scholarly journals Cost-effectiveness analysis of treatment sequences containing tofacitinib for the treatment of rheumatoid arthritis in Spain

2020 ◽  
Vol 39 (10) ◽  
pp. 2919-2930 ◽  
Author(s):  
F. Navarro ◽  
J. M. Martinez-Sesmero ◽  
A. Balsa ◽  
C. Peral ◽  
M. Montoro ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
Cost Saving ◽  
Inadequate Response ◽  
Concomitant Treatment ◽  
Biological Therapies ◽  
Biological Drugs ◽  
Line Therapy ◽  
Treatment Sequences

Abstract Objective To assess the cost-effectiveness of tofacitinib-containing treatment sequences versus sequences containing only standard biological therapies in patients with moderate-to-severe rheumatoid arthritis (RA) after the failure of conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR population) and in patients previously treated with methotrexate (MTX) who show an inadequate response to second-line therapy with any tumour necrosis factor inhibitor (TNFi-IR population). Methods A patient-level microsimulation model estimated, from the perspective of the Spanish Public NHS, lifetime costs and quality-adjusted life years (QALY) for treatment sequences starting with tofacitinib (5 mg twice daily) followed by biological therapies versus sequences of biological treatments only. Concomitant treatment with MTX was considered. Model’s parameters comprised demographic and clinical inputs (initial Health Assessment Questionnaire [HAQ] score and clinical response to short- and long-term treatment). Efficacy was measured by means of HAQ score changes using mixed treatment comparisons and data from long-term extension (LTE) trials. Serious adverse events (SAEs) data were derived from the literature. Total cost estimation (€, 2018) included drug acquisition, parenteral administration, disease progression and SAE management. Results In the csDMARD-IR population, sequences starting with tofacitinib proved dominant options (more QALYs and lower costs) versus the corresponding sequences without tofacitinib. In the TNFi-IR population, first-line treatment with tofacitinib+MTX followed by scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX proved dominant versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX; and tofacitinib+MTX➔scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX versus scTocilizumab+MTX➔scAbatacept+MTX➔rituximab+MTX➔certolizumab+MTX was less effective but remained a cost-saving option. Conclusions Inclusion of tofacitinib seems a dominant strategy in moderate-to-severe RA patients after csDMARDs failure. Tofacitinib, as initial third-line therapy, proved a cost-saving strategy (€− 337,489/QALY foregone) in moderate-to-severe TNFi-IR RA patients. Key points• Therapeutical approach in rheumatoid arthritis (RA) consisted in sequences of several therapies during patient lifetime.• Treatment sequences initiating with tofacitinib followed by biological drugs provided higher health effects in csDMARDs-IR population, compared with sequences containing only biological drugs.• In both csDMARD-IR and TNFi-IR RA populations, initiating treatment with tofacitinib was associated to lower treatment costs for the Spanish National Health System.

scholarly journals Rituximab for the treatment of rheumatoid arthritis

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 23-29
Author(s):  
A Bagust ◽  
A Boland ◽  
J Hockenhull ◽  
N Fleeman ◽  
J Greenhalgh ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
Indirect Comparison ◽  
Comparison Method ◽  
Standards Of Care ◽  
Secondary Outcome ◽  
Inadequate Response ◽  
Single Technology Appraisal ◽  
Term Efficacy

This paper presents a summary of the evidence review group’s critical review of the evidence for the clinical effectiveness and cost-effectiveness of rituximab for the treatment of severe rheumatoid arthritis (RA) following failure of previous therapy, including one or more tumour necrosis factor-α inhibitors (TNFi), compared with current standards of care, based upon the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s clinical evidence came from one randomised, placebo-controlled, double-blind trial (REFLEX – Random Evaluation of Long-term Efficacy of Rituximab in Rheumatoid Arthritis) comparing rituximab plus methotrexate (MTX) with placebo plus MTX in 517 patients with long-standing refractory RA. Rituximab plus MTX was more effective than placebo plus MTX across a range of primary and secondary outcome measures, e.g. American College of Rheumatology (ACR) responses, Health Assessment Questionnaire (HAQ). However, this evidence cannot be used directly to address the manufacturer’s analysis of the decision problem because, in the REFLEX trial, rituximab was not compared with a relevant comparator (e.g. leflunomide or second or third TNFi). Long-term efficacy data for retreatment with rituximab are favourable, with an estimated mean time to retreatment of 307 days (n = 164). Evidence from a further five trials is presented as the basis for indirect comparisons with other disease-modifying antirheumatic drugs (DMARDs); however, it is not clear that all relevant clinical studies have been included in the indirect comparison exercise, the rationale for the choice of indirect comparison method adopted is unclear and the indirect comparison method used to adjust the ACR responses only uses a single value for the reference placebo. The submitted microsimulation Markov model was based upon the REFLEX trial. For the ‘NICE-recommended’ scenario and the ‘sequential TNFi’ scenario, the original submission reports incremental cost-effectiveness ratios (ICERs) of £14,690 and £11,601 per quality-adjusted life-year (QALY) gained respectively. After model assumptions were adjusted to more realistic estimates by the ERG, the ICERs for the NICE-recommended scenario and the sequential use of TNFi range from £37,002 to £80,198 per QALY gained and from £28,553 to £65,558 per QALY gained respectively. The guidance issued by NICE in August 2007 states that rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to or intolerance of other DMARDs including treatment with at least one TNFi therapy.

