Systematic review and network meta-analysis of treatment for moderate-to-severe ulcerative colitis

Trigo-Vicente, Cristina; Gimeno‐Ballester, Vicente; García-López, Santiago; Val, Alejandro López-Del

doi:10.1007/s11096-018-0743-4

Cited by 36 publications

(38 citation statements)

References 43 publications

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“…Results of our NMA are similar to those of other recently published NMAs of the same comparators, despite some noteworthy differences in terms of design. Bonovas et al 49 and Trigo-Vicente et al 50 focused only on TNFi-naïve patients, whereas Singh et al 51 evaluated comparative induction phase efficacy in both TNFi-naïve and TNFi-exposed groups separately. All three NMAs used the stricter ‘remission’ outcome from the OCTAVE trials25 rather than ‘clinical remission’, an outcome more comparable to other RCTs.…”

Section: Discussionmentioning

confidence: 99%

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

Lohan

Diamantopoulos²,

LeReun

et al. 2019

BMJ Open Gastroenterol

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Background and aimsIn 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.MethodsA 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.ResultsSeventeen 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.ConclusionTofacitinib is an efficacious treatment for moderately to severely active ulcerative colitis and is likely to be a cost-effective use of NHS resources.

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Section: Discussionmentioning

confidence: 99%

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

Lohan

Diamantopoulos²,

LeReun

et al. 2019

BMJ Open Gastroenterol

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“…The drugs’ efficacy data were provided by a fixed-model network meta-analysis 18. Efficacy outcomes were clinical remission, clinical response and mucosal healing for induction therapy, and clinical remission, mucosal healing and sustained clinical remission for maintenance therapy.…”

Section: Methodsmentioning

confidence: 99%

Cost-effectiveness analysis of infliximab, adalimumab, golimumab, vedolizumab and tofacitinib for moderate to severe ulcerative colitis in Spain

Trigo-Vicente¹,

Gimeno‐Ballester

Val

2019

Eur J Hosp Pharm

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ObjectiveDespite the biological drugs, the treatment of moderate to severe ulcerative colitis is still a challenge, particularly in resource-limited settings. The aim of this study was to assess the efficiency of biological drugs and tofacitinib for moderate to severe ulcerative colitis in the Spanish context.MethodsA Markov model was built to simulate the progression of moderate to severe ulcerative colitis in a cohort of patients. The model used a time horizon of 10 years. The perspective chosen was the National Health Service, with a discount rate of 3%, and a threshold of €30,000/quality adjusted life-year (QALY). It carried out a one-way sensitivity analysis and probabilistic sensitivity analysis.ResultsThe comparison of infliximab with adalimumab and golimumab estimated an incremental cost-effectiveness ratio (ICER) of €43,928.07/QALY and €31,340.69/QALY, with a difference of − 0.43 and − 0.82 QALY, respectively. Vedolizumab vs infliximab achieved an ICER of €122,890.19/QALY with a gain of 0.46 QALY. The comparison of infliximab with tofacitinib yielded an estimated ICER of €270,503.19/QALY, with a slight gain in QALY (0.16). The one-way sensitivity analysis showed a robust study.ConclusionFor a threshold of €30,000/QALY, adalimumab was the most cost-effective treatment versus infliximab for moderate to severe ulcerative colitis in Spain.

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“…For both of these disease processes, passive antibody therapy may offer not only control of disease but possible complete remission from mucosal damage. 263,264 Adalimumab (two formulations: Humira and Amjevita) is a recombinant human Mab (IgG1) with specificity to tumor necrosis factor alpha (TNF-a). Both forms are FDA approved to treat Crohn's disease as well as multiple types of rheumatoid arthritis.…”

Section: Inflammatory Bowel Diseasementioning

confidence: 99%

Passive Monoclonal and Polyclonal Antibody Therapies

Pelletier¹,

Mukhtar²

2020

Immunologic Concepts in Transfusion Medicine

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Systematic review and network meta-analysis of treatment for moderate-to-severe ulcerative colitis

Cited by 36 publications

References 43 publications

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

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

Cost-effectiveness analysis of infliximab, adalimumab, golimumab, vedolizumab and tofacitinib for moderate to severe ulcerative colitis in Spain

Passive Monoclonal and Polyclonal Antibody Therapies

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