New findings to be presented from pooled analyses of the STELARA® (ustekinumab) psoriasis clinical development program showed that the safety profile of STELARA and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. Investigators also reported findings from an analysis of four placebo-controlled Phase 3 trials across patient populations on three continents and found that the efficacy and safety of STELARA in patients of Japanese, Korean and Taiwanese descent were consistent with findings previously reported in North American and European populations. Both sets of data were presented at the 22nd World Congress of Dermatology in Seoul, Korea.
Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. STELARA is currently approved in 57 countries for the treatment of moderate to severe plaque psoriasis.
"These findings are promising and support a favorable benefit-to-risk profile for STELARA with up to four years of treatment," said Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. "Ongoing studies in psoriasis and psoriatic arthritis will continue to define the safety profile of STELARA in the psoriatic population."
Pooled safety data from a total of 3,117 patients who participated in a Phase 2 STELARA trial and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT studies showed rates of adverse events (AEs) to be generally stable over time through up to four years of treatment with STELARA, with the most commonly reported AEs [greater than 5 per 100 patient years (PY)] including nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain and influenza. Observed occurrences of AEs of interest, including serious infections (0.8 and 1.32 for 45 mg and 90 mg STELARA patient groups, respectively, per 100 PY), non-melanoma skin cancer (0.70; 0.53 per 100 PY, respectively), other malignancies (0.63; 0.61 per 100 PY, respectively) and major adverse cardiovascular events (MACE) (0.42; 0.36 per 100 PY, respectively) remained generally stable during the time periods evaluated. The observed rate of malignancies (excluding non-melanoma skin cancers) was consistent with that expected in the general U.S. population, derived from the Surveillance, Epidemiology and End Results (SEER) Database. Rate of non-fatal myocardial infarction (MI) or stroke was consistent with or lower than that expected in the general U.S. population and psoriasis populations, derived from the Framingham Database and General Practice Research Database (GPRD), respectively.1
The four year safety analysis of the Phase 2, PHOENIX 1, PHOENIX 2 and ACCEPT trials evaluated the largest psoriasis-focused clinical trial safety database for a biologic reported to date, with more than 1,100 patients who have had at least three years of treatment with STELARA and more than 600 patients treated for four or more years for a total of nearly 6,800 PY.
Consistency of Responses across Different Ethnic Populations with Moderate-to-Severe Plaque Psoriasis: Results from the STELARA Psoriasis Clinical Development Program
Additional findings from a separate analysis found STELARA efficacy and safety across Asian populations with moderate to severe plaque psoriasis to be consistent with those observed in North American and European populations, according to data from PHOENIX.
"Psoriasis is an autoimmune disease that affects millions of people worldwide from all ethnic backgrounds," said Dr Jai-Il Youn, Department of Dermatology, Seoul National University, Seoul, Korea and study investigator. "These data show the consistency of response with STELARA in the treatment of psoriasis across ethnic populations. These findings are important considerations for the dermatology community."
In the four analyzed studies, patients received subcutaneous injections of STELARA 45 mg or 90 mg, or placebo at weeks 0 and 4, although only the STELARA 45 mg dose was evaluated in the PEARL trial. STELARA patients received a third dose at week 16, while placebo-treated patients crossed over to receive active treatment at weeks 12 and 16. At week 12, the primary endpoint, a 75 percent improvement as measured by the Psoriasis Area Severity Index (PASI 75), was achieved by a significantly greater proportion of patients across all studies when compared with the placebo group (P > 0.001). Among patients receiving STELARA 45 mg, 66.9 percent, 59.4 percent and 67.2 percent achieved PASI 75 in the North American/European, Japanese, Korean and Taiwanese patient populations, respectively. In patients receiving 90 mg, 72.1 percent and 67.7 percent of patients achieved PASI 75 in the North American/European and Japanese populations. Placebo rates of response were 3.5 percent, 6.5 percent and 5.0 percent in the PHOENIX 1 & 2, Japanese and PEARL trials, respectively. These responses continued to improve through week 28 across groups, with similar responses seen in placebo-treated patients following crossover to treatment with STELARA. STELARA-treated patients also demonstrated clinically meaningful improvements in quality of life, as measured by the Dermatology Life Quality Index (DLQI), at weeks 12 and 28 across the four trials.
Rates of AEs and serious AEs through week 12 were comparable overall between STELARA and placebo groups in the North American/European, Japanese, Korean and Taiwanese trials. Among patients receiving STELARA 45 mg (or 90 mg), 54.8 (49.7) percent, 65.6 (59.7) percent and 65.6 percent of patients across patient populations reported at least one AE, compared with 49.2 percent, 65.6 percent and 70.0 percent of placebo patients, respectively. Similar safety results were seen through week 28 of each trial. Please read the Important Safety Information for STELARA below.
Seoul National University