A phase III study indicates more than two-thirds of patients with moderate to severe plaque psoriasis receiving two injections of the monoclonal antibody ustekinumab achieve at least a 75% reduction in psoriasis after 12 weeks.

Dr. Craig Leonardi of St. Louis University and colleagues randomly assigned 1,230 psoriasis patients to receive subcutaneously administered placebo or ustekinumab 45 mg or 90 mg at baseline and four weeks, followed by the same dose every 12 weeks. The primary endpoint was the proportion of patients who achieved at least a 75% reduction in psoriasis at week 12 as measured by the Psoriasis Area and Severity Index (PASI 75).

At week 12, 67% of patients in the 45 mg group and 76% of patients treated with 90 mg achieved PASI 75, compared with 4% of patients receiving placebo. Moreover, 42% of patients in the 45 mg group and 51% in the 90 mg group achieved PASI 90, or nearly complete clearance of psoriasis, compared with 1% of patients receiving placebo. Also at week 12, 37% of patients on 45 mg and 39% of those on 90 mg achieved a Dermatology Life Quality Index score of zero, indicating no impact of psoriasis or the treatment on quality of life, compared with 1% of those on placebo. All comparisons with placebo were statistically significant.

Discontinuations due to an adverse event occurred in 0.2% and 1% of patients in the low- and high-dose ustekinumab groups, compared with 2% of patients on placebo.

Ustekinumab, also known as CNTO 1275, targets the cytokines interleukin-12 and interleukin-23. It is being developed by Centocor, Inc., a subsidiary of Johnson & Johnson.

Reference: 21st World Congress of Dermatology, Sept. 30-Oct. 5, 2007, Buenos Aires.

Narrow-band UVB works for vitiligo

Despite some drawbacks, narrow-band ultraviolet B (NB-UVB) treatment is safe and effective for vitiligo, according to a review of the first 50 patients treated with this technique at the Photoderm Clinic in Ottawa.

NB-UVB was administered at least twice a week. More than 70% of patients had a “very good” rating for skin repigmentation on their face and nearly 60% had a “very good” rating for their body, but more than 80% had a “poor” rating for their hands and feet. For treatment satisfaction, 48% of physicians and 50% of patients reported a “very good” grading, while 24% of physicians and 22% of patients reported a “good” grading.

“Patient satisfaction is really the bottom line here,” said Dr. Jean-Pierre DesGroseilliers, a study author and professor of medicine at the University of Ottawa. “What I do is take the first 30 treatments, take a digital photograph before the first treatment, and then the patient and I decide whether to continue treatment or not.” He said the long duration of treatment is one of the major drawbacks. “The patient needs to be committed to this treatment not for weeks but for months.” As a result, he recommends NB-UVB only for those who are truly committed, have vitiligo on their face and neck, and have darker skin.

Reference: 82nd annual conference of the Canadian Dermatology Association, Toronto, June 29-July 4, 2007.

Teens' stress levels linked with acne severity

Teenagers under high levels of psychological stress are more likely to have increased acne severity, a study of adolescents in Singapore has shown.

Dr. Gil Yosipovitch of Wake Forest University in Winston-Salem, N.C., and his colleagues asked 94 secondary school students, mean age 14.9 years, to report on their stress levels prior to mid-year examinations (high stress) and again during the summer holidays (low stress). Sebum measurements did not differ significantly between the high- and low-stress conditions; however, there was a statistically significant positive correlation between stress levels and severity of acne papulopustulosa, but not acne comedonica.

“Our research suggests acne severity associated with stress may result from factors other than sebum quantity,” Dr. Yosipovitch said in a news release. “It’s possible that inflammation may be involved.”

The study was done in Singapore to minimize fluctuation of sebum production with variations in temperature and humidity.

Reference: Yosipovitch G, Tang M, Dawn AG, et al. Study of psychological stress, sebum production and acne vulgaris in adolescents. Acta Derm Venereol. 2007;87(2):135-9.

Etanercept cuts psoriasis severity in children

A new study indicates etanercept (Enbrel) is a safe and effective treatment for psoriasis in pediatric patients.

The three-phase trial recruited 211 patients, ages four to 17 years, with moderate to severe plaque psoriasis. During the first phase, participants were randomly assigned to a double-blind 12-week course of either once-weekly etanercept injections at a dose of 0.8mg/kg (maximum 50 mg) or placebo. At the end of this phase, patients in the treatment group had significantly better psoriasis area and severity index (PASI) scores, with 57% of the treated group achieving PASI 75, indicating 75% improvement. Only 11% of placebo patients achieved PASI 75.

All patients then switched to 24 weeks of open-label treatment with etanercept. During this phase, 68% of patients who had been in the treatment group and 65% of those who had been in the placebo group achieved PASI 75. For the third phase, 138 patients were re-randomized to treatment or placebo. During this phase, response was lost in 42% of the placebo patients.

Four serious adverse events, including three infections, occurred in three patients during treatment with open-label etanercept, but all resolved without sequelae.

“It’s wonderful to have a new option that appears to be both efficacious and safe in this population,” said study author Dr. Amy Paller of the Northwestern University School of Medicine in Chicago. “We had kids who never had worn shorts or a T-shirt in their memory because they were so embarrassed about the lesions on their arms and legs, who are now wearing prom gowns.”

The trial was funded by Immunex, a subsidiary of Amgen, and by Wyeth Pharmaceuticals.

Reference: Paller AS, Siegfried EC, Langley RG, et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008 Jan 17;358(3):241-51.

Look for 'ugly ducklings' when screening for melanoma

Preliminary findings suggest the “ugly duckling” sign may be a useful melanoma screening strategy for primary health-care providers and even for skin self-examination, according to Dr. Alon Scope of the Memorial Sloan-Kettering Cancer Center in New York and colleagues.

The ugly ducking concept was introduced in 1998 by French physicians who said moles in an individual patient generally share common characteristics, and a mole considered atypical by traditional melanoma criteria such as irregular borders or colours should not be considered for removal unless it also an “ugly duckling” mole that does not resemble its “brother nevi” in a particular patient.

Dr. Scope’s team put this concept to the test by asking 34 people, including dermatologists, nurses and nonclinical medical staff, to evaluate whether images of the backs of 12 patients showed any lesions that differed from other moles in the same patient. The patients had at least eight atypical moles, and in five patients one of the lesions was a histologically confirmed melanoma.

All five melanomas and only three of 140 benign lesions (2.1%) were perceived as ugly ducklings by at least two-thirds of participants.

The sensitivity of the ugly duckling sign for melanoma detection was 0.9 for the whole group, 1.0 for pigmented lesion experts, 0.89 for general dermatologists, 0.88 for nurses and 0.85 for nonclinicians.

Reference: Scope A, Dusza SW, Halpern AC, et al. The “ugly duckling” sign: agreement between observers. Arch Dermatol. 2008 Jan;144(1):58-64.