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.
The researchers found that patients' out-of-pocket spending for topical steroids was $333.7 million. There was a 226.5% increase in total annual spending, from $237.6 million to $775.9 million.
The researchers found that the presence of psoriatic arthritis, weight, employment status, baseline disease severity all affect selection
The safety and efficacy of Humira in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis was evaluated in a Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study.
The researchers found that patients with psoriasis had 1.53 times greater risk of developing a malignancy versus patients without psoriasis (P<0.01).
Prediction of subsequent PsA was associated with baseline presence of arthralgia in women (hazard ratio [HR], 2.59), heel pain (HR, 4.18), high fatigue score (HR, 2.36), and high stiffness score (HR, 2.03).
A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.
Janssen announced new findings from VOYAGE 2 and NAVIGATE, two pivotal Phase 3 studies evaluating guselkumab for the treatment of moderate to severe plaque psoriasis.
Among randomized patients who entered the long-term extension trial period , 79.2% of patients receiving ustekinumab every 12 weeks and 87.1% of patients receiving ustekinumab every 8 weeks were in remission,
Climbazole enhances retinoid-associated biological activities in vivo and in vitro, according to a study published online January 19 in the International Journal of Cosmetic Science.
Perrigo announced that the Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for Desoximetasone Topical Spray, 0.25%, the first generic of Taro's Topicort Spray, 0.25%.
Childhood psoriasis impacts parents' quality of life in multiple domains, especially their emotional well-being, according to a study published in the February issue of the Journal of the American Academy of Dermatology.