Composite Measures for Clinical Trials in Psoriatic Arthritis: Testing Pain and Fatigue Modifications in a UK...

Area of Science:

• Rheumatology
• Clinical Trials
• Disease Activity Measurement

Background:

• Psoriatic arthritis (PsA) composite measures are crucial for assessing disease activity.
• Existing composite measures like CPDAI and GRACE may not fully capture patient experience.
• Incorporating pain and fatigue could potentially enhance these measures.

Purpose of the Study:

• To evaluate the impact of adding pain and fatigue to the CPDAI and GRACE composite measures in PsA.
• To determine if modified measures show improved responsiveness and discrimination compared to original versions.
• To assess expert consensus on composite measures for PsA clinical trials.

Main Methods:

• A UK multicenter observational study assessed PsA patients over 6 months.
• Pain and fatigue scales were added to CPDAI and GRACE.
• Modified and original measures were compared against PASDAS and DAPSA for responsiveness and discrimination.
• GRAPPA members voted on recommended composite measures and treatment targets.

Main Results:

• Modified CPDAI and GRACE showed no significant improvement in responsiveness or discrimination.
• The PASDAS demonstrated superior responsiveness and discrimination.
• A majority of GRAPPA members favored the PASDAS for clinical trials and minimal disease activity (MDA) as the target.

Conclusions:

• Adding pain and fatigue to CPDAI and GRACE does not enhance their utility in detecting PsA disease status requiring treatment.
• The PASDAS is recommended as the preferred composite measure for PsA clinical trials.
• Minimal disease activity (MDA) is the proposed treatment target.