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Adalimumab for severe psoriasis and psoriatic arthritis: An open-label study in 30 patients previously treated with other biologics

https://doi.org/10.1016/j.jaad.2006.12.003Get rights and content

Background

Psoriasis is a chronic, genetically determined, immune-mediated, inflammatory skin disease affecting approximately 2% to 3% of the Caucasian population. Previously reported data demonstrated adalimumab to be an efficacious treatment of psoriatic arthritis and plaque-type psoriasis. Adalimumab is a fully human monoclonal antibody IgG1 against tumor necrosis factor alpha.

Objective

To evaluate the efficacy and safety of adalimumab, in the treatment of psoriasis patients whose disease is refractory to treatment with other biologic agents.

Patients and methods

Thirty patients affected by plaque-type psoriasis with or without psoriatic arthritis, unresponsive to conventional and biologic systemic treatments were enrolled. Adalimumab was administered in monotherapy, at a dosage of 40 mg, subcutaneously, once a week.

Results

At week 12, 26 of 30 patients (87%) achieved Psoriasis Area and Severity Index (PASI) 75; at week 24, 25 of 30 patients (83%) achieved PASI 75. Concerning psoriatic arthritis, at week 24, the mean Health Assessment Questionnaire score improved from 0.99 to 0.2, Ritchie articular index from 10.15 to 2, and Pain Visual Assessment Score from 6.32 to 1.2. Furthermore, therapy with adalimumab considerably enhanced patients' quality of life as assessed by two measures (Dermatology Life Quality Index, Psoriasis Disability Index). Adalimumab was generally safe and well tolerated.

Limitations

This is not a randomized placebo-controlled study and is restricted to a small number of patients.

Conclusions

In our experience, although preliminary, monotherapy with adalimumab 40 mg weekly proved to be an effective and safe treatment for the management of plaque-type psoriasis and psoriatic arthritis, with a rapid onset of action in patients whose disease had been refractory to both conventional and biologic agents.

Section snippets

Patients

Thirty patients (20 males and 10 females) affected by plaque-type psoriasis, with a Psoriasis Area and Severity Index (PASI) score ranging from 3 to 67.2, (median PASI score, 16.4; PASI interquartile range, 14.5) were enrolled. Nineteen of these patients suffered also from psoriatic arthritis. Some of the patients suffering from psoriatic arthritis were enrolled in the study, although they presented a low PASI score (PASI ≤ 10), while all patients suffering from plaque-type psoriasis had a PASI

Results

Twenty-seven of 30 patients concluded the 24-week treatment. Three patients withdrew from the study, one at the 12th, one at the 16th, and one at the 20th week, because of lack of efficacy (PASI 50 not achieved or maintained beyond week 12). In those patients who continued, significant improvement in PASI score was seen after 4 weeks of treatment (reduction of mean PASI score from 19.2 to 8.9) and the efficacy continued to improve at week 8. At week 12, 27 of 30 patients (90%) achieved an

Discussion

Systemic therapy for moderate to severe psoriasis has previously consisted largely of immunosuppressive agents such as methotrexate and cyclosporine. Increasing insight into the immunopathogenesis of psoriasis has led to new developments in the field of psoriasis pharmacotherapy. The current pathogenic model is based on a type 1 immune response mediated by type 1 helper T-cell and type 1 cytotoxic T-cell lymphocytes secreting a specific cytokine profile (interferon-γ, TNF-α, and interleukin 2).

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    Supported in part by the Italian Ministry of Health (Prog. Finalizzati Regione Lazio).

    Disclosure: Dr S. Chimenti has served as a consultant and speaker for Wyeth, Centocor, and Schering-Plough.

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