Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A department of veterans affairs cooperative study

Clegg, Daniel O.; Reda, Domenic J.; Mejías, Edwin; Cannon, Grant W.; Weisman, Michael H.; Taylor, Thomas H.; Budiman‐Mak, Elly; Blackburn, Warren D.; Vasey, Frank B.; Mahowald, Maren L.; Cush, John J.; Schumacher, H. Ralph; Silverman, Stuart L.; Alepa, F. Paul; Luggen, Michael E.; Cohen, M. R.; Makkena, Rama; Haakenson, Clair; Ward, Richard H.; Manaster, B.J.; Anderson, Robert J.; Ward, John; Henderson, William G.

doi:10.1002/art.1780391210

Cited by 413 publications

(241 citation statements)

References 11 publications

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“…In this multicenter, randomized, doubleblind, placebo-controlled trial, 405 patients were randomized in a blinded manner (1:1.3:1.3) by a centralized interactive voice response system (ClinPhone, Princeton, NJ) to receive subcutaneous injections of placebo, golimumab 50 mg, or golimumab 100 mg at weeks 0, 4,8,12,16, and 20. Randomization was stratified by baseline MTX use (yes/no).…”

Section: Methodsmentioning

confidence: 99%

“…The Psoriatic Arthritis Response Criteria (PsARC) (12) and Disease Activity Score in 28 joints (DAS28) using the CRP level (DAS28-CRP) (13,14) were employed; dactylitis, enthesitis, and morning stiffness were also assessed. The presence and severity of dactylitis were scored on a scale of 0-3, where 0 ϭ no dactylitis and 3 ϭ severe dactylitis, in each digit of the hands and feet.…”

Section: Methodsmentioning

confidence: 99%

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Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Kavanaugh¹,

McInnes²,

Mease³

et al. 2009

Arthritis & Rheumatism

564

489

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Objective. To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods. Adult patients withPsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n ‫؍‬ 113), golimumab 50 mg (n ‫؍‬ 146), or golimumab 100 mg (n ‫؍‬ 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic nail disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index).Results. At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric nail disease, and the PsAClinicalTrials.gov identifier: NCT00265096.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Kavanaugh¹,

McInnes²,

Mease³

et al. 2009

Arthritis & Rheumatism

564

489

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“…Controlled trials of sulfasalazine, methotrexate, and gold have shown only marginal benefit compared with placebo in treating PsA (19,20,(25)(26)(27). Of these, only methotrexate had a marginal effect on the skin lesions of psoriasis (25).…”

Section: Discussionmentioning

confidence: 99%

“…Other end points included the ACR50 and ACR70 responses and the Psoriatic Arthritis Response Criteria (PsARC), a composite measure of patient's and physician's global assessments and tender and swollen joint scores (19). The effect of etanercept on psoriasis was measured as improvement in target lesions, in the dermatologist's static global assessment of psoriasis, and in the Psoriasis Area and Severity Index (PASI 50 and PASI 75) (20).…”

Section: Methodsmentioning

confidence: 99%

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

Mease¹,

Kivitz²,

Burch³

et al. 2004

Arthritis & Rheumatism

816

529

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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.

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“…Two other double-blind studies recently demonstrated the safety of SSZ in psoriatic arthritis and trends favoring SSZ for improved clinical outcome. The first study, performed in the United States, concerned 221 psoriatic arthritis patients treated with SSZ (2 &day) or placebo for 36 weeks (8). There were trends favoring SSZ for physician's overall assessment, patient's overall assessment, number of painful and swollen joints, and decreases in the ESR.…”

Section: To the Editormentioning

confidence: 99%

Sulfasalazine in psoriatic arthritis: A new or established indication?

Goupille

Valat

1996

Arthritis & Rheumatism

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Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A department of veterans affairs cooperative study

Cited by 413 publications

References 11 publications

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

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

Sulfasalazine in psoriatic arthritis: A new or established indication?

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