Biological Therapy for Psoriatic Arthritis in Clinical Practice: Outcomes Up to 2 Years

2010 ◽  
Vol 37 (11) ◽  
pp. 2362-2368 ◽  
Author(s):  
LIISA M. VIRKKI ◽  
BINDU C. SUMATHIKUTTY ◽  
MERJA AARNIO ◽  
HEIKKI VALLEALA ◽  
RIITTA HEIKKILÄ ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Health Assessment ◽  
Routine Care ◽  
Biological Drugs ◽  
Acr20 Response ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Factor Α ◽  
Assessment Questionnaire ◽  
Necrosis Factor

Objective.To evaluate the performance of biological drugs in psoriatic arthritis (PsA) in a routine care setting, using the Finnish national register of biological treatment (ROB-FIN).Methods.Patients with PsA who started therapy with infliximab or etanercept between June 2000 and February 2006 (n = 127) were followed for up to 24 months. Response was evaluated using American College of Rheumatology response criteria including individual measures.Results.Significantly diminished values for swollen and tender joints, patient’s global and pain assessments, doctor’s global assessment of disease activity, erythrocyte sedimentation rate, C-reactive protein, and Health Assessment Questionnaire score were observed within 3 months after commencement of both infliximab and etanercept. Values remained significantly lower throughout the 24 months of followup. ACR20 response at 3 months was 79% (n = 22/28) for infliximab and 76% (n = 34/45) for etanercept. The first biological drug was discontinued in 16% due to lack of effectiveness and in 6% due to adverse events.Conclusion.Anti-tumor necrosis factor-α therapy, often combined with conventional disease-modifying antirheumatic drugs, appeared to have limited toxicity and persistent effectiveness for up to 2 years in a cohort of Finnish patients with severe peripheral PsA.

Treatment of Dactylitis and Enthesitis in Psoriatic Arthritis with Biologic Agents: A Systematic Review and Metaanalysis

2019 ◽  
Vol 47 (1) ◽  
pp. 59-65 ◽  
Author(s):  
Ahmed Mourad ◽  
Robert Gniadecki
Keyword(s):  
Psoriatic Arthritis ◽  
Health Assessment ◽  
Pooled Analysis ◽  
Biologic Agents ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Tnf Α ◽  
Life Improvement ◽  
Factor Α

Objective.Biologic agents with different mechanisms of action [inhibitors of tumor necrosis factor-α (TNF-α), interleukin (IL)-12/23, and IL-17] showed efficacy in randomized controlled trials (RCT) in the treatment of psoriatic arthritis. We conducted a pooled metaanalysis of these agents for treatment of dactylitis and enthesitis and compared results with the American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire–Disability Index (HAQ-DI) scores.Methods.A systematic literature search was performed and a pooled metaanalysis of RCT with anti-TNF-α (infliximab, golimumab, adalimumab), anti–IL-12/23 (ustekinumab), and anti–IL-17 (secu kinumab, ixekizumab) was conducted using the random-effects model. Bias was assessed using the Cochrane risk-of-bias tool.Results.Eighteen RCT were included in the pooled analysis (n = 6981). Both TNF-α inhibitors and novel biologics (ustekinumab, secukinumab, ixekizumab) demonstrated significant resolution of dactylitis at Week 24 with pooled risk ratios (RR) versus placebo of 2.57 (95% CI 1.36–4.84) and 1.88 (95% CI 1.33–2.65), respectively. For resolution of enthesitis at Week 24, RR for TNF-α inhibitors was 1.93 (95% CI 1.33–2.79) versus 1.95 (95% CI 1.60–2.38) for novel biologics. Both biologic categories showed overlapping ranges of ACR20 responses (TNF-α inhibitors: RR = 2.23, 95% CI 1.60–3.11; pooled IL-12/23 and −17: RR = 2.30, 95% CI 1.94–2.72) and similar quality of life improvement scores with mean HAQ-DI score changes of −0.29 (95% CI −0.39 to −0.19) and −0.26 (95% CI −0.31 to −0.22), respectively.Conclusion.The pooled analysis demonstrated that anti–TNF-α agents have the same efficacy as novel agents (ustekinumab, secukinumab, and ixekizumab) in dactylitis and enthesitis.