scholarly journals EP10 Hyperinflammatory syndrome in a patient with rheumatoid arthritis and COVID-19

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Melissa Ong ◽  
Mark Gibson ◽  
Gerald Coakley
Keyword(s):  
Rheumatoid Arthritis ◽  
Case Report ◽  
High Resolution ◽  
Critically Ill ◽  
Inflammatory Markers ◽  
Ground Glass ◽  
Successful Outcome ◽  
Biological Therapies ◽  
Oxygen Requirement

Abstract Case report - Introduction Severe acute respiratory coronavirus 2 (SARS-CoV-2) is a novel virus that can lead to an excessive immune activation and cytokine response known as Coronavirus disease 2019 (COVID-19) which predominantly affects the lungs. Patients with chronic inflammatory disease on biological immunosuppressive treatments may be at a higher risk of contracting SARS-CoV-2. However, it is yet to be determined whether immunomodulatory medications used in inflammatory diseases have protective capabilities against severe outcomes. Case report - Case description A 51-year old female with a 13-year history of rheumatoid arthritis (RA) presented to hospital with fever, exertional breathlessness, and a non-productive cough. She was diagnosed with seropositive erosive RA at the age of 38 and was on 6-monthly Rituximab infusions and Leflunomide on admission. She had relatively stable pulmonary fibrosis (diagnosed in 2010). Her chest CTs in 2010 and 2018 noted bilateral basal subpleural ground glass change with limited honeycombing and spirometry study revealed FEV1 of 2.2 (82% predicted), VC of 2.7 (87% predicted), DLCO of 7.0 (78% predicted) and kCO of 1.6 (78% predicted). On admission in March 2020, she was hypoxic (oxygen saturation of 88% in room air) and had raised inflammatory markers (CRP 341mg/dL, d-Dimer 914ng/ml, Ferritin 3141ng/ml, LDH 672U/L). Her last Rituximab infusion was 3 months prior and leflunomide was withheld on admission. SARS-CoV-2 PCR nasopharyngeal swab was positive, and she was recruited to the RECOVERY trial, being randomized to Lopinavir-Ritonavir for 10 days. Her oxygen requirements increased, and a CT pulmonary angiogram excluded pulmonary embolism but revealed ground glass changes and extensive multilobar consolidation. She was eligible for recruitment into RECOVERY-2 (tocilizumab) given the ongoing oxygen requirement and elevated CRP, but she was randomised to usual care. She was commenced on 80mg of IV methylprednisolone, a dose chosen because of its proven effectiveness in Acute Respiratory Distress Syndrome. She clinically improved and was discharged from hospital 20 days after starting Methylprednisolone with a CRP of 17mg/dL. Two months after discharge, the patient had repeat spirometry study which noted FEV1 of 1.4 (57% predicted), VC of 1.5 (52% predicted), DLCO of 2.4 (28% predicted) and kCO of 1.0 (47% predicted). A repeat high-resolution chest CT reported significant improvement of peripheral ground glass changes and consolidation, but she is still fatigued and more breathless than previously. Case report - Discussion The RECOVERY trial concluded that Dexamethasone reduced mortality in intubated patients and in hospitalised patients with COVID-19 with a high oxygen requirement. The results were published after this patient was discharged. A hyperinflammatory response to COVID-19 is seen in a subset of patients, and our own hospital data suggest that this condition affects