Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis
Background: Effective management of patients with acute severe ulcerative colitis (ASUC) is a major challenge and there remains a paucity of available maintenance treatment options after efficacious cyclosporin induction therapy. Objectives: We investigated the long-term effectiveness and safety of...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2024-01-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/17562848231218555 |
| _version_ | 1797371352476286976 |
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| author | Francesco Vitali Timo Rath Entcho Klenske Anna-Lena Vögele Ingo Ganzleben Sebastian Zundler Deike Strobel Carol Geppert Arndt Hartmann Markus F. Neurath Raja Atreya |
| author_facet | Francesco Vitali Timo Rath Entcho Klenske Anna-Lena Vögele Ingo Ganzleben Sebastian Zundler Deike Strobel Carol Geppert Arndt Hartmann Markus F. Neurath Raja Atreya |
| author_sort | Francesco Vitali |
| collection | DOAJ |
| description | Background: Effective management of patients with acute severe ulcerative colitis (ASUC) is a major challenge and there remains a paucity of available maintenance treatment options after efficacious cyclosporin induction therapy. Objectives: We investigated the long-term effectiveness and safety of cyclosporin and ustekinumab combination therapy in patients with steroid refractory ASUC. Design: Monocentric, prospective study. Methods: We included patients with steroid refractory ASUC with multiple failed prior advanced therapies, who were treated with cyclosporin and ustekinumab combination therapy. Results: Among the 11 included patients, 10 had prior failure to infliximab and 8 failed at least three previous biological therapies. The mean baseline Mayo and Lichtiger scores were 10.9 (9–12) and 13.3 (11–14), respectively. Ustekinumab was initiated 3.2 weeks (1–8) after initiation of cyclosporin treatment and combination therapy was continued for a mean of 11.5 (4–20) weeks. Clinical response was achieved in six patients at week 16 and clinical steroid-free clinical remission in five patients at week 48. Endoscopic remission was achieved in five patients at week 16 and together with histological remission in five patients at week 52. Intestinal ultrasound demonstrated mean bowel wall thickening in the sigmoid colon of 5.5 mm at baseline and 3.5 mm at week 52, respectively. Two patients had to undergo colectomy (mean 4.5 months, range 3–6) and three stopped ustekinumab therapy due to ineffectiveness. Overall, combination therapy was well tolerated. Conclusion: Combination of cyclosporin and ustekinumab therapy allowed nearly half of ASUC patients to reach clinical and endoscopic remission after 52 weeks, warranting further studies. Trial registration: Not applicable. |
| first_indexed | 2024-03-08T18:18:34Z |
| format | Article |
| id | doaj.art-6893d39668f04c80b05d2913832cad4b |
| institution | Directory Open Access Journal |
| issn | 1756-2848 |
| language | English |
| last_indexed | 2024-03-08T18:18:34Z |
| publishDate | 2024-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-6893d39668f04c80b05d2913832cad4b2023-12-31T06:03:47ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482024-01-011710.1177/17562848231218555Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitisFrancesco VitaliTimo RathEntcho KlenskeAnna-Lena VögeleIngo GanzlebenSebastian ZundlerDeike StrobelCarol GeppertArndt HartmannMarkus F. NeurathRaja AtreyaBackground: Effective management of patients with acute severe ulcerative colitis (ASUC) is a major challenge and there remains a paucity of available maintenance treatment options after efficacious cyclosporin induction therapy. Objectives: We investigated the long-term effectiveness and safety of cyclosporin and ustekinumab combination therapy in patients with steroid refractory ASUC. Design: Monocentric, prospective study. Methods: We included patients with steroid refractory ASUC with multiple failed prior advanced therapies, who were treated with cyclosporin and ustekinumab combination therapy. Results: Among the 11 included patients, 10 had prior failure to infliximab and 8 failed at least three previous biological therapies. The mean baseline Mayo and Lichtiger scores were 10.9 (9–12) and 13.3 (11–14), respectively. Ustekinumab was initiated 3.2 weeks (1–8) after initiation of cyclosporin treatment and combination therapy was continued for a mean of 11.5 (4–20) weeks. Clinical response was achieved in six patients at week 16 and clinical steroid-free clinical remission in five patients at week 48. Endoscopic remission was achieved in five patients at week 16 and together with histological remission in five patients at week 52. Intestinal ultrasound demonstrated mean bowel wall thickening in the sigmoid colon of 5.5 mm at baseline and 3.5 mm at week 52, respectively. Two patients had to undergo colectomy (mean 4.5 months, range 3–6) and three stopped ustekinumab therapy due to ineffectiveness. Overall, combination therapy was well tolerated. Conclusion: Combination of cyclosporin and ustekinumab therapy allowed nearly half of ASUC patients to reach clinical and endoscopic remission after 52 weeks, warranting further studies. Trial registration: Not applicable.https://doi.org/10.1177/17562848231218555 |
| spellingShingle | Francesco Vitali Timo Rath Entcho Klenske Anna-Lena Vögele Ingo Ganzleben Sebastian Zundler Deike Strobel Carol Geppert Arndt Hartmann Markus F. Neurath Raja Atreya Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis Therapeutic Advances in Gastroenterology |
| title | Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis |
| title_full | Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis |
| title_fullStr | Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis |
| title_full_unstemmed | Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis |
| title_short | Long-term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid-refractory acute severe ulcerative colitis |
| title_sort | long term outcomes of cyclosporin induction and ustekinumab maintenance combination therapy in patients with steroid refractory acute severe ulcerative colitis |
| url | https://doi.org/10.1177/17562848231218555 |
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