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French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults.

ABSTRACT: These guidelines were developed by the psoriasis research group of the French Society of Dermatology with the aim of providing updated decision-making algorithms for the systemic treatment of adult patients with moderate-to-severe psoriasis. Our algorithms were generated after rigorous evaluation of existing guidelines on the treatment of psoriasis and of publications concerning new systemic treatments, not yet incorporated into existing guidelines. A total of nine existing guidelines and 53 publications related to new systemic treatments were found to meet our criteria for use in the generation of the algorithms. We have proposed two new algorithms to assess therapeutic responses, both of which incorporate emerging criteria for evaluating treatment goals. Updated therapeutic strategy algorithms, incorporating both established and new systemic therapies, were also generated for the treatment of plaque psoriasis and psoriatic arthritis, together with recommendations for the treatment of particular forms of psoriasis and treatment of patients with comorbidities.

SUBMITTER: Amatore F

PROVIDER: S-EPMC6593704 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults.

Amatore F F Villani A-P AP Tauber M M Viguier M M Guillot B B

Journal of the European Academy of Dermatology and Venereology : JEADV 20190222 3

These guidelines were developed by the psoriasis research group of the French Society of Dermatology with the aim of providing updated decision-making algorithms for the systemic treatment of adult patients with moderate-to-severe psoriasis. Our algorithms were generated after rigorous evaluation of existing guidelines on the treatment of psoriasis and of publications concerning new systemic treatments, not yet incorporated into existing guidelines. A total of nine existing guidelines and 53 pub ...[more]

PMID: 30793796

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Project description:BACKGROUND:The persistence and effectiveness of systemic therapies for moderate-to-severe psoriasis in current clinical practice are poorly characterized. OBJECTIVES:To systematically review observational studies investigating the persistence and effectiveness of acitretin, ciclosporin, fumaric acid esters (FAE) and methotrexate, involving at least 100 adult patients with moderate-to-severe psoriasis, exposed to therapy for ≥ 3 months. METHODS:MEDLINE, Embase, the Cochrane Library and PubMed were searched from 1 January 2007 to 1 November 2017 for observational studies reporting on persistence (therapy duration or the proportion of patients discontinuing therapy during follow-up) or effectiveness [improvements in Psoriasis Area and Severity Index (PASI) or Physician's Global Assessment (PGA)]. This review was registered with PROSPERO, number CRD42018099771. RESULTS:Of 411 identified studies, eight involving 4624 patients with psoriasis were included. Variations in the definitions and analyses of persistence and effectiveness outcomes prevented a meta-analysis from being conducted. One prospective multicentre study reported drug survival probabilities of 23% (ciclosporin), 42% (acitretin) and 50% (methotrexate) at 1 year. Effectiveness outcomes were not reported for either acitretin or ciclosporin. The persistence and effectiveness of FAE and methotrexate were better characterized, but mean discontinuation times ranged from 28 to 50 months for FAE and 7·7 to 22·3 months for methotrexate. At 12 months of follow-up, three studies reported that 76% (FAE), 53% (methotrexate) and 59% (methotrexate) of patients achieved ≥ 75% reduction in PASI, and one reported that 76% of FAE-exposed patients achieved a markedly improved or clear PGA. CONCLUSIONS:The comparative persistence and effectiveness of acitretin, ciclosporin, FAE and methotrexate in real-world clinical practice in the past decade cannot be well described due to the inconsistency of the methods used.

Project description:BackgroundWhen multiple treatments are available, network meta-analysis can synthesize evidence and rank their relative profile in terms of effectiveness and/or safety. We applied this approach to the safety of subcutaneous biologicals used in the treatment of moderate to severe psoriasis.MethodsOur literature search covered the articles published from January 2000 to September 2014 and was restricted to randomized controlled trials. The agents eligible for our analysis were subcutaneous biological drugs used in patients with moderate to severe psoriasis. A network meta-analysis was conducted using the Bayesian model. The analysis was aimed to compare the safety of these treatments based on 95 % credible intervals and to consequently generate a ranking in safety across the treatments. Two safety end-points were considered: any serious adverse events (AE) and any infectious AE. Risk difference was the outcome measure. The analysis estimated 95 % credible intervals for all direct and indirect comparisons as well as the ranking histogram across the treatments which was determined according to model-based probabilistic analysis.ResultsOur literature search selected a total of 13 randomized controlled trials of which three evaluated adalimumab, five ustekinumab (45 and 90 mg), four etanercept (both high-dose and low-dose) and one high-dose etanercept and ustekinumab (45 and 90 mg). For both end-points of any serious AE and any infectious AE, the Bayesian analysis showed no significant difference in all indirect head-to-head comparisons between active agents. For the end-point of any serious AE, the ranking was ustekinumab 45 mg and ustekinumab 90 mg (at the same rank), followed by placebo and by adalimumab and high-dose etanercept (at the same rank). For any infectious AE, the ranking was: low-dose etanercept, placebo, ustekinumab 45 mg and ustekinumab 90 mg, adalimumab and high-dose etanercept.ConclusionOur analysis synthesized the current evidence on the safety of subcutaneous biological treatments for patients with moderate to severe psoriasis and was successful in defining their respective rankings.

