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| |  Adalimumab Yields Fast and Sustainable Scalp and Nail Results in Patients With Psoriasis: Presented at EADV By Jenny Powers
BERLIN -- October 13, 2009 -- Adalimumab is as effective as adalimumab plus topical treatment in treating moderate to severe psoriasis symptoms seen in the skin, scalp, and nails, according to results of a phase 3b, multicentre, European study reported here on October 8 at the 18th Congress of the European Academy of Dermatology and Venereology (EADV). Psoriasis of the skin is often also seen in the difficult to treat areas of the nails and scalp. Diamant Thaci, MD, J.W. Goethe University, Frankfurt, Germany, reported data from the BELIEVE study (Adalimumab in Combination With Topical Treatment [Calcipotriol/Betamethasone] in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment). The 16-week study enrolled 730 patients with moderate to severe psoriasis who had failed, been intolerant of, or had contraindications to at least 2 systemic therapies. In all, 366 subjects received adalimumab (80 mg subcutaneously at week 0 and 40 mg every other week at weeks 1 to 15) and topical calcipotriol (0.5 mg/g plus betamethasone 0.5 mg/g [C/B]); 364 subjects received adalimumab plus placebo vehicle. C/B and vehicle were not applied to the scalp and nails. Following a washout period of varying length, the patients in each treatment arm received the opposite treatment. The primary aim was to determine the efficacy of adalimumab (ADA) for scalp and nail psoriasis using the Psoriasis Area and Severity Index (PASI), as determined by achieving PASI 75 at week 16. Efficacy assessments by PASI were done at baseline and weeks 2, 4, 8, 12, and 16. Subjects had a mean PASI of 19.5 and affected body surface area of 33% at baseline. At week 16, PASI 75 response was achieved by 64.8% of the ADA + C/B group versus 70.9% of the ADA + vehicle group (P = .086). Patients in both ADA groups experienced scalp (measured by Psoriasis Scalp Severity Index [PSSI]) and nail (measured by the Nail Appearance Severity Score [NAPSI]) improvements by week 8 that continued through week 16, when the mean change in PSSI was -77.2% (-100%), and the median change in NAPSI was -39.5%. The team concluded that, in addition to improvement in skin psoriasis symptoms, both scalp and nail psoriasis were clinically improved with ADA therapy. The PASI 75 score with ADA + C/B was not superior to adalimumab immunotherapy at 16 weeks, thus adalimumab alone may be as effective as in combination with topical treatment. Funding for this study was provided by Abbott Laboratories. [Presentation title: Adalimumab Plus Topical Treatment (Calcipotriol/Betamethasone) in the Treatment of Moderate to Severe Psoriasis - Effects on Skin, Scalp, and Nails: Results From BELIEVE. Abstract P824]
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