Association of previous treatment with anti-tumour necrosis factor inhibitors with the effectiveness of secukinumab in the treatment of psoriatic arthritis: systematic review and meta-analysis

Rheumatology ◽  
2020 ◽  
Vol 59 (12) ◽  
pp. 3657-3665
Author(s):  
Yantao Xu ◽  
Yuting Li ◽  
Mengyuan Dong ◽  
Zi’ang Gao ◽  
Xiang Chen ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Meta Analysis ◽  
Previous Treatment ◽  
Cochrane Library ◽  
Acr20 Response ◽  
Naive Group ◽  
American College Of Rheumatology ◽  
History Of ◽  
Effectiveness Data ◽  
Necrosis Factor

Abstract Objectives We sought to systematically investigate the effectiveness of secukinumab in psoriatic arthritis (PsA) patients who previously received TNFs inhibitor (TNFi) treatment and those who were TNFi naïve. Methods Databases (PubMed, EMBase and Cochrane library) and ClinicalTrials.gov were searched from inception to 22 May 2020 for randomized control trails and observational studies of secukinumab, with or without a history of previous anti-TNFi treatment, in PsA. Effectiveness data were extracted and combined using a random-effects meta-analysis. The ACR20 and ACR50 (20% and 50% improvement in American College of Rheumatology response criteria) responses were the endpoints. Results Six randomized controlled trials that reported the effectiveness of secukinumab by previous anti-TNFi treatment were included. Among patients exposed to a prior anti-TNFi treatment (n = 738), 33.7% (249/738) of patients achieved an ACR20 response. In contrast, in the anti-TNFi-naïve group (n = 1754), 49.8% (873/1754) of patients achieved an ACR20 response. Prior treatment with anti-TNFi was significantly associated with a poorer response to secukinumab compared with the anti-TNFi-naïve group with an effect size of 2.09 (95% CI: 1.69, 2.58). Conclusion Some patients benefit from switching from TNFi to secukinumab, but previous anti-TNFi treatment is associated with poorer effectiveness of secukinumab.

scholarly journals Comparison of Etanercept Monotherapy and Combination Therapy with Methotrexate in Psoriatic Arthritis: Results from 2 Clinical Trials

2016 ◽  
Vol 43 (6) ◽  
pp. 1063-1067 ◽  
Author(s):  
Bernard Combe ◽  
Frank Behrens ◽  
Neil McHugh ◽  
Fiona Brock ◽  
Urs Kerkmann ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Combination Therapy ◽  
Health Assessment ◽  
Severity Index ◽  
Joint Disease ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Psa Response ◽  
Questionnaire Disability

Objective.To evaluate the clinical/functional outcomes associated with etanercept (ETN) monotherapy versus combination therapy in psoriatic arthritis (PsA).Methods.Data from patients with PsA who received ETN alone (n = 322) or combined with methotrexate (MTX; n = 152) for 24 weeks in 2 placebo-controlled clinical trials were summarized across studies.Results.Similar proportions of patients in the monotherapy and combination therapy groups achieved the PsA Response Criteria (80% and 83%) and the American College of Rheumatology improvements of 20% (ACR20; both 70%); numerically higher proportions receiving monotherapy achieved ACR50 (55% vs 48%) and ACR70 (35% vs 27%). Little between-group difference was observed in the 28-joint Disease Activity Score with C-reactive protein, the Psoriasis Area and Severity Index, and the Health Assessment Questionnaire–Disability Index improvement.Conclusion.ETN with and without MTX provided similar benefits in active PsA.

scholarly journals Association of Pharmacological Biomarkers with Treatment Response and Longterm Disability in Patients with Psoriatic Arthritis: Results from OUTPASS

2019 ◽  
Vol 47 (8) ◽  
pp. 1204-1208 ◽  
Author(s):  
Meghna Jani ◽  
Hector Chinoy ◽  
Anne Barton
Keyword(s):  
Psoriatic Arthritis ◽  
Treatment Response ◽  
Health Assessment ◽  
Tumor Necrosis Factor Inhibitor ◽  
Drug Level ◽  
Serum Samples ◽  
Drug Levels ◽  
Factor Inhibitor ◽  
Assessment Questionnaire ◽  
Necrosis Factor

Objective.To identify (1) whether tumor necrosis factor inhibitor (TNFi) drug levels/anti-drug antibodies (ADAb) are associated with treatment response and disability in patients with psoriatic arthritis (PsA); and (2) the factors associated with TNFi drug levels.Methods.Patients were recruited from a national multicenter prospective cohort with longitudinal serum samples and 28-joint count Disease Activity Scores (DAS28)/Health Assessment Questionnaire (HAQ) measurement over 12 months.Results.Adalimumab (ADA) drug levels were significantly associated with ΔDAS28 (β 0.055, 95% CI 0.011–0.099; p = 0.014) and inversely with HAQ over 12 months (β −0.022, 95% CI −0.043 to −0.00063). Factors significantly associated with ADA drug levels were ADAb levels and body mass index.Conclusion.Drug level testing in ADA-initiated PsA patients may be useful in determining treatment response/disability over 12 months.

