The Phase 3 study (N=318) enrolled patients aged 18 to 78 years with moderate-to-severe chronic plaque psoriasis who had not previously received treatment with ≥1 biologic.
To investigate the effectiveness of CAM modalities in the treatment of plaque psoriasis, researchers searched several databases to identify studies where CAM was used as an intervention.
Its long-term safety was evaluated in a phase 3, multicenter, open-label study of 555 adults with moderate to severe plaque psoriasis.
"If these findings are confirmed, adherence to a Mediterranean diet should be integrated into the routine management of moderate to severe psoriasis," the authors write.
The expanded approval was supported by findings from a Phase 3 clinical program (CIMPASI-1, CIMPASI-2, and CIMPACT), which enrolled ~1000 patients who were biologic-naive or biologic-experienced.
The drug also maintained results at 48 weeks for patients who were re-randomized to placebo or continued with certolizumab. Reported adverse events were similar to those previously reported with the anti-tumor necrosis factor class.
The approval was based on data from a randomized, placebo-controlled trial that included 149 adults with plaque psoriasis who had a minimum body surface area (BSA) involvement of 1%, a static Physician Global Assessment (sPGA) score of ≥3 (moderate psoriasis), a sPGA of Genitalia score of ≥3 (moderate psoriasis involving the genital area), who failed to respond to or were intolerant of at least one topical therapy used for the treatment of psoriasis affecting the genital area, and who were candidates for phototherapy and/or systemic therapy.
Based on the Pittsburgh Sleep Quality Index, 53.9% of patients with psoriasis were poor sleepers versus 21.9% of controls. Itch symptoms were significantly associated with all sleep-related outcomes.
The authors examined data from 8887 individuals who began TNF antagonist treatment for an autoimmune disease from 2001 through 2010 and were followed through 2012; 52% of these patients were screened for HBV before treatment.
The FDA approval was supported by data from 2 double-blind, randomized, vehicle-controlled trials (N=532) in patients with moderate to severe plaque psoriasis (IGA 3 or 4 and BSA ≥3%).
The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients.
The researchers found that at week 4, more patients in the intervention group were adherent to Cal/BD cutaneous foam versus patients in the non-intervention group (65 versus 38%: P=.004).
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.