A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis

2011 ◽  
Vol 71 (3) ◽  
pp. 319-326 ◽  
Author(s):  
Zoe Ash ◽  
Cécile Gaujoux-Viala ◽  
Laure Gossec ◽  
Elizabeth MA Hensor ◽  
Oliver FitzGerald ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
Clinical Manifestations ◽  
Good Evidence ◽  
Current Evidence ◽  
Efficacy And Safety ◽  
Biologic Drugs ◽  
Synthetic Dmards

ObjectivesTo review the available evidence for the efficacy and safety of non-steroidal anti-inflammatory drugs (NSAIDs), synthetic and biological drug therapies for the different clinical manifestations of psoriatic arthritis (PsA) in order to provide data for the development of treatment recommendations by the European League Against Rheumatism (EULAR) taskforce.MethodsA systematic literature review (SLR) of available treatments for PsA was performed using the largest electronic databases (MEDLINE, EMBASE and COCHRANE) by two working groups formed within the EULAR taskforce. This comprised a comprehensive sample of rheumatologists, dermatologists, epidemiologists and patients. The available evidence was reviewed for NSAIDs, synthetic disease modifying antirheumatic drugs (DMARDs), local and systemic corticosteroids and biologic drugs. All articles and abstracts published between 1962 and January 2010 were reviewed and considered and a meta-analysis of data on biological therapies was performed.ResultsWhile little data are available on NSAIDs, glucocorticoids and synthetic DMARDs, the available evidence suggests an acceptable efficacy and safety profile of both NSAIDs and synthetic DMARDs (methotrexate, cyclosporine A, sulfasalazine and leflunomide) in PsA. More evidence is available (level 1B) supporting the efficacy of anti-tumour necrosis factor (anti-TNF) agents (adalimumab, etanercept, golimumab and infliximab) in treating the signs and symptoms of PsA as well as reducing radiographic progression. Registry data show no new safety concerns, although the numbers studied to date are relatively small.ConclusionsThis SLR reveals some evidence to support the use of NSAIDs and synthetic DMARDs and good evidence for the efficacy of anti-TNF therapy in PsA.

AB0820 COMPARATIVE EFFICACY OF GUSELKUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM SYSTEMATIC LITERATURE REVIEW AND NETWORK META-ANALYSIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1713-1714
Author(s):  
I. Mcinnes ◽  
P. J. Mease ◽  
K. Eaton ◽  
A. Schubert ◽  
S. Peterson ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Adverse Events ◽  
Systematic Literature Review ◽  
Targeted Therapies ◽  
Meta Analysis ◽  
Tumor Necrosis Factor Inhibitor ◽  
Forest Plot ◽  
Research Support ◽  
Phase 3