FCGR2A/CD32AandFCGR3A/CD16AVariants and EULAR Response to Tumor Necrosis Factor-α Blockers in Psoriatic Arthritis: A Longitudinal Study with 6 Months of Followup

2012 ◽  
Vol 39 (5) ◽  
pp. 1035-1041 ◽  
Author(s):  
JULIO RAMÍREZ ◽  
JOSÉ LUIS FERNÁNDEZ-SUEIRO ◽  
RAQUEL LÓPEZ-MEJÍAS ◽  
CARLOS MONTILLA ◽  
MAITE ARIAS ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Tumor Necrosis Factor Α ◽  
Eular Response ◽  
Protein Levels ◽  
Reactive Protein ◽  
Tnf Α ◽  
Factor Α ◽  
Necrosis Factor

Objective.The efficacy of antibody-based biological therapies currently used in psoriatic arthritis (PsA) depends not only on their blocking effect on the targeted molecule but also on their binding affinity to genetically defined variants of cell-surface Fc-γ receptors. Our objective was to assess the potential influence of functionally relevantFCGR2A/CD32A(H131R) andFCGR3A/CD16A(V158F) genetic polymorphisms on the EULAR response to tumor necrosis factor-α (TNF-α) blocker therapy in PsA.Methods.In total 103 patients with PsA starting anti-TNF-α therapy were included. The efficacy of therapy was evaluated according to EULAR response criteria at 3 and 6 months.FCGR2A-R131H andFCGR3A-F158V polymorphisms were genotyped. Potential correlations between clinical response and theFCGR2A-R131H andFCGR3A-F158V polymorphisms were evaluated.Results.EULAR response (moderate plus good) was 85.4% at 3 months and 87.4% at 6 months, while good EULAR response was 61.2% and 62.1%, respectively. More patients with high-affinityFCGR2Agenotypes (homozygous or heterozygous combinations) achieved a EULAR response at 6 months compared to patients with the low-affinity genotype (RR; p = 0.034, adjusted comparison error rate < 0.025). This association was due mainly to the group of patients treated with etanercept. No correlation was found for theFCGR3Apolymorphism. Similarly, no effect of C-reactive protein levels was observed.Conclusion.Our data indicate thatFCGR2Apolymorphism may influence the response to TNF-α blockers (namely etanercept) in PsA in a direction opposite to that previously found in patients with rheumatoid arthritis.

Effectiveness and Feasibility Associated with Switching to a Second or Third TNF Inhibitor in Patients with Psoriatic Arthritis: A Cohort Study from Southern Sweden

2015 ◽  
Vol 43 (1) ◽  
pp. 81-87 ◽  
Author(s):  
Lars Erik Kristensen ◽  
Elisabeth Lie ◽  
Lennart T.H. Jacobsson ◽  
Robin Christensen ◽  
Philip J. Mease ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Health Assessment ◽  
Response Rates ◽  
Joint Disease ◽  
Tnf Inhibitor ◽  
Acr20 Response ◽  
Logistic Regression Models ◽  
Drug Survival ◽  
American College Of Rheumatology ◽  
First Time

Objective.Because new modes of action for the treatment of psoriatic arthritis (PsA) are emerging, it is important to understand the use of switching to a second or third antitumor necrosis factor (anti-TNF) agent. This study investigated drug survival and treatment response rates of patients with PsA undergoing second- and third-line anti-TNF therapy.Methods.Patients with PsA were monitored in a prospective, observational study. Patients who switched anti-TNF therapy once (first-time switchers, n = 217) or twice (second-time switchers, n = 57) between January 2003 and March 2012 were studied. American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) good response at 3 and 6 months, as well as drug survival, were reported and further analyzed using the Cox and logistic regression models.Results.Median age for first-time switchers was 47 years and 42% were men. The corresponding values for second-time switchers were 48 years and 40% men. Three-month ACR20 Lund Efficacy Index (LUNDEX) response was achieved by 47% of first-time and 22% of second-time switchers; ACR50 LUNDEX rates were 21% and 14%, ACR70 LUNDEX rates were 12% and 2%, and EULAR good LUNDEX rates were 26% and 10%, respectively. Median drug survival time for patients switching anti-TNF for the first time was 64 months (95% CI 31–97) compared with 14 months (95% CI 5–23) for second-time switchers. Identified baseline predictor of ACR20 response to second-line treatment was the 28-joint Disease Activity Score values at baseline (OR 1.45, 95% CI 1.01–2.10), while higher Health Assessment Questionnaire scores predicted premature drug withdrawal (HR 1.60, 95% CI 1.03–2.48).Conclusion.Response rates of first-time anti-TNF switchers are moderate, while the inferior response rates of second-time switchers suggest other therapeutic options should be considered in this situation.

