The FDA approval of Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development program.
Both Calm topical and Calm + Detox supplements do not contain any steroids, parabens, sulfates, preservatives, petroleum, tree nuts, and gluten.
Jemdel, if approved, will be the first high-potency topical steroid for plaque psoriasis with dosing for 8 weeks. The most common adverse event in clinical trials of Jemdel was upper respiratory tract infection.
The dose of topical agents and frequency of phototherapy were reduced and the Psoriasis Area and Severity Index score decreased to 2.0.
The researchers found that compared to children without psoriasis, those with psoriasis were more likely to develop comorbidities.
Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.
At 16 weeks, 73% of risankizumab patients achieved PSAI 90 vs. 2% of the placebo patients and sPGA 0/1 was reached by 84% of riskanizumab patients vs. 7% of placebo patients (P<0.001).
To determine the risk of T2DM, researchers compared adults with psoriasis (n=8124), grouping them by affected BSA, to those without psoriasis (n=76,599); patients were followed for ~4 years.
In the other Phase 3 trial, transitioning to guselkumab treatment was more effective than continued ustekinumab use in reducing IGA scores in those minimally responsive to ustekinmab.
The study quantifies the importance of clinical attributes of psoriasis therapies that dermatologists and psoriasis patients consider when choosing treatments.
The researchers compared an cohort of patients with psoriasis (≥18 years of age) drawn from several databases to 20 patients without psoriasis who were matched by age, sex, and general practice (n=55,537 and 854,314 respectively).
Methotrexate was the most commonly used agent (270 patients [69.2%]), followed by biologic agents, primarily etanercept (106 [27.2%]), acitretin (57 [14.6%]), cyclosporine (30 [7.7%]), and fumaric acid esters by (19 [4.9%]). Seventy-three patients (18.7%) used ≥1 medication.
The expanded approval was supported by data from a Phase 3 study that evaluated the safety and efficacy of subcutaneous Stelara in adolescents aged ≥12 years.
Patients who were crossed over to Tremfya from Humira showed substantial improvement in PSSD scores from Week 48 to Week 100.
Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.
Researchers will compare the pharmacokinetics and clinical outcomes between patients continuously receiving Humira vs. repeatedly switching between Humira and BI 695501.
Infliximab products work by neutralizing the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibiting the binding of TNF-alpha with its receptors.
In the NAVIGATE study, 31% of patients treated with Tremfya were considered cleared or almost cleared vs. 14% of patients treated with Stelara (ustekinumab; Janssen Biotech) at Week 28.
A clinical trial (Pfaff S et al. 2015) of 47 individuals with mild psoriasis found significant improvement in change from baseline of Local Psoriasis Severity Index in patients receiving UV-free blue light home treatment.
The researchers found that significantly more patients receiving tofacitinib 5mg and tofacitinib 10mg versus placebo achieved a ≥50% reduction in the Nail Psoriasis Severity Index (NAPSI) score from baseline (NAPSI50)
Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA.