Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jul 30;6(1):e000302.
doi: 10.1136/bmjgast-2019-000302. eCollection 2019.

Tofacitinib for the treatment of moderately to severely active ulcerative colitis: a systematic review, network meta-analysis and economic evaluation

Christoph Lohan  1 , Alex Diamantopoulos  2 , Corinne LeReun  3 , Emily Wright  2 , Natalie Bohm  1 , Laura Marie Sawyer  2
Affiliations

Tofacitinib for the treatment of moderately to severely active ulcerative colitis: a systematic review, network meta-analysis and economic evaluation

Christoph Lohan et al. BMJ Open Gastroenterol. .

Erratum in

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.

Keywords: biologic therapy; clinical response and remission; cost effectiveness analysis; indirect comparison; inflammatory bowel disease; quality adjusted life year; tofacitinib.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Schematic of cost-effectiveness model. *Patients transition to the postsurgery states following either emergency or elective colectomy. CC, colectomy complications; UC, ulcerative colitis.
Figure 2
Figure 2
PRISMA flow diagram showing included and excluded studies. *SLRs were used for bibliography checks and then excluded. †UC-SUCCESS compared infliximab with azathioprine. This study was included in the safety NMA but excluded from the efficacy analysis due to differences in outcome definition and time point of evaluation. NMA, network meta-analysis; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; SLR, systematic literature review.
See this image and copyright information in PMC

References

    1. Molodecky NA, Soon IS, Rabi DM, et al. . Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on Systematic review. Gastroenterology 2012;142:e42; quiz e30:46–54. 10.1053/j.gastro.2011.10.001 - DOI - PubMed
    1. Ng SC, Shi HY, Hamidi N, et al. . Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet 2018;390:2769–78. 10.1016/S0140-6736(17)32448-0 - DOI - PubMed
    1. Ungaro R, Mehandru S, Allen PB, et al. . Ulcerative colitis. Lancet 2017;389:1756–70. 10.1016/S0140-6736(16)32126-2 - DOI - PMC - PubMed
    1. Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med 2011;365:1713–25. 10.1056/NEJMra1102942 - DOI - PubMed
    1. Yarlas A, Rubin DT, Panés J, et al. . Burden of ulcerative colitis on functioning and well-being: a systematic literature review of the SF-36® health survey. J Crohns Colitis 2018;12:600–9. 10.1093/ecco-jcc/jjy024 - DOI - PubMed

LinkOut - more resources