around 5% of admitted COVID-19 patients, but that extreme hyperferritinaemia above 10,000 is extremely rare. Similar responses (known as Haemophagocytic Lymphohistiocytosis [HLH]) are seen with a variety of viral and bacterial infections, in malignancy and in inflammatory rheumatic diseases (Macrophage Activation Syndrome [MAS]), but typically HLH and MAS patients have ferritin > 10,000. It appears unlikely that true HLH is a significant manifestation of COVID-19 infection, but moderate hyperferritinaemia is not uncommon and the results of this study, taken together with case reports and series from China and Italy suggest that similar treatments to those used in HLH may transform the prognosis for COVID-19 patients in this subset. It is unknown whether the recent Rituximab infusion had a role in reducing the “cytokine storm” and delaying progression to severe COVID-19. However, it may be argued that the remaining T cells in B cell depleted patients are sufficient for viral clearance. The long-term impact of SARS-CoV-2 on pulmonary function is still unclear. Our patient had a major deterioration in her lung function when compared to her baseline. There was severe reduction in gas transfer post COVID-19. However, her repeat high resolution CT chest reported substantial improvement in ground glass changes and consolidation. The long-term prognosis is still uncertain. Initial fears that patients on DMARDs and biological therapies for inflammatory rheumatic disease would be extremely vulnerable to COVID-19 have not been confirmed, but patients with extra-articular manifestations on combinations of DMARDs and biological therapies may be a subset at higher risk. Case report - Key learning points Our Intensivist colleagues, early in the COVID-19 outbreak, were understandably cautious about using heavily immunosuppressive treatments for a life-threatening viral infection. Using a multi-disciplinary approach at a time when knowledge of how to treat this condition was rudimentary, along with informed consent from an intelligent and thoughtful patient, we were able to plot a middle path to suppress hyperinflammation without using massively immunosuppressive doses of steroid, with a successful outcome. This patient illustrates one aspect of the hyper-inflammatory response seen in a subset of the most critically ill patients with COVID-19. At the time of writing, the RECOVERY 2 trial is yet to be published, but the rapid improvement in inflammatory markers including CRP and Ferritin, along with a dramatic improvement in clinical state, suggest that relatively modest doses of parenteral steroid have life-saving potential at far lower cost and greater worldwide availability than biological therapies such as Tocilizumab or Anakinra. Trials of Tocilizumab in RECOVERY2 and of Anakinra coordinated by the Hyperinflammation Histio UK Haemophagocytosis Across Specialty Collaboration (HASC), as well as international randomised controlled trials will be critical in determining the optimal treatment strategy for this subset of critically ill COVID-19 patients. The experience of our patient suggests that one arm of such studies should include a relatively modest dose of parenteral steroid, be that Dexamethasone or Methylprednisolone, particularly given that COVID-19 is affecting countries across the developing, as well as the developed, world.