Background:The efficacy of the interleukin (IL)-23 subunit p19 inhibitor guselkumab (GUS) for psoriatic arthritis (PsA) has recently been demonstrated in two Phase 3 trials (DISCOVER-1 & -2) but has not been evaluated versus existing targeted therapies for PsA.Objectives:To compare GUS to targeted therapies for PsA through network meta-analysis (NMA).Methods:A systematic literature review was performed to identify PsA randomized controlled trials from 2000 to 2018. Bayesian NMAs were performed to compare treatments on American College of Rheumatology (ACR) 20/50/70 response, Psoriasis Area Severity Index (PASI) 75/90/100 response, Health Assessment Questionnaire Disability Index (HAQ-DI) score, resolution of enthesitis (RoE), resolution of dactylitis (RoD), adverse events (AEs) and serious adverse events (SAEs). Analyses used random effects models that adjusted for placebo response via meta-regression on baseline risk when feasible. Results are summarized by ranking treatments according to median absolute probabilities of response derived from NMAs.Results:Twenty-six Phase 3 studies were included in the quantitative synthesis. Studies were placebo-controlled up to 24 weeks and evaluated 13 targeted therapies for PsA. Absolute probabilities are reported for PASI 90 & ACR 20 responses according toFigure 1,and a forest plot of relative risks versus placebo for AEs is reported according toFigure 2. For ACR 20 response, GUS 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) ranked 5th and 8th out of 20 interventions and were comparable to IL-17A inhibitor (IL-17Ai) and most tumor necrosis factor inhibitor (TNFi) agents. Similar findings were observed for ACR 50 and 70 responses. For PASI 90 response, GUS Q4W and Q8W ranked 1st and 2nd out of 15 interventions and were highly likely to provide a greater benefit than most other agents. Similar findings were observed for PASI 75 and 100 responses. For HAQ-DI score, GUS Q4W and Q8W ranked 6th and 10th out of 20 interventions and were comparable to IL-17Ai and most TNFi agents. For RoE, GUS Q4W and Q8W ranked 8th and 6th out of 13 interventions and were comparable to IL-17Ai and TNFi agents. For RoD, GUS Q4W and Q8W ranked 8th and 9th out of 13 interventions and were comparable to most IL-17Ai and TNFi agents. For AEs, GUS Q4W and Q8W ranked 3rd and 2nd out of 19 interventions and were comparable to IL-17Ai and TNFi agents. Likewise, for SAEs, GUS Q4W and Q8W ranked 4th and 5th out of 20 interventions and were comparable to IL-17Ai and TNFi agents. Analyses that controlled for previous exposure to biologics or assessed outcomes at alternative timepoints were broadly consistent with primary analysis results.Conclusion:NMA results indicate that GUS is comparable to most targeted PsA treatments for improvement in arthritis, soft tissue damage, physical function, and safety outcomes. For PASI outcomes, GUS is highly likely to provide a greater benefit than other targeted PsA treatments.Disclosure of Interests:Iain McInnes Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, and UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Kiefer Eaton Shareholder of: Test Pharma, Consultant of: Janssen, Agata Schubert Employee of: Janssen-Cilag, Steve Peterson Employee of: Janssen Research & Development, LLC, Tim Disher Consultant of: Janssen, Wim Noel Employee of: Janssen Pharmaceuticals NV, Hassan Fareen Employee of: Janssen, Chetan Karyekar Shareholder of: Johnson & Johnson, Consultant of: Janssen, Employee of: Janssen Global Services, LLC. Previously, Novartis, Bristol-Myers Squibb, and Abbott Labs., Suzy Van Sanden Employee of: Janssen, Christopher T. Ritchlin Grant/research support from: UCB Pharma, AbbVie, Amgen, Consultant of: UCB Pharma, Amgen, AbbVie, Lilly, Pfizer, Novartis, Gilead, Janssen, Wolf-Henning Boehncke Grant/research support from: Janssen Research & Development, LLC, Consultant of: Janssen

scholarly journals Remission and low disease activity in psoriatic arthritis publications: a systematic literature review with meta-analysis

Rheumatology ◽  
2020 ◽  
Vol 59 (8) ◽  
pp. 1818-1825 ◽  
Author(s):  
Benjamin Hagège ◽  
Elina Tan ◽  
Martine Gayraud ◽  
Bruno Fautrel ◽  
Laure Gossec ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Disease Activity ◽  
Systematic Literature Review ◽  
Activity Index ◽  
Meta Analysis ◽  
Random Effect ◽  
Disease Activity Index ◽  
Low Disease Activity ◽  
Pooled Prevalence

Abstract Objectives Remission (REM) or low disease activity (LDA) is the treatment target in psoriatic arthritis (PsA). The objective of this study was to assess the reporting and prevalence of REM/LDA in published studies of PsA. Methods This was a systematic literature review of all clinical papers published in PubMed, EMBASE or Cochrane database in English between 2012 and 2019 in the field of PsA. Data were collected regarding reporting of REM/LDA by very low disease activity/minimal disease activity (VLDA/MDA), Disease Activity index for Psoriatic Arthritis (DAPSA), or Disease Activity Score 28 joints (DAS28). The pooled rates of REM and LDA by each definition were calculated by random effect meta-analysis. Results In all, 258 publications (corresponding to 114 651 patients), of which 81 (31%) were randomized controlled trials, were analysed: patients’ mean age was 49.4 ( 4.4) years; with a mean disease duration of 8.5 ( 3.8) years. REM/LDA was reported in 91/258 (35.3%) publications. VLDA/MDA was used in 61/91 (67.0%) studies, DAPSA in 27/91 (29.6%) and DAS28 in 28/91 (30.7%), with 40/91 (43.9%) papers reporting several of these definitions. The pooled prevalence (lower–upper limits) of REM was 13.1% (10.9–15.4), 23.1% (16.8–30.1) and 42.1% (33.9–50.4) using VLDA, DAPSA-REM and DAS28, respectively. For LDA the pooled prevalence was 36.3% (32.3–40.5), 52.8% (41.8–63.6) and 60.4% (52.5–68.0) using MDA, DAPSA-LDA and DAS28, respectively. Conclusion REM/LDA status was reported in only1/3 of recent studies on PsA, with important variations in the frequency of these outcomes according to the definition used: 13.1–42.1% for REM, and 36.3–60.4% for LDA. This highlights the need for consensus.

