scholarly journals Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001117 ◽  
Author(s):  
Adeline Ruyssen-Witrand ◽  
Richard Perry ◽  
Clare Watkins ◽  
George Braileanu ◽  
Gayathri Kumar ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Clinical Efficacy ◽  
Meta Analysis ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Comparative Efficacy ◽  
End Points ◽  
American College Of Rheumatology ◽  
Synthetic Dmards ◽  
Evidence Based Decision Making

BackgroundBiologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs are used in patients with psoriatic arthritis (PsA), but few studies directly compare their clinical efficacy. In such situations, network meta-analysis (NMA) can inform evidence-based decision-making.ObjectiveTo evaluate the comparative efficacy and safety of approved bDMARDs in patients with PsA.MethodsBayesian NMA was conducted to compare the clinical efficacy of bDMARDs at weeks 12‒16 in bDMARD-naïve patients with PsA in terms of American College of Rheumatology (ACR) criteria, Psoriatic Arthritis Response Criteria (PsARC) and Psoriasis Area and Severity Index (PASI). Safety end points were evaluated in the overall mixed population of bDMARD-naive and bDMARD-experienced patients.ResultsFor ACR, all treatments except abatacept were statistically superior to placebo. Infliximab was most effective, followed by golimumab and etanercept, which were statistically superior to most other treatments. Ixekizumab 80 mg every 2 weeks (Q2W) was statistically superior to abatacept subcutaneous, apremilast and both regimens of ustekinumab; similar findings were observed for ixekizumab 80 mg Q4W. For PsARC response, ixekizumab did not significantly differ from other therapies, except for golimumab, infliximab and etanercept, which were superior to most other agents including ixekizumab. For PASI response, infliximab was numerically most effective, but was not statistically superior to ixekizumab, which was the next best performing agent. Analysis of safety end points identified few differences between treatments.ConclusionOur NMA confirms the efficacy and acceptable safety profile of bDMARDs in patients with active PsA. There were generally few statistically significant differences between most treatments.

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.

scholarly journals Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study

2021 ◽  
pp. annrheumdis-2020-219014
Author(s):  
Philip J Mease ◽  
Saima Chohan ◽  
Ferran J Garcia Fructuoso ◽  
Michael E Luggen ◽  
Proton Rahman ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
Double Blind Placebo ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Minimal Disease

ObjectivesTo evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).MethodsIn this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs).Results391/500 patients screened were randomised and treated. At W24, 71.4%–79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). Patients receiving tildrakizumab versus placebo generally achieved higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein <3.2, minimal disease activity and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52. Improvement in dactylitis and enthesitis was not observed; results were mixed for other outcomes. Responses in patients switched to tildrakizumab 200 mg at W24 were consistent with treatment from baseline. TEAEs and serious TEAEs occurred in 64.5% and 3.3%, respectively, of all patients through W52 and were comparable among treatment arms.ConclusionsTildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692.

scholarly journals Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52

2020 ◽  
Vol 79 (10) ◽  
pp. 1310-1319 ◽  
Author(s):  
Josef S Smolen ◽  
Philip Mease ◽  
Hasan Tahir ◽  
Hendrik Schulze-Koops ◽  
Inmaculada de la Torre ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Severity Index ◽  
Treat To Target ◽  
Efficacy And Safety ◽  
Life Outcomes ◽  
Open Label ◽  
American College Of Rheumatology ◽  
Parallel Group ◽  
Registration Number ◽  
Disease Modifying

ObjectivesSPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.MethodsSPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.ResultsA significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.ConclusionsIXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use.Trial registration numberNCT03151551.

scholarly journals Comparison of clinical efficacy and safety between dexmedetomidine and propofol among patients undergoing gastrointestinal endoscopy: a meta-analysis

2021 ◽  
Vol 49 (7) ◽  
pp. 030006052110327
Author(s):  
Weihua Liu ◽  
Wenli Yu ◽  
Hongli Yu ◽  
Mingwei Sheng
Keyword(s):  
Clinical Efficacy ◽  
Lower Risk ◽  
Gastrointestinal Endoscopy ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Similar Efficacy ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Inclusion Criteria ◽  
Weighted Mean

Objective To compare the clinical efficacy and safety of dexmedetomidine and propofol in patients who underwent gastrointestinal endoscopy. Methods Relevant studies comparing dexmedetomidine and propofol among patients who underwent gastrointestinal endoscopy were retrieved from databases such as PubMed, Embase, and Cochrane Library. Results Seven relevant studies (dexmedetomidine group, n = 238; propofol group, n = 239) met the inclusion criteria. There were no significant differences in the induction time (weighted mean difference [WMD] = 3.46, 95% confidence interval [CI] = −0.95–7.88, I2 = 99%) and recovery time (WMD = 2.74, 95% CI = −2.72–8.19, I2 = 98%). Subgroup analysis revealed no significant differences in the risks of hypotension (risk ratio [RR] = 0.56, 95% CI = 0.25–1.22) and nausea and vomiting (RR = 1.00, 95% CI = 0.46–2.22) between the drugs, whereas dexmedetomidine carried a lower risk of hypoxia (RR = 0.26, 95% CI = 0.11–0.63) and higher risk of bradycardia (RR = 3.01, 95% CI = 1.38–6.54). Conclusions Dexmedetomidine had similar efficacy and safety profiles as propofol in patients undergoing gastrointestinal endoscopy.

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