A series of 43 patients with treatment-refractory psoriatic arthritis, plaque-type psoriasis or erythrodermic psoriasis were treated with adalimumab, 40 mg, once weekly. Improvements were achieved rapidly in PASI scores as well as quality-of-life measures, and have been maintained with continued treatment for up to one year.
"These quality-of-life data provide complementary information about the efficacy of treatment, and their results support the benefits of adalimumab," Dr. Papoutsaki says.
Researchers presented their experience treating 43 patients with adalimumab, 40 mg, once weekly. The group included 29 patients with PsA, 10 patients with plaque-type psoriasis, and four patients with erythrodermic psoriasis. All patients had failed previous treatment with conventional systemic therapy (methotrexate, cyclosporine, retinoids, PUVA) and/or at least one biological agent (infliximab [Remicade, Centocor], etanercept [Enbrel, Amgen/Wyeth], efalizumab [Raptiva, Genentech]).
Three patients discontinued adalimumab therapy after 12 to 20 weeks because of lack of response, but no patients stopped therapy because of an adverse reaction. Twenty-seven patients received adalimumab for up to six months, and 15 patients had been treated for up to one year.
"Longer follow-up is needed and our experience is in a relatively small group of patients. However, the outcomes are encouraging in suggesting adalimumab is a valuable alternative for maintaining long-term control of inflammatory cutaneous diseases," says Marina Papoutsaki, M.D., a research fellow in the department of dermatology, University of Rome "Tor Vergata," directed by Prof. Sergio Chimenti, M.D.
She notes that the 40 mg weekly dose administered to the patients is twice the dose of adalimumab recommended for the treatment of PsA.
"Our decision to use this dose was based, in part, on the preliminary data of a dose-ranging phase 2 clinical trial of the efficacy of adalimumab in the long-term treatment of moderate-to-severe chronic plaque-type psoriasis that showed a higher percentage of patients who reached PASI 75 at week 24 (77 percent) in the group treated every week, and because the majority of patients in this study had already failed at least one biological agent," she says.
All patients considered for adalimumab underwent thorough screening to identify conditions that would contraindicate use of the biologic agent. They were carefully followed every four weeks after starting treatment, and their responses were measured using the PASI, the Dermatology Life Quality Index (DLQI) and the Psoriasis Disability Index (PDI). In the patients with PsA, joint disease activity was evaluated using the Health Assessment Questionnaire (HAQ).
The patients with PsA had PASI scores at baseline ranging from 4.0 to 61.8. In patients with plaque psoriasis only, baseline PASI scores ranged from 11.6 to 67.2. Mean baseline PASI score for the group was 18.0, and it decreased to 8.4 by week 4 and to 2.0 by week 12.
Achievement of a 75 percent reduction from baseline PASI (PASI-75) was the primary efficacy measure, and by week four, 25 percent of patients had already reached that outcome. Forty patients were seen at week 12, and 33 (82 percent) of those patients were PASI-75 responders. Another two patients had at least a 50 percent improvement in their PASI score, and two-thirds of the patients were PASI-90 responders.
Among 27 patients evaluated at week 24, rates of PASI-50, PASI-75 and PASI-90 responses were 93 percent, 89 percent and 85 percent. The proportions of patients achieving those outcomes at one year were 93 percent, 87 percent and 80 percent.
In all three quality-of-life instruments, significant improvements from baseline mean scores were achieved by week 12, and further improvement was seen in the mean DLQI and PDI scores by week 48. The mean HAQ score at baseline was 0.99. It improved to 0.2 at week 12 and remained at that low level at week 48.
The treatment was very well-tolerated. Other than a few patients who reported local injection site reactions, the only adverse event recorded was hyperlipidemia in two patients.
DISCLOSURES: Dr. Papoutsaki is a consultant for Schering-Plough and a speaker for Schering-Plough and Abbott.