Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease: A Meta‐Epidemiologic Study

Ballegaard, Christine; Jørgensen, Tanja Schjødt; Skougaard, Marie; Strand, Vibeke; Mease, Philip J.; Kristensen, Lars Erik; Dreyer, Lene; Gottlieb, Alice B.; Wit, Maarten de; Christensen, Robin; Tarp, Simon

doi:10.1002/acr.23455

Cited by 5 publications

(5 citation statements)

References 36 publications

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“… 47 As such, the odds of achieving ACR20 response were lower in trials in which a minimum disease duration of 6 months was required, compared with trials in which disease duration was not in the inclusion criteria. 47 …”

Section: Discussionmentioning

confidence: 98%

“…Results of an exploratory meta-epidemiologic study suggested that certain eligibility criteria have an impact on response to targeted therapies. 47 Prior therapy, disease duration, rheumatoid factor, and use of Classification Criteria for Psoriatic Arthritis criteria for study entry were identified as important contextual factors that may influence the odds of achieving an ACR20 response in PsA trials. 47 As such, the odds of achieving ACR20 response were lower in trials in which a minimum disease duration of 6 months was required, compared with trials in which disease duration was not in the inclusion criteria.…”

Section: Discussionmentioning

confidence: 99%

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Network Meta-Analysis of Tofacitinib, Biologic Disease-Modifying Antirheumatic Drugs, and Apremilast for the Treatment of Psoriatic Arthritis

Gladman

Orbai

Gómez-Reino

et al. 2020

Current Therapeutic Research

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Background Tofacitinib and other new treatments approved for use in psoriatic arthritis have only recently been included in psoriatic arthritis treatment guidelines, and studies evaluating the relative efficacy of available therapies are important to inform treatment decisions by healthcare professionals. Objective To perform a network meta-analysis to evaluate the efficacy and safety profiles of tofacitinib, biologic disease-modifying antirheumatic drugs (bDMARDs), and apremilast in patients with psoriatic arthritis naïve to tumor necrosis factor inhibitor therapy (TNFi-naïve) or with an inadequate response (TNFi-IR). Methods A systematic literature review used searches of MEDLINE, Embase, and The Cochrane Library on October 9, 2017. Randomized controlled trials including adult patients with psoriatic arthritis receiving treatment administered as monotherapy or with conventional synthetic DMARDs were selected. Efficacy outcomes included American College of Rheumatology 20 response, change from baseline in Health Assessment Questionnaire-Disability Index, ≥75% improvement in Psoriasis Area and Severity Index, and change from baseline in Dactylitis Severity Score and Leeds Enthesitis Index. Treatment effects were evaluated during placebo-controlled phases, using a binomial logit model for binary outcomes and a normal identify link model for other outcomes. Discontinuations due to adverse events and serious infection events were assessed as safety outcomes. Results The network meta-analysis included 24 published randomized controlled trials, of which 13 enrolled TNFi-naïve patients only, 3 enrolled TNFi-IR patients only, and 8 enrolled both TNFi-naïve and TNFi-IR patients. Placebo-controlled treatment durations ranged from 12 to 24 weeks. Indirect comparisons showed tofacitinib 5 and 10 mg BID to have similar efficacy compared with most bDMARDs and apremilast in improving joint symptoms (based on American College of Rheumatology 20 response), and with some bDMARDs in improving skin symptoms (based on Psoriasis Area and Severity Index) (tofacitinib 10 mg BID only in TNFi-IR) in patients with psoriatic arthritis who were TNFi-naïve or TNFi-IR. Results also showed that, compared with placebo, the improvement in physical functioning (based on Health Assessment Questionnaire-Disability Index) with tofacitinib 5 and 10 mg BID was similar to that observed with most bDMARDs and apremilast in TNFi-naïve patients, and similar to that observed with all bDMARDs with available data in the TNFi-IR population. Improvements in Dactylitis Severity Score and Leeds Enthesitis Index scores were comparable between treatments. Tofacitinib 5 and 10 mg BID were median-ranked 8 and 15, respectively, for discontinuation due to any adverse events, and 5 and 16, respectively, for a serious infection event out of a total of 20 treatments in the network (lower numbers are more favorable). Conclusions Tofacitinib p...

