - Inflammatory bowel disease
KW - MOMENTUM
UR - http://www.scopus.com/inward/record.url?scp=84995664539&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84995664539&partnerID=8YFLogxK
U2 - 10.1093/ECCO-JCC/JJW049
DO - 10.1093/ECCO-JCC/JJW049
M3 - Article
C2 - 26908939
AN - SCOPUS:84995664539
SN - 1873-9946
VL - 10
SP - 925
EP - 933
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 8
ER -