Efficacy and Safety Of Treatments For Relapsed Or Refractory Mantle Cell Lymphoma (MCL): Results Of a Systematic Literature Review

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5099-5099
Author(s):  
Annete Njue ◽  
Peter C Trask ◽  
Ann Colosia ◽  
Robert Olivares ◽  
Shahnaz Khan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Comparative Studies ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Refractory Disease ◽  
Efficacy And Safety ◽  
Free Survival

Abstract Background MCL accounts for approximately 3%-10% of non-Hodgkin’s lymphoma (NHL) cases. The aggressive course of MCL includes rapid disease progression, with temporary responses to chemotherapy, and a high recurrence rate. However, the clinical course is variable with overall survival ranging from 6 months to more than 10 years. Although the median survival with MCL is 3-4 years, for those with relapsed or refractory disease, survival is much shorter. This systematic literature review (SLR) was designed to exhaustively collect and review information on the clinical efficacy and safety of the different interventions used in the treatment of refractory/relapsed MCL, and if possible to perform a meta-analysis. Methods Electronic databases (PubMed, Cochrane Library, Embase) were systematically searched for studies assessing the efficacy of safety of treatments for relapsed or refractory MCL published from 1997 to August 2, 2012. In addition, conference abstracts, bibliographic reference lists of included articles and recent reviews, and the Clinicaltrials.gov database were searched for phase 2, 3, or 4 studies displaying results, potentially unpublished in peer-reviewed journals. Main efficacy outcomes included objective response rate (ORR), complete response, partial response, duration of response, progression-free survival (PFS), and overall survival (OS). Safety endpoints focused on grade 3/4 toxicities and treatment withdrawals due to toxicity. Studies had to report on relapsed or refractory MCL after at least one standard treatment and patients who were not eligible to receive high-dose chemotherapy or stem cell transplant (autologous or allogeneic). Mixed type NHL studies were required to report MCL outcomes separately for inclusion. Results A total of 3,308 publications were identified in the first pass of a broad SLR on NHL; of these, 67 provided relevant data for MCL representing 59 unique studies. Of the 59 studies, 6 were comparative (including 5 RCTs) and 53 were noncomparative single-arm studies; 35 evaluated single-agent regimens, and 24 evaluated combination therapies. A total of 40 different treatments were evaluated in the identified studies. Overall survival and PFS were infrequently reported. Criteria for relapsed or refractory were often not defined, with only 7 studies providing varied definitions. The ORR of active treatments in the few comparative studies ranged from 6%-83%, with most estimates between 45% and 60%. Progression-free survival was approximately 5-7 months with the exception of bortezomib + CHOP in which a 16-month PFS was noted; median OS for these studies ranged from 11-16 months, with 36 months for the aforementioned exception. In the single-arm studies, ORR ranged from 12%-100%, with most estimates from 30%-60%. Progression-free survival was approximately 5-12 months, except for bendamustine alone or in combination (∼21 months) and bortezomib in combination (∼18 months, but with large variability). Overall survival ranged from 12-24 months, with two notable exceptions: bortezomib combination (∼38 months) and temsirolimus in combination with rituximab (∼30 months). Some increase in PFS and OS was observed over the study period. The main safety concerns were related to thrombocytopenia (11-66%), neutropenia (15-100%), anemia (4-34%), and neuropathy (9-13%). Although patients’ MIPI category was collected, outcomes were not reported by this variable. Conclusions The results of this SLR confirm that survival is still low among treatments for relapsed or refractory MCL making this a continued area of unmet need. The small number of randomized trials makes it difficult to identify a standard of care. The lack of common treatments among the randomized controlled trials for MCL and the variability in the populations studied did not allow for a valid meta-analysis. Small sample size, infrequent reporting of OS/PFS, limited information on prior treatments/responses, and patient characteristics also make comparison of results difficult. Comparative studies demonstrating relative survival advantages of various therapies in relapsed or refractory MCL are needed, as is more information on the relation between MIPI scores and outcomes. In the absence of such evidence, management of relapsed or refractory disease should be based on individual patient characteristics and concerns regarding tolerability. Disclosures: Njue: RTI Health Solutions: Employment. Trask:Sanofi: Employment. Colosia:RTI Health Solutions: Employment. Olivares:Sanofi: Employment. Khan:RTI Health Solutions: Employment. Abbe:Sanofi: Employment. Police: RTI Health Solutions: Employment. Wang:RTI Health Solutions: Employment. Sherrill:RTI Health Solutions: Employment. Kaye:RTI Health Solutions: Employment. Awan:Lymphoma Research Foundation (Career Development Award): Research Funding.

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