Article Text
Abstract
Background and aims In the UK, treatments for patients with moderately to severely active ulcerative colitis who have an inadequate response to conventional therapies comprise four biological therapies—the tumour necrosis factor inhibitor (TNFi) agents adalimumab, golimumab and infliximab and the anti-integrin vedolizumab—and an orally administered small molecule therapy, tofacitinib. However, there have been few head-to-head studies of these therapies. This study aimed to compare the clinical and cost-effectiveness of tofacitinib with biological therapies.
Methods A systematic literature review was conducted to identify all relevant randomised controlled trial (RCT) evidence. Clinical response, clinical remission and serious infection rates were synthesised using network meta-analysis (NMA). The results were used to compare the cost-effectiveness of tofacitinib and biologics with conventional therapy, using a Markov model, which incorporated lifetime costs and consequences of treatment from a UK National Health Service perspective. Analyses were conducted separately for TNFi-naïve and TNFi-exposed populations.
Results Seventeen RCTs were used in the NMAs. There were no statistically significant differences among biological therapies and tofacitinib for either TNFi-naïve or TNFi-exposed patients. In TNFi-naïve patients, all therapies were more efficacious than placebo. In TNFi-exposed patients, only tofacitinib was significantly more efficacious than placebo as induction therapy, and only tofacitinib and vedolizumab were significantly more efficacious than placebo as maintenance therapies. There were no significant differences in serious infection rates among therapies. The incremental cost-effectiveness ratios for tofacitinib versus conventional therapy were £21 338 and £22 816 per quality-adjusted life year (QALY) in the TNFi-naïve and TNFi-exposed populations, respectively. TNFi therapies were dominated or extendedly dominated in both populations. Compared with vedolizumab, tofacitinib was associated with a similar number of QALYs, at a lower cost.
Conclusion Tofacitinib is an efficacious treatment for moderately to severely active ulcerative colitis and is likely to be a cost-effective use of NHS resources.
- tofacitinib
- biologic therapy
- inflammatory bowel disease
- clinical response and remission
- indirect comparison
- cost effectiveness analysis
- quality adjusted life year
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Footnotes
Contributors All authors contributed to the protocol for this work. EW performed the systematic review, data extraction and critical appraisal of included studies. EW, CL, LMS and NB selected results for inclusion. CLR, CL and LMS planned the statistical analyses. CLR performed the network meta-analyses. AD and CL designed the economic evaluation. AD built the cost-effectiveness model and AD and LMS performed the analyses. LMS, CL and AD wrote the first draft of the manuscript, which was subsequently edited by all authors, who have approved the final version. All authors had full access to the data (including statistical results and tables) and take responsibility for the integrity of the data and accuracy of the analysis. CL will act as guarantor.
Funding This study was funded by Pfizer UK.
Competing interests AD, LMS and EW are employees of Symmetron Ltd, which received funding from Pfizer UK for this project. CLR received funding for this project from Symmetron Ltd. CL and NB are employees of Pfizer UK.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.