Elinzanetant (Lynkuet®), an oral selective dual neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptor antagonist, is an important non-hormonal treatment option for moderate to severe vasomotor symptoms (VMS) associated with menopause. It is the first dual NK-targeted therapy approved for this indication in several countries, including the USA and in the EU. In pivotal phase 3 trials, elinzanetant significantly reduced the frequency and severity of menopausal VMS (primary endpoints), with reductions in frequency evident as early as week 1. Elinzanetant also significantly improved sleep disturbances and menopause-related quality of life. Efficacy was sustained for up to 52 weeks of treatment. Elinzanetant was generally well tolerated, with fatigue and headache being the most frequent treatment-related adverse events. The drug showed a favourable safety profile, with no hepatotoxicity signal. Vasomotor symptoms (VMS), otherwise known as hot flashes, are cardinal symptoms of menopause. VMS can be frequent, severe and disruptive, affecting sleep and quality of life for many women. Elinzanetant (Lynkuet®) is the first oral treatment that blocks neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptors in the brain, which are involved in triggering hot flashes. Elinzanetant has been approved for the treatment of moderate to severe menopausal VMS in several countries including the USA and in the EU. Clinical trials have shown that elinzanetant significantly reduces the frequency and severity of VMS, and improves sleep disturbances and menopause-related quality of life. Elinzanetant was generally well tolerated, with no evidence of liver toxicity. The most frequent treatment-related adverse events included fatigue and headache. Thus, elinzanetant is an important non-hormonal treatment option for moderate to severe menopausal VMS.
Non‑steroidal anti‑inflammatory drugs (NSAIDs) are a common cause of drug‑induced hypersensitivity manifesting as urticaria and/or angioedema. These reactions arise via two principal mechanisms with distinct clinical implications: selective IgE‑mediated allergy to a single NSAID, and cross‑reactive intolerance driven by cyclooxygenase‑1 (COX‑1) inhibition. This review synthesizes current evidence on mechanisms, phenotypes, diagnosis, and management, emphasizing phenotype‑based clinical reasoning. We outline the European Network for Drug Allergy /European Academy of Allergy and Clinical Immunology classification system, highlight atypical and blended presentations, and stress the central role of carefully taken history combined with graded oral challenge testing where safe, given the poor performance of most skin and in-vitro assays outside pyrazolone allergy. For management, we summarize avoidance strategies, choice of safe alternatives (particularly COX‑2, selective agents), indications and protocols for aspirin desensitization, and the role of comorbidity control and adjuncts such as leukotriene receptor antagonists and biologics in selected cases. A pragmatic algorithm is provided to guide classification, testing, and therapy. Consistent application of these principles minimizes unnecessary blanket NSAID avoidance while preserving analgesic and anti‑inflammatory options for patients.
Vunakizumab (安达静®), a novel anti-IL-17A humanised IgG1/k monoclonal antibody, is a new and efficacious treatment option for patients with moderate-to-severe chronic plaque psoriasis. It has been approved in China in this indication in adults who are candidates for systemic therapy or phototherapy. In a pivotal phase 3 trial, vunakizumab significantly increased the proportions of patients who achieved reductions in the extent and severity of psoriasis, and complete or near complete clearance of psoriasis at week 12 of treatment compared with placebo. Additionally, vunakizumab improved quality of life compared with placebo. Complete or near complete clearance of symptoms and lesions was maintained in the majority of patients through to week 52. Vunakizumab was generally well tolerated through the 12-week induction therapy period. No new safety signals were reported in the maintenance therapy period through to week 52. Chronic plaque psoriasis is an inflammatory skin condition that can cause a substantial reduction in a patient’s quality of life. Vunakizumab (安达静®) is a new treatment that blocks one of the key inflammatory cascades that leads to chronic plaque psoriasis. It is approved in China for adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. In a pivotal phase 3 study, complete or near complete clearance of chronic plaque psoriasis symptoms and lesions occurred significantly more frequently in vunakizumab than placebo recipients at week 12 of treatment, and treatment response was maintained in the majority of vunakizumab recipients through to week 52. Vunakizumab was also generally well tolerated through to week 52. Therefore, vunakizumab represents a new and efficacious treatment option for patients with moderate-to-severe chronic plaque psoriasis.
