New findings from the Psoriasis Longitudinal Assessment and registry (PSOLAR) show persistency difference among biologic therapies

Posted: 10 October 2014 | | No comments yet

Persistence of STELARA® (ustekinumab) significantly better than Anti-TNFs in treatment of Psoriasis according to observational study analysis…

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Janssen-Cilag International NV 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 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 STELARA®, infliximab, etanercept and adalimumab. 

“Finding a safe 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 Alan Menter, M.D., Chief, Division of Dermatology, Baylor University Medical Center, 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 STELARA, infliximab, adalimumab, etanercept and other conventional systemic agents.  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, and Cox proportional hazard regression (HR) analysis was used to compare time to stop/switch of STELARA with time to stop/switch of infliximab, adalimumab and etanercept.  Separate analyses were performed for first-line use (biologic-naïve patients; i.e., 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.

More patients overall were treated with STELARA (n=1,833) than with adalimumab (n=1,303), etanercept (n=537) or infliximab (n=327).  Among first-line use, significantly better persistence was observed for STELARA compared with other biologics (adalimumab vs. STELARA: HR 4.99; confidence interval (CI): 3.39-7.35; P < 0.0001; etanercept vs. STELARA: HR 5.59; CI: 3.77-8.29; P < 0.0001; infliximab vs. STELARA: HR 3.04; CI: 1.66-5.57; P = 0.0003).  Similar results were observed among the second- and third-line patient groups, with STELARA 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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