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Network Meta-Analysis of Tofacitinib, Biologic Disease-Modifying Antirheumatic Drugs, and Apremilast for the Treatment of Psoriatic Arthritis

Gladman

Orbai

Gómez-Reino

et al. 2020

Current Therapeutic Research

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“…The term contextual factor is used in different settings without an agreed-upon definition. Contextual factors may be related to prognostic and/or predictive factors 1,2,3 , and may explain heterogeneity in treatment effects. In 2012, the concept of contextual factors was introduced for the development of core outcome sets (COS) within rheumatology.…”

mentioning

confidence: 99%

Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative

Nielsen¹,

Tugwell²,

Wit³

et al. 2019

J Rheumatol

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Objective.The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT.Methods.During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors.Results.A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important.Conclusion.The identified important contextual factor domains may be considered a provisional list pending further research.

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“…• Inclusion/exclusion criteria: study participants should have similar trial eligibility, such as the same disease and indications for treatment, where they could be randomized to any of the trials in the network [1,4,50]. At the same time, exclusion criteria for comorbidities such as concurrent malignancies and infections should be comparable between studies [31,51,52]. • Clinical trial design and follow-up: clinical trial designs should be comparable [4], with similar treatment durations [3], methods for identifying and measuring treatment outcomes [9] and length of follow-up periods [9].…”

Section: Development Of the Centralized Transitivity Criteriamentioning

confidence: 99%

“…Additionally, Christensen et al [21] potentially detected a modification of the treatment effect based on the disease duration but were unable to demonstrate its independent relative effects from prior DMARD use. Additional PsA, RA and NMA quality guidelines discuss and encourage testing for potential sources of effect modification [5] such as patient comorbidities [51,52] and gender (Consensus Working Party 2013); however, none of the extracted RCTs tested against these potential biases. Furthermore, two full publication NMAs that included apremilast cited variations in study populations and a lack of covariate adjustment in the meta-regressions as limitations; however, potential biases related to transitivity were not measured [18,20].…”

Section: Effect Modificationmentioning

confidence: 99%

A criterion-based approach to systematic and transparent comparative effectiveness: a case study in psoriatic arthritis

Tremblay¹,

Westley²,

Forsythe³

et al. 2019

J. Comp. Eff. Res.

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Aim: Indirect treatment comparisons are used when no direct comparison is available. Comparison networks should satisfy the transitivity assumption, that is, equal likelihood of treatment assignment for a given patient based on comparability of studies. Materials & methods: Seven criteria were evaluated across 18 randomized controlled trials in psoriatic arthritis: inclusion/exclusion criteria, clinical trial design and follow-up, patient-level baseline characteristics, disease severity, prior therapies, concomitant and extended-trial treatment and placebo response differences. Results: Across studies, placebo was a common comparator, and key efficacy end points were reported. Collectively, several potential sources of insufficient transitivity were identified, most often related to trial design and population differences. Conclusion: Potential challenges in satisfying transitivity occur frequently and should be evaluated thoroughly.

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Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease: A Meta‐Epidemiologic Study

Cited by 5 publications

References 36 publications

Network Meta-Analysis of Tofacitinib, Biologic Disease-Modifying Antirheumatic Drugs, and Apremilast for the Treatment of Psoriatic Arthritis

Network Meta-Analysis of Tofacitinib, Biologic Disease-Modifying Antirheumatic Drugs, and Apremilast for the Treatment of Psoriatic Arthritis

Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative

A criterion-based approach to systematic and transparent comparative effectiveness: a case study in psoriatic arthritis

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