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New analyses from premarketing clinical trials show that ustekinumab (Stelara, Centocor Ortho Biotech) for moderate-to-severe chronic plaque psoriasis offers sustained efficacy and has a favorable safety and tolerability profile out to three years.
Alexa Kimball, M.D., M.P.H., was the lead author of a poster presented at the 2010 summer meeting of the American Academy of Dermatology that reported on the durable efficacy of ustekinumab (Kimball A, Goffe B, Bissonnette R, Yeilding N, Papp K. Efficacy of ustekinumab is sustained through 3 years of treatment for patients with moderate-to-severe psoriasis maintained in q12 week dosing based on body weight. Poster presented at: American Academy of Dermatology Summer Meeting 2010; August 5-8, 2010; Chicago).
The analyses, which focused on patients receiving maintenance injections every 12 weeks at a dose consistent with the body weight–based treatment recommendation for ustekinumab, included data from 379 participants in the phase 3 PHOENIX 1 study, representing 246 patients weighing less than 100 kg who were treated with ustekinumab 45 mg and 133 patients weighing more than 100 kg who received ustekinumab 90 mg.
At week 76, approximately 80 percent of patients in both dosing groups maintained a PASI 75 response, while at week 148, the PASI 75 response rate was 88 percent among patients in the ustekinumab 45 mg group and 72 percent among those receiving ustekinumab 90 mg.
"Evaluating medium and long-term efficacy and safety data is a critical part of understanding new therapies for a chronic disease such as psoriasis. It is noteworthy that about 80 percent of patients in PHOENIX 1 remained in the study at three years, and this cohort provides useful information about ustekinumab outcomes over time," says Dr. Kimball, associate professor of dermatology, Harvard Medical School, and an investigator in the ustekinumab clinical trials. "Although patients who weigh less appeared to do slightly better than their heavier counterparts over time, overall, efficacy appears to decline only incrementally in patients who were maintained on ustekinumab treatment with recommended dosing regimens."
Craig Leonardi, M.D., is also an investigator in ustekinumab clinical trials and was a coauthor of a poster analyzing ustekinumab cumulative three-year safety data from four premarketing clinical trials (Gordon K, Leonardi C, Griffiths C, et al. Ustekinumab safety update: Cumulative experience from longer term follow-up of patients treated in the ustekinumab psoriasis clinical development program. Poster presented at: 19th Congress of the European Academy of Dermatology and Venereology; October 6-10, 2010; Gothenburg, Sweden). Regarding efficacy, Dr. Leonardi says, "One of ustekinumab's unique features is its maintenance of long-term response. From a variety of perspectives, the drug performs well over several years. Whether this is a specific feature of IL12/23 blockade, ustekinumab's long half-life, its inherent potency or a combination of features is not clear. Regardless, ustekinumab-treated patients appear to be well-served over long periods of time." Dr. Leonardi is clinical professor of dermatology, Saint Louis University Medical School, St. Louis.