Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial

806

529

Objective. Etanercept has been shown to improve the articular and cutaneous manifestations of psoriatic arthritis (PsA). In this study, we further evaluated the safety, efficacy, and effect on radiographic progression of etanercept in patients with PsA.Methods. Patients with PsA (n ‫؍‬ 205) were randomized to receive placebo or 25 mg etanercept subcutaneously twice weekly for 24 weeks. Patients continued to receive blind-labeled therapy in a maintenance phase until all had completed the 24-week phase, then could receive open-label etanercept in a 48-week extension. Efficacy and safety were evaluated at 4, 12, and 24 weeks and at 12-week intervals thereafter. Radiographs of the hands and wrists were assessed at baseline and 24 weeks, at entry to the open-label phase, and after 48 weeks in the study.Results. Etanercept significantly reduced the signs and symptoms of PsA and psoriasis. At 12 weeks, 59% of etanercept patients met the American College of Rheumatology 20% improvement criteria for joint response, compared with 15% of placebo patients (P < 0.0001), and results were sustained at 24 and 48 weeks. At 24 weeks, 23% of etanercept patients eligible for psoriasis evaluation achieved at least 75% improvement in the Psoriasis Area and Severity Index, compared with 3% of placebo patients (P ‫؍‬ 0.001). Radiographic disease progression was inhibited in the etanercept group at 12 months; the mean annualized rate of change in the modified total Sharp score was ؊0.03 unit, compared with ؉1.00 unit in the placebo group (P ‫؍‬ 0.0001). Etanercept was well tolerated.Conclusion. Etanercept reduced joint symptoms, improved psoriatic lesions, inhibited radiographic progression, and was well tolerated in patients with PsA.

Section: Discussionsupporting

confidence: 76%

Section: Methodsmentioning

confidence: 99%

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confidence: 99%

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Etanercept treatment of psoriatic arthritis: Safety, efficacy, and effect on disease progression

Mease¹,

Kivitz²,

Burch³

et al. 2004

806

529

“…In patients with AS, TNF concentrations are elevated in the serum (3,4) and synovial tissue (5)(6)(7). Etanercept substantially reduces disease activity in patients with spondylarthropathies, as demonstrated in a study in psoriatic arthritis (8) and a pilot study in AS (9). These findings suggest that blockage of the proinflammatory effects of TNF may reduce the clinical signs and symptoms of AS and improve quality of life.…”

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confidence: 82%

Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: A randomized, controlled trial

Davis

Heijde

Braun³

et al. 2003

685

376

Results. Treatment with etanercept resulted in dramatic improvement. The ASAS20 was achieved by 59% of patients in the etanercept group and by 28% of patients in the placebo group (P < 0.0001) at week 12, and by 57% and 22% of patients, respectively, at week 24 (P < 0.0001). All individual ASAS components, acutephase reactant levels, and spinal mobility measures were also significantly improved. The safety profile of etanercept was similar to that reported in studies of patients with rheumatoid arthritis or psoriatic arthritis. The only adverse events that occurred significantly more often in the etanercept group were injection-site reactions, accidental injuries, and upper respiratory tract infections.Conclusion. Etanercept is a highly effective and well tolerated treatment in patients with active AS.Ankylosing spondylitis (AS) is an inflammatory arthritis and enthesitis involving the spine and periSupported by Immunex Corporation, Seattle, Washington, a wholly owned subsidiary

“…Only a few small, controlled clinical trials have been performed with interventions, such as sulfasalazine (4)(5)(6), methotrexate (7), and cyclosporin A (8,9). The increased awareness of the success of early, aggressive, and novel treatment strategies in RA (10,11) has encouraged an identical approach to treatment of patients who have disabling PsA, but using new modalities, such as etanercept (12). More detailed information about the effects of these regimens in PsA is needed before they can be developed further.…”

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confidence: 99%

Alefacept treatment in psoriatic arthritis: Reduction of the effector T cell population in peripheral blood and synovial tissue is associated with improvement of clinical signs of arthritis

Kraan

Kuijk

Dinant

et al. 2002

135

Objective. To investigate whether alefacept (a fully human lymphocyte function-associated antigen 3 [LFA-3]/IgG1 fusion protein that blocks the LFA-3/CD2 interaction) is able to reduce the signs and symptoms of joint inflammation in patients with active psoriatic arthritis (PsA).Methods. Eleven patients with active PsA were treated with alefacept for 12 weeks in an open-label and explorative study. Clinical joint assessment and laboratory assessments were performed at baseline and after 4, 9, 12, and 16 weeks of treatment. Serial synovial tissue (ST) biopsy specimens from an inflamed index joint (knee, ankle, wrist, or metacarpophalangeal joint) were obtained by arthroscopy at baseline and after 4 and 12 weeks of treatment.Results. At the completion of treatment, 6 of 11 patients (55%) fulfilled the Disease Activity Score (DAS) response criteria. Nine patients (82%) fulfilled the DAS response criteria at any point during the study. There was a statistically significant reduction in CD4؉ lymphocytes (P < 0.05), CD8؉ lymphocytes (P ‫؍‬ 0.05), and CD68؉ macrophages (P < 0.02) in the ST after 12 weeks of treatment compared with baseline. The ST and peripheral blood of those patients fulfilling the DAS response criteria contained more CD45RO؉ cells at baseline and displayed a significant reduction in these cells compared with nonresponding patients.Conclusion. The changes in ST, together with the improvement in clinical joint scores, after treatment with alefacept support the hypothesis that T cell activation plays an important role in this chronic inflammatory disease. Furthermore, since alefacept, a T cellspecific agent, led to decreased macrophage infiltration, the data indicate that T cells are highly involved in synovial inflammation in PsA.