scholarly journals THU0207 SUSTAINABILITY OF RESPONSE TO UPADACITINIB AS MONOTHERAPY OR IN COMBINATION AMONG PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO CONVENTIONAL SYNTHETIC DMARDS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 327.1-328
Author(s):  
A. Kavanaugh ◽  
M. H. Buch ◽  
B. Combe ◽  
L. Bessette ◽  
I. H. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Inadequate Response ◽  
Research Support ◽  
Two Phase ◽  
First Occurrence ◽  
Activity Measures ◽  
Disease Activity Measures

Background:The primary treatment goal for patients (pts) with rheumatoid arthritis (RA) is a state of sustained clinical remission (REM) or low disease activity (LDA).1,2Objectives:To assess the long-term sustainability of responses to upadacitinib (UPA), a JAK inhibitor, with or without background csDMARD(s) in pts with RA.Methods:Data are from two phase 3 randomized, controlled trials of UPA in RA pts with roughly similar baseline disease characteristics: SELECT-NEXT enrolled pts with an inadequate response (IR) to csDMARD(s) on background stable csDMARD(s) receiving UPA 15 mg or 30 mg once daily or placebo for 12 weeks (wks); SELECT-MONOTHERAPY enrolled methotrexate (MTX)-IR pts receiving UPA 15 mg or 30 mg monotherapy or blinded MTX for 14 wks. After 12/14 wks, pts could enter a blinded long-term extension and receive UPA 15 mg or 30 mg for up to 5 years. This post hoc analysis evaluated clinical REM (CDAI ≤2.8; SDAI ≤3.3), LDA (CDAI≤10; SDAI≤11), and DAS28(CRP) <2.6/≤3.2 at first occurrence before Wk 84; additionally, these measures were evaluated at 3, 6, and 12 months after the first occurrence for the total number of pts randomized to UPA 15 mg. Sustainability of response was evaluated by Kaplan-Meier only for those pts who achieved REM/LDA and was defined as time to the earliest date of losing response at two consecutive visits or discontinuation of study drug. The predictive ability of time to clinical REM/LDA was assessed using Harrell’s concordance (c)-index (for reference, an index ~ 0.5, indicates no ability to predict; an index of 1 or -1 would be a perfect prediction). The last follow up dates were 22 March, 2018 (SELECT-NEXT) and 25 May, 2019 (SELECT-MONOTHERAPY), when all pts had reached the Wk 84 visit.Results:Through Wk 84, the percent of treated pts achieving CDAI REM/LDA was 43%/79% for those receiving UPA 15 mg with background csDMARD(s) (SELECT-NEXT) and 37%/76% for those receiving UPA 15 mg without background csDMARD(s) (SELECT-MONOTHERAPY). 35%/25% of pts randomized to UPA 15 mg with background csDMARD(s) and 27%/23% of pts randomized to UPA 15 mg without background csDMARD(s) achieved sustained CDAI REM through 6/12 months after the first occurrence. 64%/56% of pts randomized to UPA 15 mg with background csDMARD(s) and 61%/56% of pts randomized to UPA 15 mg without background csDMARD(s) achieved sustained CDAI LDA through 6/12 months after the first occurrence (Figure 1). Time to initial clinical REM/LDA did not appear to be associated with sustained disease control. The c-indices (95%CI) for CDAI REM in the UPA 15 mg with background csDMARD(s) and UPA 15 mg without background csDMARD(s) groups were 0.541 (0.47, 0.62) and 0.568 (0.49, 0.65) and that of LDA were 0.521 (0.46, 0.58) and 0.498 (0.43, 0.56), respectively. Through last follow-up visit, 55% of pts receiving UPA 15 mg with background csDMARD(s) and 62% of pts receiving UPA 15 mg without background csDMARD(s) remained in CDAI REM while 72% and 70% of pts remained in CDAI LDA, respectively (Figure 2). Similar results were observed across other disease activity measures (SDAI REM/LDA and DAS28(CRP) <2.6/≤3.2).Conclusion:More than a quarter and more than a half of pts with RA and prior IR to csDMARD(s) receiving UPA with or without background csDMARD therapy achieved sustained clinical REM and LDA, respectively, across disease activity measures. Sustainability of responses appeared comparable among pts receiving UPA with or without background csDMARDs through up to 84 wks.References:[1]EULAR: Smolen JS, et al. Ann Rheum Dis 2017;76:960–977.[2]ACR: Singh et al. Arthritis & Rheumatology Vol. 68, No. 1, January 2016, pp 1–26.Disclosure of Interests: :Arthur Kavanaugh Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB – grant/research support, Maya H Buch Grant/research support from: Pfizer, Roche, and UCB, Consultant of: Pfizer; AbbVie; Eli Lilly; Gilead Sciences, Inc.; Merck-Serono; Sandoz; and Sanofi, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Yanna Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jessica Suboticki Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB

scholarly journals Cost-Effectiveness of Pembrolizumab Plus Chemotherapy Versus Pembrolizumab Monotherapy in Metastatic Non-Squamous and Squamous NSCLC Patients With PD-L1 Expression ≥ 50%

2022 ◽  
Vol 12 ◽  
Author(s):  
Qiao Liu ◽  
Zhen Zhou ◽  
Xia Luo ◽  
Lidan Yi ◽  
Liubao Peng ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Life Expectancy ◽  
Cost Effective ◽  
Base Case ◽  
First Line ◽  
Term Survival ◽  
First Line Therapy ◽  
Line Therapy ◽  
Nsclc Patients