scholarly journals Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis

2017 ◽  
Vol 76 (9) ◽  
pp. 1550-1558 ◽  
Author(s):  
Philip J Mease ◽  
Alice B Gottlieb ◽  
Désirée van der Heijde ◽  
Oliver FitzGerald ◽  
Alyssa Johnsen ◽  
...  
Keyword(s):  
Health Assessment ◽  
Phase Iii ◽  
Open Label ◽  
Acr20 Response ◽  
Factor Inhibitor ◽  
Phase Iii Study ◽  
Musculoskeletal Manifestations ◽  
Assessment Questionnaire ◽  
Necrosis Factor ◽  
Questionnaire Disability

ObjectivesTo assess the efficacy and safety of abatacept, a selective T-cell costimulation modulator, in a phase III study in psoriatic arthritis (PsA).MethodsThis study randomised patients (1:1) with active PsA (~60% with prior exposure to a tumour necrosis factor inhibitor) to blinded weekly subcutaneous abatacept 125 mg (n=213) or placebo (n=211) for 24 weeks, followed by open-label subcutaneous abatacept. Patients without ≥20% improvement in joint counts at week 16 were switched to open-label abatacept. The primary end point was the proportion of patients with ≥20% improvement in the American College of Rheumatology (ACR20) criteria at week 24.ResultsAbatacept significantly increased ACR20 response versus placebo at week 24 (39.4% vs 22.3%; p<0.001). Although abatacept numerically increased Health Assessment Questionnaire–Disability Index response rates (reduction from baseline ≥0.35) at week 24, this was not statistically significant (31.0% vs 23.7%; p=0.097). The benefits of abatacept were seen in ACR20 responses regardless of tumour necrosis factor inhibitor exposure and in other musculoskeletal manifestations, but significance could not be attributed due to ranking below Health Assessment Questionnaire–Disability Index response in hierarchical testing. However, the benefit on psoriasis lesions was modest. Efficacy was maintained or improved up to week 52. Abatacept was well tolerated with no new safety signals.ConclusionsAbatacept treatment of PsA in this phase III study achieved its primary end point, ACR20 response, showed beneficial trends overall in musculoskeletal manifestations and was well tolerated. There was only a modest impact on psoriasis lesions.Trial registration numberClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb).

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 Experience in using secukinumab in patients with axial psoriatic arthritis

2020 ◽  
Vol 14 (4) ◽  
pp. 150-156
Author(s):  
E. E. Gubar ◽  
Yu. L. Korsakova ◽  
E. Yu. Loginova ◽  
T. V. Korotaeva
Keyword(s):  
Psoriatic Arthritis ◽  
Subjective Assessment ◽  
Axial Skeleton ◽  
Disease Modifying Antirheumatic Drugs ◽  
Biological Drugs ◽  
Skeletal Injury ◽  
Interleukin 17A ◽  
Inflammatory Drugs ◽  
Factor Α ◽  
Necrosis Factor

Axial skeletal injury is observed in 25–70% of patients with psoriatic arthritis (PsA). Spondylitis frequently occurs subclinically, which leads to serious structural and functional disorders over time. An update shows that axial skeleton involvement in PsA is characterized by a more severe clinical course: these patients are observed to have a greater severity of peripheral arthritis, enthesitis, and dactylitis, skin and nail psoriasis, a higher CRP level, and worse functional status. In addition, the disease is more severe according to the patients' subjective assessment, as evidenced by questionnaires. Synthetic disease-modifying antirheumatic drugs used to treat peripheral PsA are not recommended for axial injury. When nonsteroidal anti-inflammatory drugs are ineffective, biological drugs (tumor necrosis factor-α inhibitors or interleukin-17A (IL-17A) inhibitors) should be prescribed immediately to patients with psoriatic spondylitis. The paper describes two clinical cases demonstrating the successful use of the IL-17A inhibitor secukinumab (SEC) in patients with axial PsA (axPsA). Given the positive experience with SEC in real clinical practice, it seems reasonable to prescribe it to patients at earlier stages of axPsA.

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