The last patient completed the study on July 6, 2018
The last patient completed the study on July 6, 2018. a mean SD age of 48.4 13.1 years, and the mean SD duration of PsA was 3.2 6.3 years (median 0.6 years). ACR20 and MDA response rates at week 24 were significantly greater in patients who received etanercept monotherapy compared with those who received methotrexate Cisatracurium besylate monotherapy (ACR20, 60.9% versus 50.7% of patients [= 0.029]; MDA, 35.9% versus 22.9% of patients [= 0.005]), and both were significantly greater in the combination therapy group compared with the methotrexate monotherapy group at week 24 (ACR20, 65.0% versus 50.7% of patients [= 0.005]; MDA, 35.7% versus 22.9% of patients [= Cisatracurium besylate 0.005]). Other secondary outcomes (ACR50 and ACR70 response rates, proportions of patients achieving a Very Low Disease Activity score, and PsA disease activity scores) showed between\group differences that were consistent with the primary and key secondary end point results. Furthermore, patients in both etanercept treatment arms showed less radiographic progression at week 48 compared with patients who received methotrexate monotherapy. Outcomes were comparable in the combination therapy Cisatracurium besylate and etanercept monotherapy groups, except for some skin end points. No new safety signals were seen. Conclusion Etanercept monotherapy and combination therapy with etanercept and methotrexate showed greater efficacy than methotrexate monotherapy in patients with PsA, according to the ACR and MDA response rates and extent of radiographic progression at follow\up. Overall, combining methotrexate and etanercept did not improve the efficacy of etanercept. Introduction Psoriatic arthritis (PsA) is usually a chronic, systemic inflammatory arthritis of the peripheral joints and axial skeleton that is commonly associated with psoriasis 1. Clinical manifestations include dactylitis, enthesitis, and nail changes, as well as joint erosions frequently seen on radiographs 1. PsA occurs in up to 30% of patients with psoriasis 2. The annual incidence of PsA in patients with psoriasis has been reported to be 1C3% 3, 4, 5. Early treatment of PsA may help prevent the impaired function and deformities caused by Cisatracurium besylate joint destruction 6, 7, 8. Brokers used to treat PsA include disease\modifying antirheumatic drugs (DMARDs) such as methotrexate HOX1I and tumor necrosis factor (TNF) inhibitors 9, 10. Additional agents that have recently been approved for use in PsA include biologic inhibitors of the interleukin\12 (IL\12)/IL\23 and IL\17 pathways 11, 12, 13 and small molecule inhibitors of janus kinase 14 and phosphodiesterase 4 15. Although methotrexate is usually widely used to treat PsA and is approved by the US Food and Drug Administration (FDA) for use in psoriasis, it is not approved by the FDA for the treatment of PsA. Therefore, there is a need to better understand its efficacy in PsA 16, 17, 18. Prior trials comparing methotrexate with a biologic agent included patients who were inadequate responders to methotrexate 19, thus limiting the ability to clearly understand the efficacy of methotrexate in comparison with an established biologic therapy in methotrexate\naive patients. In the Remicade Study in Psoriatic Arthritis Patients of Methotrexate\Naive Disease (RESPOND) trial 20, investigators studied the efficacy of methotrexate in methotrexate\naive patients, but it was an open\label study that compared methotrexate with infliximab in combination with methotrexate, obscuring the ability to directly compare the efficacy of methotrexate and infliximab as monotherapies. The Methotrexate in Psoriatic Arthritis (MIPA) study, a randomized clinical trial comparing methotrexate with placebo in methotrexate\naive patients, failed to demonstrate statistically significant differences between the 2 study arms at 24 weeks 21. However, the overall findings were inconclusive, possibly because of a high dropout rate and use of a submaximal methotrexate target dosage of 15 mg/week 21. The efficacy of TNF inhibitors has been exhibited in PsA 22, 23, 24, 25, 26, 27, but the benefit of combining methotrexate and TNF inhibitors remains unclear. In rheumatoid arthritis, the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) study 28 (and analogous trials with other TNF inhibitors) have established that methotrexate used in combination with a TNF inhibitor increases the efficacy of the TNF inhibitor. No comparable study has been conducted in PsA, and results of observational studies have suggested that, unlike in rheumatoid arthritis, no additional efficacy is usually added by combining methotrexate with a TNF inhibitor in PsA 29, 30. We therefore undertook the current randomized, controlled trial to examine the comparative.