A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment

Study Overview
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Brief Summary
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Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology. The study will include patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study, which will not occur earlier than 6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy will be made independently by the physician. Before entering the study, all patients shall sign an informed consent to participate in the study, including permission to retrieve data from their medical records and to complete questionnaires regarding their quality of life. To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all consecutive patients who attend to a routine follow-up visit and have been prescribed apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection

Official Title
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Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)

Conditions
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Arthritis, Psoriatic

Intervention / Treatment
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* Drug: Apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women older than 18 years. Patients diagnosed with psoriatic arthritis according to the CASPAR criteria*. Patients who, following the routine clinical practice, initiated treatment with apremilast 6 months (±4 weeks) before their inclusion in the study. Patients naive to biologic treatments. Exclusion Criteria: Patients who reject to sign the informed consent. Patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit or for the duration of apremilast treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriatic Arthritis patients on Apremilast<br>Patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration. | Drug: Apremilast<br>* Apremilast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment persistence at 6 months after initiating apremilast treatment | Percentage of patients still being treated with apremilast after 6 months of initiating treatment | Up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics | Description of the demographic at time of initiating treatment with apremilast | Up to approximately 6 months | 
| To describe the characteristics of apremilast treatment (i.e., dosage and regimen) in patients with PsA who start treatment according to the routine clinical practice. | To capture the changes in dose and regimen of apremilast. | Up to approximately 12 months | 
| To assess the persistence of apremilast treatment after 12 months of treatment start | Percentage of patients still being treated with apremilast after 12 months of initiating treatment | Up to approximately 12 months | 
| To assess the disease activity at 6 and 12 months of treatment with apremilast. | The disease activity will be assessed by the DAPSA scale when the information available in the patient's medical record allows the estimation of the DAPSA score. Otherwise, the individual items of the DAPSA scale will be described separately. | At 6 and 12 months | 
| Changes on clinical enthesitis and dactilitis | Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast. | UP to approximately 12 months | 
| Tender joints count | Change from baseline in the joints deemed tender as per joint count assessment by physical exam. | Up to approximately 12 months | 
| Swollen joints count | Change from baseline in the joints deemed tender as per joint count assessment by physical exam. | UP to approximately 12 months | 
| Changes in the plasma concentration of C-reactive protein. | Assessment of the change in the plasma concentration of C-reactive protein after 6 and 12 months of apremilast treatment. | Up to approximately 12 months | 
| Physician Global Assessment of Disease Activity (PGA). | Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment. | Up to approximately 12 months | 
| To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast. | Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center. | UP to approximately 12 months | 
| The VITACORA-19 questionnaires | are used to assess the health-related quality of life of patients with PsA in the setting of clinical trials | UP to approximately 12 months | 
| The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires | was developed under a 13-country EULAR initiative to evaluate the impact of psoriatic arthritis in clinical practice . The version used in this study (PsAID-9) consists of 9 items addressing pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleeping disturbances, coping, and anxiety | UP to approximately 12 months | 
| Assessment of changes on affected joints | Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast. | Up to approximately 12 months | 
| Assessment of DAPSA/cDAPSA scores | Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment. | Up to approximately 12 months | 
| To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. | Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. The Pearson or Spearman correlation will be performed to evaluate the relationship between these variables | Up to approximately 12 months | 
| Adverse events (AEs) | Number participants with adverse events. | Up to approximately 12 months | 
| To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. | To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. | UP to approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Apremilast, CC-10004, Biologic Treatments