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Infliximab More Effective Than Methotrexate in Patients With Moderate to Severe Plaque Psoriasis: Presented at EADV

By Jenny Powers

BERLIN -- October 14, 2009 – A greater percentage of patients with moderate to severe plaque psoriasis taking infliximab (IFX) achieved a Psoriasis Area Severity Index 75 (PASI 75) at 16 weeks compared with patients treated with methotrexate (MTX), according to study results presented at the 18th Congress of the European Academy of Dermatology and Venereology (EADV). Improved quality of life was consistently higher in the infliximab group.

Kristian Reich, MD, Dermatologikum Hamburg, Hamburg, Germany, and an international team of researchers presented study data here on October 9 from a trial directly comparing the efficacy of IFX with MTX.

The primary aim of the study was to assess the effect of IFX versus MTX on health-related quality of life (HRQOL) in patients with moderate to severe plaque psoriasis, as measured by the Dermatology Life Quality Index (DLQI) and the Short-Form Health Survey (SF-36) at weeks 0, 10, 16, and 26.

This active-controlled, multicentre, open-label study enrolled a total of 868 adult patients with plaque-type psoriasis (baseline PASI score of at least 12, plus at least 10% body-surface-area involvement) who were naïve to IFX and MTX. Patients were randomised to receive IFX (n = 653; 5 mg/kg at week 0, 2, 6, 14, and 22) or oral MTX (n = 215; initially 15 mg/week, increased to 20 mg/week in patients with less than 25% change from baseline PASI score at week 6).

At all time points, a greater percentage of the patients in the IFX arm attained PASI 50/75/90 response rates than those in the MTX arm. At week 26, 77% of patients taking IFX achieved PASI 75 compared with 31% of patients taking MTX (P < .001). Greater reductions were seen in the total DLQI score for IFX compared with MTX, respectively (week 10, -11.4 vs -7.9, P < .001; week 16, -11.6 vs -8.95, P < .001; week 26, -11.3 vs -9.14, P < .004).

Greater improvements were reported for IFX compared with MTX in the component scores of the SF-36, as well, respectively (Physical: week 10, 5.15 vs 3.00, P < .001; week 16, 5.53 vs 3.76, P = .002; week 26, 4.68 vs 3.98, P = .368. Mental: week 10, 7.94 vs 5.63, P = .011; week 16, 7.85 vs 6.12, P = .064; week 26, 8.03 vs 6.72 P = .290).

Neither IFX nor MTX were associated with unanticipated safety events. IFX was well tolerated.

The authors concluded that IFX treatment led to significantly greater improvement in HRQOL over MTX in patients with moderate to severe plaque-type psoriasis, as reflected by DLQI, SF-36, and EuroQol 5 Dimension analyses. Furthermore, IFX was superior to MTX treatment both clinically and in terms of patient reported quality of life.

Funding for this study was provided by Schering-Plough.

[Presentation title: Infliximab Is Associated With Greater Improvement in Health-Related Quality of Life Versus Methotrexate for Moderate-to-Severe Plaque Type Psoriasis - the RESTORE1 Trial. Abstract P1187]

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