The European Commission has approved ritlecitinib to treat adults and adolescents 12 years of age and older with severe alopecia areata. Ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. According to results from ALLEGRO-LT phase 3 trial, the most common adverse reactions included diarrhea (9.2%), acne (6.2%), URTI (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%).
The oral Janus kinase 1 inhibitor abrocitinib has been approved in Europe for the treatment of moderate to severe atopic dermatitis (AD) in adults, who are candidates for systemic therapy. Approval by the European Commission was based on the results of studies that include four phase 3 clinical trials (JADE MONO-1, JADE-MONO-2, JADE COMPARE, JADE REGIMEN) and an ongoing open-label extension study (JADE EXTEND) in over 2,800 patients.
Source: Mdedge
ON101 (Fespixon, Oneness Biotech), a first-in-class, macrophage-regulating, wound-healing cream for diabetic foot ulcers has shown benefit over absorbent dressings in a phase 3 trial, with another trial ongoing. The published trial showed that foot ulcers treated with ON101 cream were almost three times more likely to be completely healed at 16 weeks than those treated with standard care with an absorbent dressing (Aquacel Hydrofiber, ConvaTec) (odds ratio, 2.84; P < .001).
Source: Medscape
Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F.
Dose: 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks.
Adverse effects: Upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.
Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance.
Source: MDedge
Five recently approved acute migraine treatments were specifically noted: two small-molecule calcitonin gene-related peptide (CGRP) receptor antagonists — rimegepant and ubrogepant — along with the nonsteroidal anti-inflammatory drug celecoxib, the serotonin 5-HT1F agonist lasmiditan, and remote electrical neuromodulation (REN). Highlighted risks include serious cardiovascular thrombotic events in patients on celecoxib, along with driving impairment, sleepiness, and the possibility of overuse in patients on lasmiditan.
Regarding acute treatment overall, the statement recommended NSAIDs, nonopioid analgesics, acetaminophen, or caffeinated analgesic combinations — such as aspirin plus acetaminophen plus caffeine — for mild to moderate attacks. For moderate or severe attacks, they recommended migraine-specific agents such as triptans, small-molecule CGRP receptor antagonists (gepants), or selective serotonin 5-HT1F receptor agonists (ditans).
Source: Medscape
Toripalimab is a monoclonal antibody that blocks programmed cell death protein 1 (PD-1), developed in China and recently approved there for the third-line treatment of NPC, among other indications. The US FDA has granted it a breakthrough therapy designation for recurrent/metastatic NPC, as well as fast-track and orphan drug status for other tumor types.
Source: Medscape
The greatest relative benefit from omecamtiv mecarbil, a novel myotropic drug class that improves cardiac performance, is produced in heart failure patients with the lowest left ventricular ejection fraction (LVEF), a new analysis of the recently published phase 3 GALACTIC-HF trial has found.
The phase 3 multinational GALACTIC-HF trial, published earlier this year, linked omecamtiv mecarbil with an 8% reduction in the risk of a heart failure-related events or cardiovascular death, relative to placebo, which was the primary outcome. For entry, HFrEF patients were required to have a LVEF of 35% or less.
Source: Medscape
Inhibition of interleukin (IL)-6 with ziltivekimab reduces multiple biomarkers of inflammation and thrombosis in patients at high atherosclerotic risk with moderate to severe chronic kidney disease (CKD) and elevated C-reactive protein, results of the phase 2 RESCUE trial show.
At 12 weeks, median levels of high-sensitivity C-reactive protein (hsCRP) were reduced by 77%, 88%, and 92% with 7.5 mg, 15 mg, and 30 mg doses of ziltivekimab, respectively, every 4 weeks, compared with a 4% reduction with placebo.
Source: Medscape
Three reasons why consider torsemide should be considered a first-line treatment for heart failure.
In a trial published in 2001, researchers randomized 234 patients with heart failure to receive torsemide or furosemide for 1 year. The percentage of patients who had one or more hospital readmissions was lower among those who received torsemide, compared with those who received furosemide in the torsemide group for heart failure (17% vs. 32%, respectively; P < .01) and for other cardiovascular causes (44% vs. 59%; P = .03). In addition, the number of total admissions was numerically lower for patients in the torsemide group, compared with the furosemide group for heart failure (23 vs. 61; P < .01) and for cardiovascular causes (78 vs. 130; P = .02).
In a separate study, researchers conducted an open-label trial of 237 patients with New York Heart Association (NYHA) class II-IV heart failure who were randomized to torsemide or furosemide. They found that a significantly higher percentage of patients in the torsemide group improved by one or more NYHA heart failure class, compared with those in the furosemide group (40%; P = .001 vs. 31%; P = .3). Moreover, patients treated with furosemide had more restrictions of daily life at 9 months, compared with those treated with torsemide (P < .001).
A separate, open-label, nonrandomized, postmarketing surveillance trial also found benefits of torsemide over furosemide or other agents used for patients with NYHA class III and IV heart failure. Patients treated with torsemide had a lower total mortality, compared with those treated with furosemide or other agents (2.2% vs. 4.5%, respectively; P < .05) as well as a lower cardiac mortality (1.4% vs. 3.5%; P < .05). They were also more likely to improve by one or more heart failure class (46% vs. 37%; P < .01) and less likely to have potassium levels less than 3.5 mEq/L or greater than 5.0 mEq/L (13% vs. 18%; P = .01).
Source: Medscape
European Medicines Agency (EMA) issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are eligible for systemic therapy.
Tralokinumab would become the first approved fully human monoclonal antibody targeting the IL-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with inflammatory skin disease.
The US Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate-to-severe AD in adults. Data from the pivotal ECZTRA 1, 2 and ECZTRA 3 phase 3 studies were also submitted to the FDA alongside the BLA.
Source: Medscape
