Thioguanine is Effective as Maintenance Therapy for Inflammatory Bowel Disease: A Prospective Multicentre Registry Study
Simsek, Melek; Schepers, Femke; Kaplan, Sigal; Van Asseldonk, Dirk; Van Boeckel, Petra; Boekema, Paul; Dijkstra, Gerard; Fidder, Herma; Gisbertz, Ingrid; Hoentjen, Frank; Jharap, Bindia; Kubben, Frank; De Leest, Marleen; Meijssen, Maarten; Petrak, Ana; Van De Poel, Else; Russel, Maurice; Van Bodegraven, Adriaan A.; Mulder, Chris J.J.; De Boer, Nanne
(2023) Journal of Crohn's & Colitis, volume 17, issue 6, pp. 933 - 942
(Article)
Abstract
Background and Aims: Thioguanine is a well-tolerated and effective therapy for inflammatory bowel disease [IBD] patients. Prospective effectiveness data are needed to substantiate the role of thioguanine as a maintenance therapy for IBD. Methods: IBD patients who previously failed azathioprine or mercaptopurine and initiated thioguanine were prospectively followed for 12
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months starting when corticosteroid-free clinical remission was achieved (Harvey-Bradshaw Index [HBI] ≤ 4 or Simple Clinical Colitis Activity Index [SCCAI] ≤ 2). The primary endpoint was corticosteroid-free clinical remission throughout 12 months. Loss of clinical remission was defined as SCCAI > 2 or HBI > 4, need of surgery, escalation of therapy, initiation of corticosteroids or study discontinuation. Additional endpoints were adverse events, drug survival, physician global assessment [PGA] and quality of life [QoL]. Results: Sustained corticosteroid-free clinical remission at 3, 6 or 12 months was observed in 75 [69%], 66 [61%] and 49 [45%] of 108 patients, respectively. Thioguanine was continued in 86 patients [80%] for at least 12 months. Loss of response [55%] included escalation to biologicals in 15%, corticosteroids in 10% and surgery in 3%. According to PGA scores, 82% of patients were still in remission after 12 months and QoL scores remained stable. Adverse events leading to discontinuation were reported in 11%, infections in 10%, myelo- and hepatotoxicity each in 6%, and portal hypertension in 1% of patients. Conclusion: Sustained corticosteroid-free clinical remission over 12 months was achieved in 45% of IBD patients on monotherapy with thioguanine. A drug continuation rate of 80%, together with favourable PGA and QoL scores, underlines the tolerability and effectiveness of thioguanine for IBD.
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Keywords: Azathioprine/therapeutic use, Colitis/chemically induced, Humans, Immunosuppressive Agents/adverse effects, Inflammatory Bowel Diseases/drug therapy, Mercaptopurine/therapeutic use, Prospective Studies, Quality of Life, Thioguanine/therapeutic use, General Medicine, Journal Article, Multicenter Study
ISSN: 1873-9946
Publisher: Elsevier
Note: Publisher Copyright: © 2023 The Author(s). Published by Oxford University Press on behalf of European Crohn's and Colitis Organisation.
(Peer reviewed)