Dataset Information

Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study.

ABSTRACT:

Background

To date, only a few real-world-setting studies evaluated apremilast effectiveness in psoriatic arthritis (PsA). The aims of this retrospective observational study are to report long-term Disease Activity Index for Psoriatic Arthritis (DAPSA) response of apremilast in PsA patients and to analyze the predictors of clinical response.

Methods

All PsA consecutive patients treated with apremilast in fifteen Italian rheumatological referral centers were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline, 6 months, and 12 months were recorded. The Mann-Whitney test and chi-squared tests assessed the differences between independent groups, whereas the Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. Logistic regressions verified if there were factors associated with achievement of DAPSA low disease activity or remission at 6 and 12 months.

Results

DAPSA low disease activity or remission rates at 6 and 12 months were observed, respectively, in 42.7% (n = 125) and 54.9% (n = 161) patients. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio (OR) 0.841, 95% confidence interval (CI) 0.804-0.879; p < 0.01) and at 12 months (OR 0.911, 95% CI 0.883-0.939; p < 0.01).

Conclusions

Almost half of the PsA patients receiving apremilast achieved DAPSA low disease activity or remission at 6 and 12 months. The only factor associated with achievement of low disease activity or remission at both 6 and 12 months was baseline DAPSA.

SUBMITTER: Becciolini A

PROVIDER: S-EPMC9953385 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study.

Becciolini Andrea A Parisi Simone S Del Medico Patrizia P Farina Antonella A Visalli Elisa E Molica Colella Aldo Biagio AB Lumetti Federica F Caccavale Rosalba R Scolieri Palma P Andracco Romina R Girelli Francesco F Bravi Elena E Colina Matteo M Volpe Alessandro A Ianniello Aurora A Ditto Maria Chiara MC Nucera Valeria V Franchina Veronica V Platè Ilaria I Donato Eleonora Di ED Amato Giorgio G Salvarani Carlo C Bernardi Simone S Lucchini Gianluca G De Lucia Francesco F Molica Colella Francesco F Santilli Daniele D Mansueto Natalia N Ferrero Giulio G Marchetta Antonio A Arrigoni Eugenio E Foti Rosario R Sandri Gilda G Bruzzese Vincenzo V Paroli Marino M Fusaro Enrico E Ariani Alarico A

Biomedicines 20230202 2

<h4>Background</h4>To date, only a few real-world-setting studies evaluated apremilast effectiveness in psoriatic arthritis (PsA). The aims of this retrospective observational study are to report long-term Disease Activity Index for Psoriatic Arthritis (DAPSA) response of apremilast in PsA patients and to analyze the predictors of clinical response.<h4>Methods</h4>All PsA consecutive patients treated with apremilast in fifteen Italian rheumatological referral centers were enrolled. Anamnestic da ...[more]

PMID: 36830969

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Project description:IntroductionPsoriatic arthritis (PsA) is a spondyloarthritis that occurs in up to 30% of psoriasis patients. Patients with PsA are at risk for decreased quality of life due to both joint and skin symptoms, impaired physical function and disease progression. Treatments include non-steroidal anti-inflammatory drugs, conventional systemic disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, and biologic agents, including tumor necrosis factor-α inhibitors. The most recently introduced treatment option is apremilast, an oral phosphodiesterase 4 inhibitor.MethodsThis review provides an in-depth discussion of apremilast's mechanism of action, and evidence of its clinical efficacy and safety from the Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) phase III pivotal clinical trials (PALACE 1, 2, and 3).ResultsThese trials demonstrate that apremilast is effective for the treatment of active PsA, despite prior conventional DMARDs or biologic treatment. The primary efficacy end point, a 20% improvement from baseline in modified American College of Rheumatology response criteria at Week 16, was achieved by significantly greater proportions of patients treated with apremilast 20 mg twice daily (BID) and apremilast 30 mg BID versus placebo in PALACE 1, 2, and 3. Improvements in this and other clinical and patient-reported end points, including swollen and tender joint counts, Psoriasis Area and Severity Index score, physical function, and quality of life, were maintained, extending over 52 weeks of treatment among patients initially randomized to apremilast. Apremilast's safety profile has been acceptable, with diarrhea and nausea being the most common adverse events, with no evidence for an increased risk of infection or need for laboratory monitoring. The PALACE pivotal data indicate that apremilast presents a new option for the treatment of PsA that may be appropriate for use early in the treatment ladder. Ongoing PALACE open-label extension trials of up to 4 years will characterize the long-term clinical effects and safety of apremilast therapy.FundingCelgene Corporation, Summit, NJ, USA.

Project description:IntroductionPsoriatic arthritis (PsA) occurs in 10%-15% of people with psoriasis and accounts for 10%-20% of early arthritis clinics referral. Only a few prognostic factors of therapeutic response in patients with PsA have been identified. In the last years, the role of imaging has grown up and the European League Against Rheumatism recognised that ultrasound (US) has higher sensitivity than clinical examination to detect inflammatory disease activity. The aims of the Ultrasound in PSoriatic arthritis TREAtMent (UPSTREAM) study are to integrate clinic and US in order to inform whether US has provide an added prognostic value in PsA.Methods and analysisUPSTREAM is an observational prospective cohort study enrolling patients with PsA having clinically active joint disease and starting a new course of therapy. The primary objective is to evaluate the additional value of US over clinical examination in detecting patients achieving minimal disease activity after 6 months. Data will be obtained at baseline and at standard clinical follow-up visits. Patient's clinical assessment will be performed according to the core set proposed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis-Outcome Measures in Rheumatology. Sonographic evaluations will be performed by expert sonographers in 42 joints, 36 tendons, 12 entheses and 2 bursae, according to a score that will be purposely developed for PsA by the US Study Group of the Italian Society for Rheumatology. The UPSTREAM study will identify clinical and US predictors of response to treatment in patients with PsA and active peripheral arthritis starting a new course of therapy.Ethics and disseminationEthic approval for this study has been obtained from the institutional review board (IRB)/independent ethics committee (IEC) Comitato Etico Lazio 1 (Prot. N 198 02-02-2017) and then locally from the IRB/IEC of each participating centre. Results will be published in relevant scientific journals and be disseminated in international conferences. Fully anonymised data will be accessible from authors upon request.Trial registration numberNCT03330769; Pre-results.

Dataset Information

Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study.

Background

Methods

Results

Conclusions

Publications

Predictors of DAPSA Response in Psoriatic Arthritis Patients Treated with Apremilast in a Retrospective Observational Multi-Centric Study.

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