Clesrovimab (ENFLONSIATM, clesrovimab-cfor), a long-acting monoclonal antibody that targets the respiratory syncytial virus (RSV) fusion protein, is a useful addition to prophylactic options for RSV-associated lower respiratory tract (LRT) disease in neonates and infants born during or entering their first RSV season. As demonstrated in the phase 2b/3 CLEVER clinical trial, a single 105 mg dose of clesrovimab, irrespective of body weight, provides durable protection against RSV-associated medically-attended lower respiratory infection (RSV-MALRI), and reduces RSV-associated hospitalizations in neonates and infants born during or entering their first RSV season. Pharmacokinetic data from the phase 3 SMART trial supports the efficacy of clesrovimab in infants and children at increased risk of severe RSV disease. Clesrovimab was generally well tolerated, with low reactogenicity, and had a similar adverse event profile to placebo (CLEVER) and palivizumab (SMART). Respiratory syncytial virus (RSV) is a significant cause of infant hospitalizations and deaths. Clesrovimab (ENFLONSIATM), a novel long-acting monoclonal antibody (mAb) that binds a highly conserved site on the RSV fusion protein, was recently approved in the USA and the EU for the prevention of RSV-associated lower respiratory tract (LRT) disease in neonates and infants born during or entering their first RSV season. As demonstrated in clinical trials, clesrovimab, administered as a single 105 mg dose regardless of body weight, provides durable protection against RSV disease in neonates and infants born during or entering their first RSV season. Data from a phase 3 clinical trial supports the efficacy of clesrovimab in infants and children aged < 2 years at increased risk of severe RSV disease. Clesrovimab is well tolerated, with low rates of adverse events. As the second long-acting mAb approved for prevention of RSV disease, clesrovimab represents a useful addition to treatment options for neonates and infants born during or entering their first RSV season.
Fungal pathogens can cause serious disease in neonates, with Candida species being the most common cause of fungal infections. As with adults, the choice of antifungal agents used for treatment should depend on the susceptibility of the pathogen. Although, in neonates at high risk of invasive fungal infections, empiric antifungal treatment at initial signs of infection and antifungal prophylaxis should be considered. Careful dose adjustments may be required to achieve effective and safe drug concentrations for antifungal agents in neonates, due to differences in drug clearance and distribution when compared with adults.
Chronic kidney disease (CKD) is a progressive condition that increases the risk of cardiovascular disease, end-stage kidney disease and premature death. Its prevalence is heightened among older adults, largely because major causes of CKD, including diabetes and hypertension, are common in this population. Preventing CKD and its complications in older adults involves a three-step approach. The first step focuses on modifying risk factors and managing comorbidities to help prevent the onset of CKD. The second emphasises regular screening and monitoring to support the early identification. The third involves initiating timely treatment once CKD is diagnosed to slow disease progression and manage associated complications. Together, these measures aim to enhance quality of life and help preserve functional status in older adults.
Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are approved in the USA for indications including glycemic control in persons with type 2 diabetes (T2D) and weight reduction in persons with obesity/overweight. We conducted a subject-level analysis of clinical trials to evaluate a potential drug effect of GLP-1 RA on suicidal ideation and behavior (SI/B) and other psychiatric endpoints upon learning of postmarketing reports of SI/B in patients taking GLP-1RA. We included prospective, randomized, placebo-controlled trials of GLP-1 RAs approved from 2005 to 2023 that evaluated glycemic control, weight reduction, or cardiovascular risk in persons with T2D or obesity/overweight. The primary outcome was the first occurrence of SI/B retrospectively identified by the Standard Medical Dictionary for Regulatory Activities Query and classified using the Columbia Classification Algorithm of Suicide Assessment from subject-level data. Other endpoints were identified using adverse event queries. Mantel–Haenszel methods stratified by trial were used to estimate the rate ratio (RR) and rate difference (RD) comparing GLP-1 RA to placebo. Of the 91 placebo-controlled trials (N = 107,910; 271,000 person-years), 62 evaluated persons with T2D; 29 evaluated persons with obesity or overweight. The GLP-1 RA arm had 55 SI/B events during 14.3 × 104 PY, corresponding to an incidence rate of 3.6 SI/B events/104 PY. The placebo arm had 44 SI/B events during 12.8 × 104 PY, corresponding to an incidence rate of 3.6 SI/B events/104 PY. The RR for SI/B comparing GLP-1 RA to placebo was 1.0 (95
Statins are a cornerstone of secondary prevention following acute ischemic stroke (AIS). Widely used for their lipid-lowering effects, emerging evidence suggests the pleiotropic properties of statins provide a benefit in AIS management, including for patients with low baseline lipid levels. Established guidelines for statin therapy following AIS are inconsistent. Treatment optimization requires a personalised approach which considers stroke subtype and patient characteristics. Emerging strategies in statin care following AIS include novel drug-delivery systems improving bioavailability to the brain and combination therapies for patients with comorbid conditions or resistance to statin therapy.
