Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: A multinational, double‐blind, randomized, placebo‐controlled clinical trial

Kaltwasser, J. P.; Nash, Peter; Gladman, Dafna D.; Rosen, Cheryl F.; Behrens, Frank; Jones, Peter; Wollenhaupt, J.; Falk, Franziska G; Mease, Philip J.

doi:10.1002/art.20253

Cited by 371 publications

(225 citation statements)

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“…The incidences of adverse events, serious adverse events, and infections were similar between treatment groups. Overall, the safety of adalimumab was similar to that reported in studies of adalimumab in RA (25)(26)(27) and to that reported in previous studies of other therapies in PsA (11,20,50,51).…”

Section: Discussionsupporting

confidence: 86%

“…A meta-analysis of published, randomized, placebo-controlled studies, prepared by the Cochrane Collaboration, found that among the traditional, nonbiologic DMARDs, only parenteral high-dose methotrexate (MTX) and sulfasalazine had efficacy in patients with PsA (10). A recently published study demonstrated a moderate effect of treatment with leflunomide in PsA patients (11).…”

mentioning

confidence: 99%

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Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Mease

Gladman

Ritchlin

et al. 2005

Arthritis & Rheumatism

827

629

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Objective. Adalimumab, a fully human, antitumor necrosis factor monoclonal antibody, was evaluated for its safety and efficacy compared with placebo in the treatment of active psoriatic arthritis (PsA).Methods. Patients with moderately to severely active PsA and a history of inadequate response to nonsteroidal antiinflammatory drugs were randomized to receive 40 mg adalimumab or placebo subcutaneously every other week for 24 weeks. Study visits were at baseline, weeks 2 and 4, and every 4 weeks thereafter. The primary efficacy end points were the American College of Rheumatology 20% improvement (ACR20) response at week 12 and the change in the modified total Sharp score of structural damage at week 24. Secondary end points were measures of joint disease, disability, and quality of life in all patients, as well as the severity of skin disease in those patients with psoriasis involving at least 3% of body surface area.Results. At week 12, 58% of the adalimumabtreated patients (87 of 151) achieved an ACR20 response, compared with 14% of the placebo-treated patients (23 of 162) (P < 0.001). At week 24, similar ACR20 response rates were maintained and the mean change in the modified total Sharp score was ؊0.2 in patients receiving adalimumab and 1.0 in those receiving placebo (P < 0.001). Among the 69 adalimumabtreated patients evaluated with the Psoriasis Area and Severity Index (PASI), 59% achieved a 75% PASI improvement response at 24 weeks, compared with 1% of the 69 placebo-treated patients evaluated (P < 0.001). Disability and quality of life measures were also significantly improved with adalimumab treatment compared with placebo. Adalimumab was generally safe and welltolerated.Conclusion. Adalimumab significantly improved joint and skin manifestations, inhibited structural changes on radiographs, lessened disability due to joint damage, and improved quality of life in patients with moderately to severely active PsA.Psoriatic arthritis (PsA) is a chronic, inflammatory arthritis occurring in individuals with psoriasis. Psoriasis occurs in 2-3% of the US population (1). The reported range of prevalence of PsA in patients with psoriasis is 6-39%, depending on the population studied

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Section: Discussionsupporting

confidence: 86%

mentioning

confidence: 99%

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Mease

Gladman

Ritchlin

et al. 2005

Arthritis & Rheumatism

827

629

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“…Leflunomide is the most well researched of the DMARDs for PsA, with a placebocontrolled randomised controlled trial of 190 patients. 25 However, leflunomide is not commonly used in clinical practice.…”

Section: Pharmaceutical Therapymentioning

confidence: 99%

Psoriatic arthritis: state of the art review

2017

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Psoriatic arthritis (PsA) accounts for around 20% of referrals to the early arthritis clinic and presents a signifi cant diagnostic and management challenge. Early diagnosis is important to prevent long term functional disability and to ensure optimal management of arthritis and key comorbidities. From the rheumatologist's perspective, the differential diagnosis includes rheumatoid arthritis, gout and other infl ammatory arthritides. Once diagnosed, it is essential to assess the disease fully, including arthritis, enthesitis, dactylitis, skin/ nail disease and axial involvement. Using this information, appropriate treatment can be planned using therapies that are effective at treating the relevant domains of disease. Despite poor data, traditional disease-modifying anti-rheumatic drugs are commonly used and have been effective in observational studies. Following tumour necrosis factor inhibitors, which have proven excellent effi cacy in multiple domains of PsA, new biologics are available or in development and will improve treatment options for people with refractory PsA. IntroductionIn 1964, psoriatic arthritis (PsA) was recognised as a separate disease by the American Rheumatism Association (now the American College of Rheumatology), and is now included as a member of the spondyloarthropathy spectrum.1 PsA was initially defined by Moll and Wright as 'an inflammatory arthritis in the presence of psoriasis with a usual absence of rheumatoid factor', 2 but newer more robust classification criteria are discussed in this article. Why is it important to recognise PsA?Although PsA was thought initially to be a relatively benign disorder, registry data has shown the destructive and progressive nature of the disease; 4 it has a similar impact on quality of life and functional ability as in rheumatoid arthritis. 5 ABSTRACT Psoriatic arthritis: state of the art reviewIn recent years, the additional burden of increased mortality and significant cardiovascular comorbidity has also been identified. 6 Despite this, identification and treatment are still not optimal. There are significant delays in diagnosis for the majority of patients (typically, in screening studies, up to 50% of established cases have not previously been identified).7 Delay in diagnoses of 6 and 12 months have been shown to impact on long-term joint damage and functional disability. 8,9 DiagnosisPsA is a heterogeneous condition with musculoskeletal involvement, including arthritis, enthesitis, dactylitis and axial involvement as well as potential skin and nail disease. Different patterns of involvement of PsA can mimic different inflammatory arthritides.For the rheumatologist, a patient presents with inflammatory arthritis and the differential diagnosis can include rheumatoid arthritis, crystal arthropathies and other inflammatory arthritides. When differentiating from rheumatoid arthritis, particularly in polyarticular PsA, there are a number of features Key pointsPsoriatic arthritis is an heterogeneous disease with multiple musculoskeletal and dermatol...

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“…In particular, studies analyzing the efficacy of oral DMARDs have shown no improvement over placebo in the case of methotrexate [26,27] and small effect sizes for sulfasalazine [28]. One phase IIb study did reveal efficacy for leflunomide for the joints only, but a phase III study was never performed [29]. Likewise, a large, retrospective US database looked at patients treated with DMARDs (n=1698) vs. biologics (n=3263) over a 4-year period found that 69 % of patients in the DMARD group required a change in therapy.…”

Section: Challenges In the Treatment Of Psoriatic Arthritismentioning

confidence: 99%