Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment
Abstract Background and Aim Pouchitis is a common complication after restorative ileal pouch–anal anastomosis following proctocolectomy for ulcerative colitis. Antibiotic‐dependent or antibiotic‐refractory chronic pouchitis (CP), which is a common cause of pouch failure affecting 15–20% of patients,...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-12-01
|
| Series: | JGH Open |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/jgh3.13000 |
| _version_ | 1797371669863464960 |
|---|---|
| author | Emi Khoo Andrew Lee Teresa Neeman Yoon‐Kyo An Jakob Begun |
| author_facet | Emi Khoo Andrew Lee Teresa Neeman Yoon‐Kyo An Jakob Begun |
| author_sort | Emi Khoo |
| collection | DOAJ |
| description | Abstract Background and Aim Pouchitis is a common complication after restorative ileal pouch–anal anastomosis following proctocolectomy for ulcerative colitis. Antibiotic‐dependent or antibiotic‐refractory chronic pouchitis (CP), which is a common cause of pouch failure affecting 15–20% of patients, is challenging to treat. The efficacy of second‐line immunomodulator and biologic therapy remains poorly defined. We present a pooled analysis of real‐world efficacy data from peer‐reviewed full‐text manuscripts, focusing on immunomodulator and biologic therapies in CP. Methods Embase and PubMed databases were searched for full‐text articles describing the treatment of CP. We performed a systematic review and pooled analysis of published studies to assess the efficacy of immunomodulators, including thiopurines and methotrexate, and biologics including antitumor necrosis factor, anti‐integrin, and interleukin‐12/23 antagonists. Clinical and endoscopic response and remission rates were combined for pooled analyses. Rates of treatment discontinuation and safety were also assessed. Results Pooled analysis comprised 20 full‐text articles (485 patients). Overall clinical response rate was 46% (95% CI: 35–59%) and clinical remission rate was 35% (95% CI: 21–52%). Overall endoscopic response and remission rates were 41% (95% CI: 18–68%) and 15% (95% CI: 5–39%), respectively. Individual agents' safety profile was reassuring, with vedolizumab being the most favorable. Conclusion The real‐world efficacy data of immunomodulators in the treatment of CP is insufficient. Vedolizumab and ustekinumab appeared effective and safe for CP, whereas anti‐TNFs showed higher rates of adverse events. The high heterogeneity within the studies is attributed to the real‐world study design, obfuscating drug efficacy comparisons across the studies. Further studies are required to define the comparative effectiveness of available treatments of CP. |
| first_indexed | 2024-03-08T18:25:16Z |
| format | Article |
| id | doaj.art-fcdab684d14244e8ae2ed1c958f9cc67 |
| institution | Directory Open Access Journal |
| issn | 2397-9070 |
| language | English |
| last_indexed | 2024-03-08T18:25:16Z |
| publishDate | 2023-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | JGH Open |
| spelling | doaj.art-fcdab684d14244e8ae2ed1c958f9cc672023-12-30T16:05:16ZengWileyJGH Open2397-90702023-12-0171289990710.1002/jgh3.13000Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatmentEmi Khoo0Andrew Lee1Teresa Neeman2Yoon‐Kyo An3Jakob Begun4Mater Hospital Brisbane Brisbane Queensland AustraliaMater Hospital Brisbane Brisbane Queensland AustraliaBiology Data Science Institute Australian National University Canberra Australian Capital Territory AustraliaMater Hospital Brisbane Brisbane Queensland AustraliaMater Hospital Brisbane Brisbane Queensland AustraliaAbstract Background and Aim Pouchitis is a common complication after restorative ileal pouch–anal anastomosis following proctocolectomy for ulcerative colitis. Antibiotic‐dependent or antibiotic‐refractory chronic pouchitis (CP), which is a common cause of pouch failure affecting 15–20% of patients, is challenging to treat. The efficacy of second‐line immunomodulator and biologic therapy remains poorly defined. We present a pooled analysis of real‐world efficacy data from peer‐reviewed full‐text manuscripts, focusing on immunomodulator and biologic therapies in CP. Methods Embase and PubMed databases were searched for full‐text articles describing the treatment of CP. We performed a systematic review and pooled analysis of published studies to assess the efficacy of immunomodulators, including thiopurines and methotrexate, and biologics including antitumor necrosis factor, anti‐integrin, and interleukin‐12/23 antagonists. Clinical and endoscopic response and remission rates were combined for pooled analyses. Rates of treatment discontinuation and safety were also assessed. Results Pooled analysis comprised 20 full‐text articles (485 patients). Overall clinical response rate was 46% (95% CI: 35–59%) and clinical remission rate was 35% (95% CI: 21–52%). Overall endoscopic response and remission rates were 41% (95% CI: 18–68%) and 15% (95% CI: 5–39%), respectively. Individual agents' safety profile was reassuring, with vedolizumab being the most favorable. Conclusion The real‐world efficacy data of immunomodulators in the treatment of CP is insufficient. Vedolizumab and ustekinumab appeared effective and safe for CP, whereas anti‐TNFs showed higher rates of adverse events. The high heterogeneity within the studies is attributed to the real‐world study design, obfuscating drug efficacy comparisons across the studies. Further studies are required to define the comparative effectiveness of available treatments of CP.https://doi.org/10.1002/jgh3.13000biologic therapieschronic pouchitisimmunomodulator |
| spellingShingle | Emi Khoo Andrew Lee Teresa Neeman Yoon‐Kyo An Jakob Begun Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment JGH Open biologic therapies chronic pouchitis immunomodulator |
| title | Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment |
| title_full | Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment |
| title_fullStr | Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment |
| title_full_unstemmed | Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment |
| title_short | Comprehensive systematic review and pooled analysis of real‐world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment |
| title_sort | comprehensive systematic review and pooled analysis of real world studies evaluating immunomodulator and biologic therapies for chronic pouchitis treatment |
| topic | biologic therapies chronic pouchitis immunomodulator |
| url | https://doi.org/10.1002/jgh3.13000 |
| work_keys_str_mv | AT emikhoo comprehensivesystematicreviewandpooledanalysisofrealworldstudiesevaluatingimmunomodulatorandbiologictherapiesforchronicpouchitistreatment AT andrewlee comprehensivesystematicreviewandpooledanalysisofrealworldstudiesevaluatingimmunomodulatorandbiologictherapiesforchronicpouchitistreatment AT teresaneeman comprehensivesystematicreviewandpooledanalysisofrealworldstudiesevaluatingimmunomodulatorandbiologictherapiesforchronicpouchitistreatment AT yoonkyoan comprehensivesystematicreviewandpooledanalysisofrealworldstudiesevaluatingimmunomodulatorandbiologictherapiesforchronicpouchitistreatment AT jakobbegun comprehensivesystematicreviewandpooledanalysisofrealworldstudiesevaluatingimmunomodulatorandbiologictherapiesforchronicpouchitistreatment |