Multiple high-cost dermatologic drugs may lose patent protection and/or market exclusivity between 2027 and 2037. While the resulting introduction of generics and biosimilars has the potential to improve affordability and expand patient access, real-world uptake remains variable and is shaped by complex regulatory, payer, and market dynamics. This review synthesizes current clinical, regulatory, and health policy literature to examine U.S. factors influencing generic and biosimilar adoption in dermatology and to contextualize these challenges within the upcoming patent cliff. Generics often capture substantial market share shortly after FDA approval, whereas biosimilars face barriers due to distinct approval pathways and substitution policies, among other factors. Additional obstacles—such as formulary exclusions, patent evergreening, prior authorizations, and step therapy—further delay patient access, increase clinician burden, and worsen outcomes. Patient and provider hesitancy regarding safety, efficacy, and interchangeability further constrains uptake. As dermatology approaches a period of significant therapeutic transition, proactive clinician engagement, regulatory alignment, and targeted education will be essential to translate upcoming patent/exclusivity expirations into durable improvements in access, affordability, and quality of care.
Anticoagulant treatments are used to reduce the risk of stroke in patients with atrial fibrillation (AF) though they are associated with increased risk of bleeding. In most patients with AF, including those who are fit and older, direct oral anticoagulants (DOACs) are likely to have greater treatment benefits than warfarin, a vitamin K antagonist. However, patients with AF who also have advanced age, frailty, increased risk of falling, chronic kidney disease or a history of bleeding are amongst those at higher risk of major bleeding or drug overexposure. Current data suggest that DOACs may retain their treatment benefits in these patient subgroups, although recent guidelines on the management of AF emphasise the importance of taking an individualised, whole person treatment approach when choosing an anticoagulant treatment.
Attention-deficit hyperactivity disorder (ADHD) co-occurring with substance use disorder (SUD) is highly prevalent and is associated with poor prognosis and negative treatment outcomes. Comprehensive management of ADHD-SUD comorbidity involves pharmacotherapy integrated with psychotherapy to enhance treatment retention and success. Psychostimulants are the mainstay of ADHD pharmacotherapy and do not exacerbate SUD symptoms; however, psychostimulants are associated with an inherent risk of misuse, abuse and diversion. Cognitive behavioural therapy is a first-line behavioural intervention that teaches patients harm reduction and coping skills while addressing affective and environmental risks for substance use.
Stapokibart (Kangyueda®; 康悦达®) is a humanised immunoglobulin (Ig) G4 monoclonal antibody that targets the interleukin (IL)-4 receptor alpha (IL-4Rα) subunit, a shared receptor for IL-4 and IL-13, which are key drivers of type 2 inflammation. It expands the treatment options for adults in China with type 2 inflammatory diseases, specifically moderate-to-severe atopic dermatitis, chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate-to-severe seasonal allergic rhinitis, whose symptoms are inadequately controlled despite standard of care. Stapokibart is injected subcutaneously every 2 weeks. It is the second anti-IL-4Rα monoclonal antibody approved in China after dupilumab. Randomised, double-blind, placebo-controlled, phase 3 trials conducted in adults in China demonstrate that stapokibart significantly improves the signs and symptoms of moderate-to-severe atopic dermatitis, reduces nasal polyp size and congestion in severe CRSwNP and improves daily nasal symptoms in moderate-to-severe seasonal allergic rhinitis. Across all indications, stapokibart improves quality of life and is generally well tolerated, with a low incidence of conjunctivitis and mostly mild-to-moderate adverse events. Infection-related adverse events, including upper respiratory tract infections, were common across all indications. Efficacy and tolerability were sustained up to 52 weeks in patients with moderate-to-severe atopic dermatitis and severe CRSwNP. Type 2 inflammatory diseases arise when the immune response responsible for protecting the body against parasitic pathogens, venoms and toxins becomes overactive. This dysregulation leads to the characteristic immune response seen in type 2 inflammatory diseases such as atopic dermatitis, CRSwNP, allergic rhinitis and asthma. IL-4 and IL-13 are key cytokines that drive type 2 inflammation. They share a common receptor subunit, IL-4Rα. Stapokibart is a humanised IgG4 monoclonal antibody that blocks IL-4 and IL-13 signalling by targeting IL-4Rα. In clinical trials in adults, subcutaneous stapokibart significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis, reduced nasal polyp size and congestion in severe CRSwNP and improved daily nasal symptoms in moderate-to-severe seasonal allergic rhinitis. Stapokibart is generally well tolerated and associated with a low incidence of conjunctivitis. Stapokibart expands the treatment options for adults in China with moderate-to-severe atopic dermatitis, CRSwNP and moderate-to-severe seasonal allergic rhinitis whose symptoms are inadequately controlled despite standard of care.
