Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis
Harpreet Singh,1 Liam Wilson,2 Tom Tencer,3 Jinender Kumar3 1Health Economics & Market Access (HEMA), Amaris Consulting Ltd, Toronto, ON, Canada; 2Health Economics & Market Access (HEMA), Amaris Consulting Ltd, Shanghai, People’s Republic of China; 3Bristol Myers Squibb, Princeton, NJ, USACo...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-02-01
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| Series: | ClinicoEconomics and Outcomes Research |
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| Online Access: | https://www.dovepress.com/systematic-literature-review-of-real-world-evidence-on-dose-escalation-peer-reviewed-fulltext-article-CEOR |
| _version_ | 1797894480881254400 |
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| author | Singh H Wilson L Tencer T Kumar J |
| author_facet | Singh H Wilson L Tencer T Kumar J |
| author_sort | Singh H |
| collection | DOAJ |
| description | Harpreet Singh,1 Liam Wilson,2 Tom Tencer,3 Jinender Kumar3 1Health Economics & Market Access (HEMA), Amaris Consulting Ltd, Toronto, ON, Canada; 2Health Economics & Market Access (HEMA), Amaris Consulting Ltd, Shanghai, People’s Republic of China; 3Bristol Myers Squibb, Princeton, NJ, USACorrespondence: Jinender Kumar, Global HEOR, Bristol Myers Squibb, 100 Nassau Park Blvd #300, Princeton, NJ, 08540, USA, Tel +1-609-302-7630, Email Jinender.Kumar@bms.comBackground: Currently approved biologic therapies for moderate-to-severe ulcerative colitis have well-established efficacy. However, many patients fail to respond or lose response, leading to dose escalation or treatment switching.Objective: We sought to identify real-world evidence on dose escalation and treatment switching and associated clinical and economic outcomes among adults with ulcerative colitis treated with infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, or tofacitinib.Methods: We conducted a systematic search of Embase, MEDLINE (up to 26 August 2020), and conference proceedings (2017− 2020) for studies in adults with ulcerative colitis to assess clinical response and remission, colectomy, adverse events, and economic outcomes related to dose escalation and treatment switching.Results: In 56 studies, dose escalation and treatment switching involving infliximab and/or adalimumab were most frequently investigated. Rates of clinical response after dose escalation were 20– 95% (1.8– 36 months), clinical remission rates were 10– 94% (1.8– 36 months), colectomy rates were 0– 33% (12– 38 months), and adverse event rates were 0– 18%. Treatment switching rates in 21 studies were 4– 70% over 3– 62 months, with switch due to loss of response rates of 4– 35% over 12– 62 months (7 studies). Up to 35% of patients underwent colectomy 12− 120 weeks after switching, and 13– 38% experienced adverse events. Data relating to economic outcomes were limited to tumor necrosis factor inhibitors, but demonstrated increased direct costs associated with both dose escalation and treatment switching.Conclusion: Dose escalation and treatment switching are common with existing therapies. However, clinical response and remission rates vary, and a proportion of patients fail to achieve optimal clinical and economic outcomes. This highlights the need for more efficacious and durable treatments for patients with moderate-to-severe ulcerative colitis.Keywords: ulcerative colitis, real-world evidence, systematic literature review, biologic therapies, tofacitinib |
| first_indexed | 2024-04-10T07:09:43Z |
| format | Article |
| id | doaj.art-b641f6c033cc4da496160cb0a8ff9a57 |
| institution | Directory Open Access Journal |
| issn | 1178-6981 |
| language | English |
| last_indexed | 2024-04-10T07:09:43Z |
| publishDate | 2023-02-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | ClinicoEconomics and Outcomes Research |
| spelling | doaj.art-b641f6c033cc4da496160cb0a8ff9a572023-02-26T15:41:34ZengDove Medical PressClinicoEconomics and Outcomes Research1178-69812023-02-01Volume 1512513881822Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative ColitisSingh HWilson LTencer TKumar JHarpreet Singh,1 Liam Wilson,2 Tom Tencer,3 Jinender Kumar3 1Health Economics & Market Access (HEMA), Amaris Consulting Ltd, Toronto, ON, Canada; 2Health Economics & Market Access (HEMA), Amaris Consulting Ltd, Shanghai, People’s Republic of China; 3Bristol Myers Squibb, Princeton, NJ, USACorrespondence: Jinender Kumar, Global HEOR, Bristol Myers Squibb, 100 Nassau Park Blvd #300, Princeton, NJ, 08540, USA, Tel +1-609-302-7630, Email Jinender.Kumar@bms.comBackground: Currently approved biologic therapies for moderate-to-severe ulcerative colitis have well-established efficacy. However, many patients fail to respond or lose response, leading to dose escalation or treatment switching.Objective: We sought to identify real-world evidence on dose escalation and treatment switching and associated clinical and economic outcomes among adults with ulcerative colitis treated with infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, or tofacitinib.Methods: We conducted a systematic search of Embase, MEDLINE (up to 26 August 2020), and conference proceedings (2017− 2020) for studies in adults with ulcerative colitis to assess clinical response and remission, colectomy, adverse events, and economic outcomes related to dose escalation and treatment switching.Results: In 56 studies, dose escalation and treatment switching involving infliximab and/or adalimumab were most frequently investigated. Rates of clinical response after dose escalation were 20– 95% (1.8– 36 months), clinical remission rates were 10– 94% (1.8– 36 months), colectomy rates were 0– 33% (12– 38 months), and adverse event rates were 0– 18%. Treatment switching rates in 21 studies were 4– 70% over 3– 62 months, with switch due to loss of response rates of 4– 35% over 12– 62 months (7 studies). Up to 35% of patients underwent colectomy 12− 120 weeks after switching, and 13– 38% experienced adverse events. Data relating to economic outcomes were limited to tumor necrosis factor inhibitors, but demonstrated increased direct costs associated with both dose escalation and treatment switching.Conclusion: Dose escalation and treatment switching are common with existing therapies. However, clinical response and remission rates vary, and a proportion of patients fail to achieve optimal clinical and economic outcomes. This highlights the need for more efficacious and durable treatments for patients with moderate-to-severe ulcerative colitis.Keywords: ulcerative colitis, real-world evidence, systematic literature review, biologic therapies, tofacitinibhttps://www.dovepress.com/systematic-literature-review-of-real-world-evidence-on-dose-escalation-peer-reviewed-fulltext-article-CEORulcerative colitisreal-world evidencesystematic literature reviewbiologic therapiestofacitinib |
| spellingShingle | Singh H Wilson L Tencer T Kumar J Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis ClinicoEconomics and Outcomes Research ulcerative colitis real-world evidence systematic literature review biologic therapies tofacitinib |
| title | Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis |
| title_full | Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis |
| title_fullStr | Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis |
| title_full_unstemmed | Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis |
| title_short | Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis |
| title_sort | systematic literature review of real world evidence on dose escalation and treatment switching in ulcerative colitis |
| topic | ulcerative colitis real-world evidence systematic literature review biologic therapies tofacitinib |
| url | https://www.dovepress.com/systematic-literature-review-of-real-world-evidence-on-dose-escalation-peer-reviewed-fulltext-article-CEOR |
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