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Janssen has reported new findings about Stelara at the annual meeting of the European Academy of Dermatology and Venereology (EADV)
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Janssen has reported new findings at the annual meeting of the European Academy of Dermatology and Venereology (EADV) showing significantly better persistency and lower rates of discontinuation with STELARA® (ustekinumab) therapy in comparison to anti-tumor necrosis factor (TNF)-alpha treatments among patients participating in the Psoriasis Longitudinal Assessment and Registry (PSOLAR), a post-marketing registry following patients with moderate to severe plaque psoriasis. The analysis reports on patients starting treatment, longevity of treatment and discontinuation rates of biologic therapies, including ustekinumab, infliximab, etanercept and adalimumab.
"Finding a therapy that patients can continue long term for a lifelong disease like psoriasis is important, especially when considering the potential consequences from stopping or switching treatment," said Dr Alan Menter, Chief, Division of Dermatology, Baylor University Medical Center, USA and lead investigator. "This particular analysis of the PSOLAR registry showed higher treatment longevity and lower rates of discontinuation with ustekinumab compared with anti-TNF-alpha agents."
PSOLAR is a longitudinal, observational study evaluating safety and clinical outcomes for patients with psoriasis who are treated with or are candidates for treatment with ustekinumab, infliximab, adalimumab, etanercept and other conventional systemic agents.2 PSOLAR is funded and managed by Janssen, and has a Steering Committee that includes external experts in the field of epidemiology and psoriasis. In this analysis, duration of treatment was defined by the length in days between the first dose of treatment and discontinuation of treatment; switch to a different treatment; registry withdrawal or the most recent data collection (August 23, 2013), whichever occurred first. Persistence was assessed by Kaplan-Meier (KM) analysis for time to therapy stop/switch. Cox proportional hazard regression (HR) analysis was used to compare time to stop/switch of ustekinumab with time to stop/switch of infliximab, adalimumab and etanercept.
Separate analyses were performed for first-line use (biologic-naive patients; ie first biologic started, with start occurring on registry), second-line use (second biologic started, with start occurring on registry) and third-line use (third biologic started, with start occurring on registry) to reduce confounding associated with prior exposures. It is important to note that patients are not randomised to treatments in PSOLAR, and interpretation of the results should take into account the characteristics of longitudinal registry studies.
More patients overall were treated with ustekinumab (n=1,833) than adalimumab (n=1,303), etanercept (n=537) or infliximab (n=327). Among first-line use, significantly better persistence was observed for ustekinumab compared with other biologics (adalimumab vs. ustekinumab: HR 4.99; confidence interval (CI): 3.39-7.35; P < 0.0001; etanercept vs. ustekinumab: HR 5.59; CI: 3.77-8.29; P < 0.0001; infliximab vs. ustekinumab: HR 3.04; CI: 1.66-5.57; P = 0.0003). Similar results were observed among the second- and third-line patient groups, with ustekinumab showing better treatment longevity and fewer discontinuations than other biologics. Reasons for stop/switch were similar across all four biologics. The analyses have not yet been adjusted for differences among treatment groups such as socioeconomic factors, setting of administration (self-administration versus in doctor's office) and geographic region.
Additional PSOLAR data presentations, including multiple safety analyses of the various treatment groups, are being presented at the EADV meeting.
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