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.(1)
"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.(1)
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.(1)
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 (1)
Additional PSOLAR data presentations, including multiple safety analyses of the various treatment groups, are being presented at the EADV meeting.
The prospective, disease-based PSOLAR observational registry is a large, international study assessing patients with psoriasis who are receiving or are candidates for treatment with systemic therapies. The registry is a major component of the post-marketing safety monitoring commitment to regulatory agencies for ustekinumab and infliximab and is fully enrolled with 12,095 patients and a median duration of follow-up of 2.5 years. Patients are to be followed for eight years. Key demographics, disease characteristics and medication history were collected at enrollment. Adverse events and efficacy data are collected longitudinally. PSOLAR is funded and managed by Janssen. A PSOLAR global Steering Committee manages epidemiological research on psoriasis and its therapies.(2)
Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells. It affects 125 million people worldwide, including nearly 14 million Europeans.(3,4,5,6) Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques can crack and bleed, and may occur anywhere on the body.(7) The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world's population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.(3)
About STELARA(®) (ustekinumab)
Ustekinumab, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen plus UVA). Ustekinumab is also approved alone or in combination with MTX, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.(8)
Ustekinumab is not recommended for use in children and adolescents below the age of 18.(8)
In the treatment of psoriatic arthritis, the recommended dosing regimen for adults and the elderly (≥ 65 years) is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight > 100 kg.(8)
The safety data described below reflect exposure to ustekinumab in 7 controlled phase 2 and 3 studies of 4,031 patients with psoriasis and/or psoriatic arthritis, including 3,106 exposed for at least 6 months, 1,482 exposed for at least 4 years, and 838 exposed for at least five years.(8)
The most common adverse reactions (> 5%) in controlled periods of the psoriasis and psoriatic arthritis clinical studies with ustekinumab were nasopharyngitis, headache and upper respiratory tract infection. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for ustekinumab is serious hypersensitivity reactions including anaphylaxis.(8)
The Summary of Product Characteristics for ustekinumab, which includes safety information, can be found on https://www.medicines.org.uk/emc/.