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New efficacy and safety data from the Phase 3 PHOENIX 1 study, one of two pivotal registration trials, showed that maintenance treatment with STELARA® (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. Among responders receiving STELARA 45 mg or 90 mg and randomized to continue maintenance therapy through five years, 79 and 81 percent of patients, respectively, experienced at least a 75 percent improvement in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at the end of the treatment period. Investigators also reported a consistent benefit-to-risk profile for STELARA through five years and observed treatment with the biologic therapy to be generally well-tolerated with rates of adverse events (AEs), including infections, malignancies and cardiovascular events, remaining stable over time. The data were presented today at the 9th Annual European Academy of Dermatology and Venereology Spring Symposium in Verona, Italy.
"These data are important to the professional dermatology community as we now have five-year data—the longest continuous study evaluating a biologic in the treatment of psoriasis—that reinforce our understanding of STELARA efficacy and safety as a therapeutic option," said Alexa Kimball, MD, MPH, Associate Professor, Harvard Medical School, Department of Dermatology, Massachusetts General Hospital and lead study investigator. "STELARA continues to be an important option for dermatologists in the treatment of moderate to severe plaque psoriasis, and these findings are reassuring for physicians and their patients living with this chronic disease who might be candidates for biologic therapy."
In the PHOENIX 1 study, patients were randomized to receive placebo or STELARA 45 mg or 90 mg at weeks 0 and 4. Following assessment of PASI 75 at week 12, the primary endpoint, STELARA-treated patients continued to receive treatment every 12 weeks. At week 40, PASI 75 responders were re-randomized to receive maintenance therapy with STELARA or to withdraw from treatment and only receive retreatment with loss of response. More than two-thirds (n=517) of all STELARA-treated patients (n=753) in PHOENIX 1 continued to receive STELARA through the last scheduled five-year dose. Among the responders who continued treatment from week 40 through the end of the study, 48 and 59 percent had PASI 90 in the STELARA 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in an overall analysis of the study population, with 63 and 72 percent of all PHOENIX 1 participants achieving PASI 75, and 40 and 49 percent achieving PASI 90, of those individuals receiving STELARA 45 mg or 90 mg, respectively.
Adverse events were evaluated in more than 753 ustekinumab-treated patients with a total 3,104 patient-years (PY) of follow-up. Rates of AEs (221 and 209 per 100 PY), serious AEs (5.3 and 5.4 per 100 PY) and infections (84 and 82 per 100 PY) in the STELARA 45 mg and 90 mg treatment groups, respectively, remained stable over time. Rates of serious infection (1.03 per 100 PY), non-melanoma skin cancer (0.45 per 100 PY), malignancy other than non-melanoma skin cancer (0.48 per 100 PY), and major adverse cardiovascular events (0.35 per 100 PY) in combined STELARA groups were similarly consistent over the five-year period. No new safety signals were reported with the increased duration of exposure.
Source: prnewswire.com
"These data are important to the professional dermatology community as we now have five-year data—the longest continuous study evaluating a biologic in the treatment of psoriasis—that reinforce our understanding of STELARA efficacy and safety as a therapeutic option," said Alexa Kimball, MD, MPH, Associate Professor, Harvard Medical School, Department of Dermatology, Massachusetts General Hospital and lead study investigator. "STELARA continues to be an important option for dermatologists in the treatment of moderate to severe plaque psoriasis, and these findings are reassuring for physicians and their patients living with this chronic disease who might be candidates for biologic therapy."
In the PHOENIX 1 study, patients were randomized to receive placebo or STELARA 45 mg or 90 mg at weeks 0 and 4. Following assessment of PASI 75 at week 12, the primary endpoint, STELARA-treated patients continued to receive treatment every 12 weeks. At week 40, PASI 75 responders were re-randomized to receive maintenance therapy with STELARA or to withdraw from treatment and only receive retreatment with loss of response. More than two-thirds (n=517) of all STELARA-treated patients (n=753) in PHOENIX 1 continued to receive STELARA through the last scheduled five-year dose. Among the responders who continued treatment from week 40 through the end of the study, 48 and 59 percent had PASI 90 in the STELARA 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in an overall analysis of the study population, with 63 and 72 percent of all PHOENIX 1 participants achieving PASI 75, and 40 and 49 percent achieving PASI 90, of those individuals receiving STELARA 45 mg or 90 mg, respectively.
Adverse events were evaluated in more than 753 ustekinumab-treated patients with a total 3,104 patient-years (PY) of follow-up. Rates of AEs (221 and 209 per 100 PY), serious AEs (5.3 and 5.4 per 100 PY) and infections (84 and 82 per 100 PY) in the STELARA 45 mg and 90 mg treatment groups, respectively, remained stable over time. Rates of serious infection (1.03 per 100 PY), non-melanoma skin cancer (0.45 per 100 PY), malignancy other than non-melanoma skin cancer (0.48 per 100 PY), and major adverse cardiovascular events (0.35 per 100 PY) in combined STELARA groups were similarly consistent over the five-year period. No new safety signals were reported with the increased duration of exposure.
Source: prnewswire.com