(19-21) The most recent trial, Methotrexate in Psoriatic Arthritis (MIPA), failed to demonstrate a statistically significant superiority of MTX over placebo in the study's primary endpoint, the Psoriatic Arthritis Response Criteria (PsARC
), or ACR 20, DAS28, swollen or tender joint count, or acute phase reactants at 3 or 6 months but did show superiority at 6 months in patient and physician global measures.
PsARC response was achieved by 59% of leflunomide-treated patients versus 29% of patients treated with placebo (p < 0.0001).
At 3 months, 87% of the etanercept-treated patients and 23% of the control group achieved the PsARC response, while 73% of patients in the etanercept group and 13% in the placebo group achieved the ACR20 response.
The results showed a 72% PsARC response at 3 months and a 70% response at 6 months, with the corresponding placebo responses of 31% and 24%, respectively (p < 0.001).
Psoriatic arthritis response criteria (PsARC), the primary endpoint, was met by 59% of leflunomide-treated patients compared with 29.7% of placebo treated patients (P<.0001).
Table 2 Psoriatic Arthritis Outcome Measures (28) Arthritis response ACR Response Criteria (including DIP and CMC joints) Psoriatic Arthritis Response Criteria (PsARC) Disease Activity Score (DAS) Radiographic assessment Modified Sharp Modified van der Heijde/Sharp Skin response Psoriasis Area and Severity Index (PASI) Dermatologist Static Global Physician Global Assessment (PGA) of Psoriasis QOL/function improvement Short-Form 36 Health Survey (SF-36[R]) Health Assessment Questionnaire (HAQ) Disability Index Dermatology Life Quality Index (DLQI) Functional Assessment of Chronic Illness Therapy (FACIT)