Objective To compare the cost-effectiveness of the combination of pembrolizumab and chemotherapy (Pembro+Chemo) versus pembrolizumab monotherapy (Pembro) as the first-line treatment for metastatic non-squamous and squamous non-small-cell lung cancer (NSCLC) with PD-L1expression ≥50%, respectively, from a US health care perspective.Material and Methods A comprehensive Makrov model were designed to compare the health costs and outcomes associated with first-line Pembro+Chemo and first-line Pembro over a 20-years time horizon. Health states consisted of three main states: progression-free survival (PFS), progressive disease (PD) and death, among which the PFS health state was divided into two substates: PFS while receiving first-line therapy and PFS with discontinued first-line therapy. Two scenario analyses were performed to explore satisfactory long-term survival modeling.Results In base case analysis, for non-squamous NSCLC patients, Pembro+Chemo was associated with a significantly longer life expectancy [3.24 vs 2.16 quality-adjusted life-years (QALYs)] and a substantially greater healthcare cost ($341,237 vs $159,055) compared with Pembro, resulting in an ICER of $169,335/QALY; for squamous NSCLC patients, Pembro+Chemo was associated with a slightly extended life expectancy of 0.22 QALYs and a marginal incremental cost of $3,449 compared with Pembro, resulting in an ICER of $15,613/QALY. Our results were particularly sensitive to parameters that determine QALYs. The first scenario analysis yielded lower ICERs than our base case results. The second scenario analysis founded Pembro+Chemo was dominated by Pembro.Conclusion For metastatic non-squamous NSCLC patients with PD-L1 expression ≥50%, first-line Pembro+Chemo was not cost-effective when compared with first-line Pembro. In contrast, for the squamous NSCLC patient population, our results supported the first-line Pembro+Chemo as a cost-effective treatment. Although there are multiple approaches that are used for extrapolating long-term survival, the optimal method has yet to be determined.

scholarly journals Cost-Effectiveness Analysis of the Daily HIV Pre-Exposure Prophylaxis in Men who Have Sex with Men in Barcelona

2021 ◽  
Author(s):  
Francesc López Seguí ◽  
Unai Oyon Lerga ◽  
Laura Laguna Marmol ◽  
Pep Coll ◽  
Angels Andreu ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Saving ◽  
Time Horizon ◽  
Cost Savings ◽  
Health Indicators ◽  
Hiv Infections ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Oral Prep

Introduction: Pre-Exposure Prophylaxis (PrEP) for HIV prevention has been implemented in several countries. Previous literature has shown that its cost-effectiveness (and, under some specifications, cost-saving character) is dependent on the reduction in price due to generics, the time-horizon and its effectiveness. The intervention has never been studied in Catalonia, a territory with extensive implementation. Methods: Economic evaluation of the implementation of HIV pre-exposition prophylaxis using administrative data from Men who have Sex with Men (MSM) who receive the treatment (at the generic price). A deterministic compartmental model and a social perspective with a micro-costing approach over the time horizon 2022-2062 are used. A baseline 86% effectiveness of PrEP is assumed. Results: Daily oral PrEP is found to be cost-saving: discounted savings in costs are attained after 16 years, and after 40 years they reach 81 million euros. In terms of health indicators, 10,322 additional discounted QALYs are generated by the intervention. Results are sensitive to sexual behavioral patterns among MSM, the price of PrEP (reduced if offered on-demand), its effectiveness and the discount rate. Conclusions: The use and promotion of PrEP in Catalonia is predicted to result in substantial health and monetary benefits because of reductions in HIV infections. Short-term investments in the promotion of PrEP will result in important cost-savings in the long term.

Cost-utility and cost-effectiveness analyses of a long-term, high-intensity exercise program compared with conventional physical therapy in patients with rheumatoid arthritis

2005 ◽  
Vol 53 (1) ◽  
pp. 39-47 ◽  
Author(s):  
Wilbert B. van den Hout ◽  
Zuzana de Jong ◽  
Marten Munneke ◽  
Johanna M. W. Hazes ◽  
Ferdinand C. Breedveld ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
Physical Therapy ◽  
High Intensity ◽  
Exercise Program ◽  
Cost Utility ◽  
High Intensity Exercise

Long-term Survival of Subcutaneous Anti-tumor Necrosis Factor Biological Drugs Administered Between 2008 and 2012 in a Cohort of Rheumatoid Arthritis Patients

2019 ◽  
Vol 15 (1) ◽  
pp. 54-57
Author(s):  
Noelia Alvarez Rivas ◽  
Tomas R. Vazquez Rodriguez ◽  
Jose A. Miranda Filloy ◽  
Carlos Garcia-Porrua ◽  
Amalia Sanchez-Andrade Fernández
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Biological Drugs ◽  
Term Survival ◽  
Long Term Survival ◽  
Necrosis Factor

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

2019 ◽  
Vol 6 (1) ◽  
pp. e000302 ◽  
Author(s):  
Christoph Lohan ◽  
Alex Diamantopoulos ◽  
Corinne LeReun ◽  
Emily Wright ◽  
Natalie Bohm ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cost Effectiveness ◽  
Conventional Therapy ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Inadequate Response ◽  
Active Ulcerative Colitis ◽  
Biological Therapies ◽  
Infection Rates ◽  
Serious Infection

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.

Sign in / Sign up

Export Citation Format

Share Document