Browsing by Author "Gossec, Laure"
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- Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritisPublication . Kerschbaumer, Andreas; Smolen, Josef S; Ferreira, Ricardo J O; Bertheussen, Heidi; Baraliakos, Xenofon; Aletaha, Daniel; McGoagle, Dennis G; van der Heijde, Désirée; McInnes, Iain B; Esbensen, Bente Appel; Winthrop, Kevin L; Boehncke, Wolf-Henning; Schoones, Jan W; Gossec, LaureObjectives: To obtain an overview of recent evidence on efficacy and safety of pharmacological treatments in psoriatic arthritis (PsA). Methods: This systematic literature research (SLR) investigated the efficacy and safety of conventional synthetic (cs), biological (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in patients with PsA. A systematic database search using Medline, EMBASE, Cochrane CENTRAL was conducted to identify relevant articles published since the previous update in 2019 until 28 December 2022. Efficacy was assessed in trials while for safety observational data were also considered. Adverse events of special interest were infections (including herpes zoster, influenza and tuberculosis), malignancies, major adverse cardiovascular events, venous thromboembolisms, liver disease, laboratory changes and psychiatric adverse events. No meta-analyses were performed. Results: For efficacy, of 3946 articles screened, 38 articles (30 trials) were analysed. The compounds investigated included csDMARDs (leflunomide, methotrexate), bDMARDs inhibiting IL17 (bimekizumab, brodalumab, ixekizumab, izokibep, secukinumab,), IL-23 (guselkumab, risankizumab, tildrakizumab), IL-12/23 (ustekinumab) as well as TNF (adalimumab, certolizumab-pegol, etanercept, infliximab, golimumab) and Janus Kinase inhibitors (JAKi) (brepocitinib, deucravacitinib, tofacitinib, upadacitinib). The compounds investigated were efficacious in improving signs and symptoms of PsA, improving physical functioning and quality of life. For safety, 2055 abstracts were screened, and 24 articles analysed: 15 observational studies and 9 long-term follow-ups of trials, assessing glucocorticoids, TNFi, IL-17i, JAKi, IL-12/23i and PDE4i (apremilast). Safety indicators were generally coherent with the previous SLR in 2019. Conclusion: The results of this SLR informed the task force responsible for the 2023 update of the European Alliance of Associations for Rheumatology recommendations for pharmacological management of PsA.
- EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 updatePublication . Gossec, Laure; Kerschbaumer, Andreas; Ferreira, Ricardo J.O.; Aletha, Daniel; Baraliakos, Xenofon; Bertheussen, Heidi; Boehncke, Wolf-Henning; Esbensen, Bente Appel; McInnes, Iain B; McGonagle, Dennis; Winthrop, Kevin L; Balanescu, Andra; Balint, Peter V; Burmester, Gerd R; Cañete, Juan D; Claudepierre, Pascal; Eder, Lihi; Hetland, Merete Lund; Lagnocco, Annamaria; Kristensen, Lars Erik; Lories, Rik; Queiro, Rubén; Mauro, Daniele; Marzo-Ortega, Helena; Mease, Philip J; Nash, Peter; Wagenaar, Wendy; Savage, Laura; Schett, Georg; Shoop-Worrall, Stephanie J W; Tanaka, Yoshiya; Van den Bosch, Filip E; van der Helm-van Mil, Annette; Zabotti, Alen; van der Heijde, Désirée; Smolen, Josef SObjective: New modes of action and more data on the efficacy and safety of existing drugs in psoriatic arthritis (PsA) required an update of the EULAR 2019 recommendations for the pharmacological treatment of PsA. Methods: Following EULAR standardised operating procedures, the process included a systematic literature review and a consensus meeting of 36 international experts in April 2023. Levels of evidence and grades of recommendations were determined. Results: The updated recommendations comprise 7 overarching principles and 11 recommendations, and provide a treatment strategy for pharmacological therapies. Non-steroidal anti-inflammatory drugs should be used in monotherapy only for mild PsA and in the short term; oral glucocorticoids are not recommended. In patients with peripheral arthritis, rapid initiation of conventional synthetic disease-modifying antirheumatic drugs is recommended and methotrexate preferred. If the treatment target is not achieved with this strategy, a biological disease-modifying antirheumatic drug (bDMARD) should be initiated, without preference among modes of action. Relevant skin psoriasis should orient towards bDMARDs targeting interleukin (IL)-23p40, IL-23p19, IL-17A and IL-17A/F inhibitors. In case of predominant axial or entheseal disease, an algorithm is also proposed. Use of Janus kinase inhibitors is proposed primarily after bDMARD failure, taking relevant risk factors into account, or in case bDMARDs are not an appropriate choice. Inflammatory bowel disease and uveitis, if present, should influence drug choices, with monoclonal tumour necrosis factor inhibitors proposed. Drug switches and tapering in sustained remission are also addressed. Conclusion: These updated recommendations integrate all currently available drugs in a practical and progressive approach, which will be helpful in the pharmacological management of PsA.