Alopecia areata (AA) is an autoimmune disorder characterized by episodes of non-scarring hair loss. AA has an unpredictable disease course and can have a substantial negative impact on health-related quality of life (HRQOL) and mental well-being. This Adis Summary of Research reports the effects of baricitinib on measures of HRQOL and symptoms of anxiety and depression in patients with severe AA who achieved sustained scalp regrowth while receiving continuous treatment with baricitinib.
It is uncertain whether the relative increase in cardiovascular risk associated with non-steroidal anti-inflammatory drug (NSAID) use differs according to hypertension status. The aim of this study was to investigate the association between NSAID use and major adverse cardiovascular events (MACE) in individuals with never, former, and current hypertension. We conducted a case-crossover study including all first-time respondents to the Danish National Health Surveys of 2010, 2013, or 2017, without prior cardiovascular disease, who experienced a MACE from survey completion through 2021. We defined MACE as a composite of myocardial infarction, ischemic stroke, heart failure, atrial fibrillation or flutter, and cardiovascular death. We used conditional logistic regression to estimate odds ratios (ORs) and 95
Gabapentin is a newer-generation antiseizure medication (ASM) that is Food and Drug Administration (FDA)-approved for the treatment of postherpetic neuralgia and partial seizures. In addition, it is also widely prescribed off-label for other pain conditions, migraine prophylaxis, and psychiatric disorders. However, there is currently limited safety data for the use of gabapentin in pregnancy. Understanding how gabapentin use in pregnancy has changed over time will facilitate future safety studies. Here, we examine the trends of gabapentin utilization, prescribing patterns, and indications in pregnant people in Manitoba, Canada over a 20-year period. A population-based cohort study was conducted using administrative health databases in Manitoba, from 1 April 1999 to 31 March 2019. Our data cohort captured all pregnant people living in Manitoba between 1999 and 2019. Pregnancy capture is based on administrative data identifying all pregnancies, including live births, stillbirths, miscarriages, and terminations. Inclusion criteria encompassed all pregnancies in Manitoba between 1999 and 2019 that met data completeness criteria; exclusion criteria were missing gestational age data or invalid records. Gabapentin use was defined as having at least one gabapentin prescription filled during the exposure period. The trends of utilization and indications for gabapentin prescriptions were examined in each pregnancy trimester as well as over the whole pregnancy term. Descriptive statistics were used to assess gabapentin prescriptions by prescriber specialty. The main outcome is gabapentin prescription fills during pregnancy. There were 0.30
Fenugreek (Trigonella foenum-graecum) seeds are widely used for their hypoglycemic properties, which are attributed to bioactive compounds that enhance insulin secretion and sensitivity and reduce hepatic glucose production. While these effects may complement conventional antidiabetic therapies, concomitant use may increase the risk of severe hypoglycemia. This paper investigates incidents of hypoglycemic coma linked to the concurrent use of fenugreek seeds and premixed insulin, based on four case reports from an ethnobotanical study of diabetic patients. An ethnobotanical survey was conducted in several healthcare facilities in the Rabat–Salé–Kénitra region of Morocco among diabetic patients reporting fenugreek use. Data regarding the form, mode of administration, dose of fenugreek, and its concomitant use with antidiabetic medications were collected using a semi-structured questionnaire. Plant samples were botanically authenticated, and the causality between fenugreek intake and hypoglycemic events was assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) standardized causality assessment method. All participants provided informed consent. Four patients receiving insulin therapy developed hypoglycemic coma while concomitantly consuming fenugreek seeds in various traditional forms and doses. The temporal relationship and clinical evolution supported a possible-to-probable causal association, consistent with synergistic glucose-lowering mechanisms, including potentiation of insulin activity, delayed intestinal glucose absorption, and enhanced insulin signaling. To the best of available knowledge, this is the first report documenting such an interaction. These findings highlight that the concomitant use of fenugreek and insulin may precipitate life-threatening hypoglycemia. Healthcare professionals should actively inquire about medicinal plant use, closely monitor glycemic control, and counsel patients regarding potential herb–drug interactions. Strengthened pharmacovigilance, phytovigilance, and patient education are essential to ensure the safe integration of medicinal plants into diabetes management. This work provides clinically relevant evidence supporting safer integrative practices in diabetes care across diverse healthcare settings worldwide today.