Project description:IntroductionThe long-term benefit-risk profiles of licensed and investigational treatments for moderate-to-severe plaque psoriasis have not been fully characterized.MethodsRandomized controlled trials (RCTs) of licensed and investigational treatments for moderate-to-severe plaque psoriasis were identified through a systematic literature review through 2 May 2021. Bayesian network meta-analyses (NMAs) were conducted to compare the efficacy (Psoriasis Area and Severity Index [PASI] 75/90/100 [at least a 75/90/100% reduction in PASI score from baseline] response) and safety outcomes (any adverse event [AE], any serious AE [SAE], and AEs leading to treatment discontinuation) of each treatment evaluated between weeks 48 and 56 after baseline. Surfaces under the cumulative ranking curves (SUCRAs) were calculated to evaluate the relative ranking of treatments. The benefit-risk profiles of treatments were assessed by bidimensional plots of the NMA-estimated efficacy and safety outcomes.ResultsIn the efficacy NMA (N = 14 RCTs), the relative rankings for PASI 75/90/100 responses by weeks 48-56 were the highest for risankizumab (SUCRA: 98.5%) and bimekizumab (83.8% for dosing every 4 weeks [Q4W], 72.7% for dosing Q4W then every 8 weeks). The PASI response rates did not differ significantly between risankizumab and the two bimekizumab regimens. Additionally, risankizumab was associated with significantly higher PASI response rates than brodalumab, guselkumab, ixekizumab, secukinumab, ustekinumab, adalimumab, and etanercept. In the safety NMAs (N = 8 RCTs), risankizumab had the highest relative rankings for all three outcomes (SUCRA: 92.1%, 82.0%, and 91.0% for any AE, any SAE, and AEs leading to treatment discontinuation, respectively). Risankizumab had a significantly lower rate of any AE than bimekizumab, ustekinumab, and secukinumab.ConclusionsRisankizumab was associated with the most favorable long-term benefit-risk profile for the treatment of moderate-to-severe plaque psoriasis. Although ixekizumab and bimekizumab had favorable efficacy profiles, both treatments had lower rankings for safety outcomes.

Project description:Importance:Systemic psoriasis treatments vary in efficacy and cost but also in time until onset of action. Patients with no response to a first induction treatment are typically switched to another, and some patients require several treatments before they see an improvement. Objective:To determine the most cost-effective sequence of induction treatment through a comparative time-effectiveness analysis of different systemic treatment sequences currently licensed in Germany for moderate to severe plaque psoriasis. Design, Setting, and Participants:This time-effectiveness analysis used a decision-analytic model set in the German health care system. The population simulated to receive the treatment sequences consisted of adult men and women with psoriasis vulgaris or plaque type psoriasis eligible for systemic treatment. Systematic reviews were performed to generate model input values. Data were collected from November 1 through December 15, 2017, and analyzed from January through August 2018. Interventions:Five treatment sequences frequently used in Germany, identified through an online expert survey (response rate, 10 of 15 [66.7%]), and 4 theoretical sequences starting with a biological agent. Treatments included methotrexate sodium (MTX), cyclosporine (CSA), fumaric acid esters (FAE), adalimumab (ADA), ixekizumab (IXE), infliximab (INF), and secukinumab (SEC). Main Outcomes and Measures:Two health states were defined: responder (patients achieving a Psoriasis Area Severity Index [PASI] ?75) and nonresponder (PASI <75). Probability values were defined as response rates of PASI-75. Treatment effects were determined by the mean change in Dermatology Life Quality Index (DLQI) score. Time until onset of action was assessed as weeks until 25% of patients reach PASI-75. Individual time-effectiveness ratios were calculated per treatment sequence as time until onset of action (in weeks) per minimally important difference (MID) in DLQI and were subsequently ranked. Results:Treatment sequences starting with a biological agent, including IXE-INF-SEC (1.4 weeks per DLQI-MID), INF-IXE-SEC (2.05 weeks per DLQI-MID), SEC-IXE-ADA (2.1 weeks per DLQI-MID), and ADA-IXE-SEC (2.8 weeks per DLQI-MID) were more time-effective than frequently used treatment sequences, including MTX-SEC-ADA (6.8 weeks per DLQI-MID), MTX-ADA-IXE (7.0 weeks per DLQI-MID), MTX-ADA-SEC (7.2 weeks per DLQI-MID), MTX-FAE-ADA (10.05 weeks per DLQI-MID), and FAE-MTX-CSA (11.5 weeks per DLQI-MID). The results were robust to deterministic sensitivity analyses. Conclusions and Relevance:When allocating monetary resources, policy makers and regulators may want to consider time until patients experience an MID in their quality of life as an additional outcome measure. Trial Registration:PROSPERO Identifier: CRD42017074218.

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French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults.

Publications

French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults.

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