- Remission definitions guiding immunosuppressive therapy in rheumatoid arthritis: which is best fitted for the purpose?Publication . Duarte, Cátia; Ferreira, Ricardo J. O.; Welsing, Paco M.; Jacobs, Johannes W. G.; Gossec, Laure; Machado, Pedro M.; van der Heijde, Désirée; Silva, José António Pereira daObjective: To assess which definition of remission best predicts good radiographic outcome (GRO) and good functional outcome (GFO) in rheumatoid arthritis, focusing the updated American College of Rheumatology/European Alliance of Associations for Rheumatology criteria. Material and methods: Meta-analyses of individual patient data (IPD) from randomised controlled trials (RCTs). Six definitions of remission were considered: (1) Boolean with Patient Global Assessment (PGA)≤1 (Boolean); (2) Simplified Disease Activity Index (SDAI)≤3.3; (3) Clinical Disease Activity Index (CDAI)≤2.8; (4) Boolean with PGA≤2 (Updated-Boolean); (5) Boolean with Physician Global Assessment (PhGA≤1) replacing PGA (Boolean-PhGA) and (6) Boolean excluding PGA (3VBoolean). GRO was defined as a worsening ≤0.5 units in radiographic score and GFO as a no worsening in Health Assessment Questionnaire (HAQ), that is, ∆HAQ-DI≤0.0 units. Relationships between each remission definition at 6 and/or 12 months and GRO and GFO during the second year were analysed. Pooled probabilities for each outcome for each definition and their predictive accuracy were estimated. Results: IPD from eight RCTs (n=4423) were analysed. Boolean, SDAI, CDAI, Updated-Boolean, Boolean-PhGA and 3VBoolean were achieved by 24%, 27%, 28%, 32%, 33% and 43% of all patients, respectively. GRO among patients achieving remission ranged from 82.4% (3VBoolean) to 83.9% (SDAI). 3VBoolean showed the highest predictive accuracy for GRO: 51.1% versus 38.8% (Boolean) and 44.1% (Updated-Boolean). The relative risk of GFO ranged from 1.16 (Boolean) to 1.05 (3VBoolean). However, the proportion of GFO correctly predicted was highest for the 3VBoolean (50.3%) and lowest for the Boolean (43.8%). Conclusion: 3VBoolean definition provided the most accurate prediction of GRO and GFO, avoiding the risk of overtreatment in a substantial proportion of patients without increment in radiographic damage progression, supporting the proposal that 3VBoolean remission is preferable to guide immunosuppressive treatment. The patient's perspective, which must remain central, is best served by an additional patient-oriented target: a dual-target approach.
- Remission versus low disease activity as treatment targets in rheumatoid arthritis: how to strike the right balance between too strict and too lenient targets? A meta-epidemiological study of individual patient dataPublication . Duarte, Cátia; Jacobs, Johannes W.G.; Ferreira, Ricardo J.O.; Welsing, Paco M.J.; Gossec, Laure; Machado, Pedro M.; van der Heijde, Désirée; Silva, José António Pereira daObjectives: To evaluate the impact of using Simplified Disease Activity Index (SDAI)-LDA (low disease activity) versus different definitions of remission as a treatment target in established rheumatoid arthritis. Methods: A meta-epidemiological study of individual patient data from eight randomised controlled trials was performed. Four definitions of the target were considered at 6 months: (1) SDAI-LDA: SDAI≤11; (2) SDAI-Remission: SDAI≤3.3; (3) 4V-Remission: Tender and swollen 28-joint counts and C reactive protein (mg/dL) all ≤1 and patient global assessment (PGA)≤2 and (4) 3-variable (3V)-Remission: as 4V, excluding PGA. The mean radiographic change in the modified total Sharp-van der Heijde score (mTSS) and the Good Radiographic Outcome rates (defined as a change of ≤0.5 units mTSS) over 2 years were compared among target definitions. Radiographic progression and the distribution of the individual criteria of the Boolean definition in the only LDA subgroup (3.32, reflecting relevant disease impact. Conclusion: SDAI-LDA is associated with more structural damage over 2 years than any of the definitions of remission. It also allows substantial disease impact to go unchecked and uncontrolled. Physicians should strive for remission whenever possible and safe while also taking into account the different individual disease activity parameters included in the adopted definition.