Lower urinary tract symptoms (LUTS; i.e. storage, voiding and post-micturition symptoms) are a frequent complaint in adult men and strongly associated with aging. A common cause is benign prostatic obstruction, which typically results from benign prostatic hyperplasia (BPH) progressing through benign prostatic enlargement. Treatment of BPH-associated LUTS can be conservative, pharmacological or surgical, and aims to reduce the obstruction and alleviate LUTS. A personalized approach (considering, among other factors, symptom severity, prostate size, comorbidities and patient preference) is recommended. In patients with mixed symptom profiles or those who have insufficiently responded to pharmacological monotherapy, the use of pharmacological combination therapy (e.g. α1-adrenoceptor antagonist plus 5-alpha reductase inhibitor) may be warranted. Tolerability data for most pharmacological combination therapies are limited.
Myasthenia gravis (MG) is a rare acquired autoimmune disease affecting the neuromuscular junction, characterized by fluctuating muscle weakness that worsens with activity and improves with rest. The disease predominantly affects ocular, bulbar, neck, and limb muscles, with a prevalence of 1/5000 and incidence of 1/250,000–1/33,000 in Europe. Pathogenesis involves autoantibodies targeting post-synaptic membrane antigens, primarily acetylcholine receptors (AChR-Ab+, 80–90
Rising obesity rates in the US highlight the growing need for effective weight-management options. Glucagon-like peptide-1 (GLP-1) agonists, originally developed for type 2 diabetes mellitus, have become increasingly popular for weight management due to their appetite-reducing and satiety-enhancing effects. To evaluate self-reported effectiveness, perceptions of safety, and barriers associated with GLP-1 agonists among US adults. An online survey was distributed via Prolific in May 2024. A total of 1955 usable observations were categorized into four groups: Currently Taking (n = 495), Previously Taken (n = 468), Planning to Take (n = 492), and Neither Taken nor Planning (n = 500). Interval, binary logistic, and ordered probit models were estimated. In the Currently Taking group, self-reported weight loss averaged 16.44 lb at ≤ 6 months, 29.83 lb at 6–12 months, and 36.09 lb at > 1 year; in the Previously Taken group, the corresponding means were 14.93 lb, 24.70 lb, and 31.81 lb. Financial constraints, side effects (notably nausea and gastrointestinal issues), and insufficient insurance coverage were the most commonly reported barriers. Respondents generally perceived GLP-1 agonists as safe for short- and long-term use, with stronger positive perceptions among those with higher education and greater self-reported knowledge of the medications. These self-reported patient experiences suggest that improving affordability and insurance coverage of GLP-1 agonists could support more effective real-world weight management, while reinforcing the need for longitudinal clinical research.
BP14 refers to a recently approved biosimilar of the reference product Neulasta®. This study was conducted to assess the pharmacokinetic and pharmacodynamic similarity between BP14 and Neulasta®. This randomized, double-blind, two-period crossover study was conducted in healthy male participants. Each participant received a single dose of 6 mg on day 1 on each treatment period and followed up for pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity assessments. Primary PK endpoints were Cmax and AUC0–t while absolute neutrophil count (ANC) AUC0–t and ANC Emax were PD endpoints. The total study duration was approximately 16 weeks including 4 weeks of screening period. A total of 184 participants were randomized, with 92 participants in each treatment sequence. Baseline characteristics were well balanced between two groups. For primary PK endpoints, the ratio of geometric means (GMR; 90
