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Author Spotlight: Self-Assessment Protocol for Predicting Psoriatic Arthritis in Psoriasis Patients
Published on: March 1, 2024
Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease: A
Christine Ballegaard1, Tanja S Jørgensen2, Marie Skougaard2
1Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, and Gentofte Hospital, Copenhagen, Denmark.
Objective:
To assess the importance of trial characteristics as contextual factors when evaluating the treatment effect of targeted therapies for patients with psoriatic disease.
Methods:
We identified randomized controlled trials (RCTs) evaluating targeted therapies approved for psoriatic arthritis (PsA) and psoriasis (8 biologics and apremilast). The effect of targeted therapies was analyzed in the 2 psoriatic conditions combined by using drug retention as a common outcome, and separately by using the American College of Rheumatology 20% improvement criteria (ACR20) for PsA and the Psoriasis Area Severity Index 75% improvement score (PASI75) for psoriasis. We explored potential effect modification of trial characteristics in stratified and meta-regression analyses. Odds ratios (ORs) were calculated and compared among the trial eligibility criteria via the ratio of ORs.
Results:
Forty-eight PsA and psoriasis trials (51 comparisons; 17,737 patients) were eligible. Overall retention was OR 2.16 (95% confidence interval [95% CI] 1.70-2.75) with higher odds for PsA trials compared with psoriasis trials (ratio of ORs 2.55 [95% CI 1.64-3.97]). The eligibility criteria "targeted therapy history," "minimum required disease duration," "required negative rheumatoid factor," and "required Classification Criteria for Psoriatic Arthritis criteria" were of importance for achieving ACR20 in PsA. The eligibility criterion "minimum required disease duration" was of importance for achieving PASI75 in psoriasis. A total of 7 PsA trials had rescue before time-point-of-retention reporting (adaptive trials).
Conclusion:
From this exploratory meta-epidemiologic study, we now have evidence from RCTs to support the notion that patients with PsA are more likely to adhere to targeted therapies compared to patients with psoriasis. Furthermore, we identified a few contextual factors of importance in regard to achieving ACR20 in PsA trials and PASI75 in psoriasis trials.
Insights
Patients with psoriatic arthritis (PsA) showed better adherence to targeted therapies than those with psoriasis. Specific trial criteria influenced treatment outcomes in PsA and psoriasis studies.
Area of Science:
- Rheumatology and Dermatology
- Clinical Trial Analysis
- Pharmacotherapy Efficacy
Background:
- Psoriatic disease encompasses psoriatic arthritis (PsA) and psoriasis, both managed with targeted therapies.
- Evaluating treatment effectiveness requires understanding contextual factors within clinical trials.
- Drug retention and specific clinical response criteria (ACR20, PASI75) are key outcome measures.
Purpose of the Study:
- To assess the impact of trial characteristics on the effectiveness of targeted therapies in psoriatic disease.
- To identify specific eligibility criteria that influence treatment outcomes in randomized controlled trials (RCTs).
Main Methods:
- Systematic review and meta-analysis of RCTs for targeted therapies in PsA and psoriasis.
- Analysis of drug retention, ACR20 (for PsA), and PASI75 (for psoriasis) as primary outcomes.
- Stratified and meta-regression analyses to explore effect modification by trial characteristics.
Main Results:
- Forty-eight trials (17,737 patients) were analyzed, showing higher drug retention odds in PsA trials compared to psoriasis trials.
- Specific eligibility criteria, including prior targeted therapy, disease duration, rheumatoid factor status, and classification criteria, were significant for ACR20 in PsA.
- "Minimum disease duration" was important for PASI75 in psoriasis.
- Seven PsA trials employed adaptive designs with early rescue provisions.
Conclusions:
- Patients with PsA demonstrate greater adherence to targeted therapies than those with psoriasis.
- Identified key trial eligibility criteria that are important for achieving treatment efficacy (ACR20 and PASI75) in PsA and psoriasis, respectively.
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