Drugs in Context最新文献

Background: Palmoplantar pustulosis (PPP) is a chronic, relapsing skin condition characterized by sterile, pruritic pustules on erythematous, thickened skin of the palms and soles. It often causes painful fissures, leading to functional impairment and reduced quality of life. Due to its limited response to conventional therapies and biologic therapies, PPP remains a therapeutic challenge. Recent findings implicate both T helper 17 (T_H17)-mediated and T_H2-mediated inflammation, prompting interest in broader immunomodulatory treatments such as Janus kinase (JAK) inhibitors.

Methods: This narrative review evaluates current evidence on the efficacy and safety of JAK inhibitors in the treatment of PPP. Published studies involving tofacitinib, upadacitinib and baricitinib were identified and reviewed.

Results: Clinical improvements with JAK inhibitors have been reported, particularly in cases refractory to conventional systemic therapy. Findings include reductions in the Palmoplantar Pustulosis Area and Severity Index (PPPASI) and improvements in patient-reported quality of life, with a low incidence of adverse effects. An ongoing trial investigating deucravacitinib reflects growing interest in this drug class.

Conclusion: JAK inhibitors show promise as a novel therapeutic option for PPP, given their ability to modulate multiple inflammatory pathways. Although current evidence is limited to case series and reports, results are encouraging and warrant confirmation through well-designed clinical trials.

Myasthenia gravis (MG) mostly affects women of childbearing age. Since the disease course may be affected during pregnancy and postpartum, monitoring and appropriate treatment of MG in pregnant women are crucial. Current treatment options for pregnant women with refractory MG are limited by possible teratogenicity and inadequate lactation data. This case report describes a successful pregnancy in a patient who received eculizumab for refractory generalized MG that was difficult to manage during the pre-pregnancy period. We also report the experience of preterm labour and neonatal MG and the 1-year follow-up of the neonate. Considering the risk-benefit balance, eculizumab can be recommended during pregnancy and postpartum, especially in women with refractory generalized MG.

Background: Reducing the microbial load in the upper respiratory tract can reduce the risk of transmission and spread of respiratory tract infections.

Methods: The in vitro antimicrobial activity of a new oral spray combining 0.15% benzydamine hydrochloride and 0.5% cetylpyridinium chloride (Tantum Verde DUO^®, Angelini Pharma S.p.A., spray duo) was investigated.

Results: Spray duo showed bacterial, yeasticidal and virucidal activity against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus hirae (1 minute contact), Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes (30 second contact), Candida albicans (5 minute contact), modified vaccinia Ankara (3 minute contact), influenza A virus subtype H1N1, herpes simplex virus 1, and SARS-CoV-2 (1 minute contact).

Conclusions: Spray duo showed antimicrobial activity under in vitro conditions. Further investigations are warranted to evaluate the antimicrobial activity in clinical practice.

We report the case of an 18-year-old woman with early-onset severe allergic asthma and no other type 2 biomarkers except the presence of IgE, complicated by persistent airflow limitation, air trapping and forced oscillation technique-defined small airway dysfunction, who achieved significant clinical improvement with first-line tezepelumab (TZP) therapy. Initial treatments, including high-dose extrafine-inhaler triple therapy with a beclomethasone-formoterol-glycopyrronium combination, failed to improve asthma control and lung function. Given the discordance between allergic phenotype and treatable traits, such as persistent airflow limitation and small airway dysfunction, TZP, a thymic stromal lymphopoietin inhibitor with broad anti-inflammatory effects, was initiated instead of omalizumab. After 6 months of treatment, the patient showed marked clinical and functional improvement: Asthma Control Test score increased from 12 to 22, forced expiratory volume in 1 second rose from 67% to 95%, residual volume normalized, and forced oscillation technique parameters improved substantially. This case illustrates how the identification of specific treatable traits can guide personalized biologic therapy, even when conventional phenotype-driven algorithms suggest otherwise. In patients with early-onset allergic asthma and atypical functional profiles, TZP may offer a superior therapeutic option by targeting upstream airway inflammation and reversing small airway dysfunction. Our findings support a precision medicine approach in severe asthma, emphasizing multidimensional assessment and biomarker-guided biologic selection.

Background: Hip osteoarthritis (OA) is a leading cause of disability in older adults, yet long-term, non-surgical treatment options remain limited. Viscosupplementation with intra-articular hyaluronic acid has shown promise, but evidence for its sustained efficacy in hip OA is scarce. This study evaluates the 10-year efficacy and safety of repeated ultrasound (US)-guided injections of HyalOne^®/Hyalubrix^® 60 in patients with symptomatic hip OA.

Methods: A retrospective, observational, open-label study was conducted on 681 patients with symptomatic hip OA treated with HyalOne^® between 2010 and 2013, with follow-up through 2023. Patients received one US-guided intra-articular injection every 6 months, with additional injections as needed. Pain and functional outcomes were assessed using the Visual Analogue Scale and the Lequesne Index. Non-steroidal anti-inflammatory drug (NSAID) consumption and adverse events were also monitored.

Results: Overall, 481 patients completed the 10-year follow-up. Pain reduction was observed across all age and body mass index groups, with the highest improvement in patients under 40 years old (-54.3%). Functional status improved significantly, with the greatest reduction in Lequesne Index scores observed in patients over 80 years old (-32.5%). NSAID use decreased by 84% in younger patients and by 62-71% in older patients or those with obesity. No major systemic adverse events were reported, and transient local reactions occurred in 4% of patients.

Conclusions: This study provides the first real-world evidence of the sustained efficacy and safety of a 10-year US-guided HyalOne^® injection regimen in managing hip OA, highlighting significant improvements in pain, function and NSAID reduction across diverse patient populations.

Background: Hyrimoz^® (Sandoz adalimumab biosimilar) became available in the USA in July 2023, and is administered subcutaneously using a pre-filled autoinjector device, the Hyrimoz Sensoready^® pen. As nurses are often responsible for training patients in the use of autoinjectors, this survey aimed to assess gastroenterology nurses' perceptions of autoinjectors in the USA.

Methods: Eligible participants included nurses in the USA currently working within a gastroenterology practice with experience managing inflammatory bowel disease and with reference to adalimumab, Humira^®. Participants were sent the Hyrimoz Sensoready pen, which was opened during a web-assisted telephone interview. The survey assessed the importance of specified autoinjector device attributes as well as perceptions regarding both the Humira and Hyrimoz Sensoready autoinjector devices.

Results: A total of 123 nurses completed the survey. Participants rated simplicity of use, ease of performing self-injection, ease of learning to use the pen, ability to use an autoinjector pen independently and ease of preparation as the most important autoinjector attributes. When evaluating devices individually, participants awarded higher ratings to the Hyrimoz Sensoready pen over the Humira pen for all evaluated attributes. The greatest differences were reported for visual feedback mechanisms, ease of performing self-injection and the process to initiate injection. When directly comparing the devices, participants preferred the Hyrimoz Sensoready pen over the Humira pen overall, and for all individual attributes. Visual feedback and buttonless activation were the main qualitative features driving this overall preference.

Conclusion: Gastroenterology nurses in the USA expressed strong preferences for the Hyrimoz Sensoready pen versus the Humira pen when rating each device individually, and in direct quantitative and qualitative comparisons.

Vitiligo is a chronic autoimmune disorder characterized by the selective destruction of melanocytes, leading to depigmented patches of skin. Whilst its pathogenesis is not fully understood, genetic predisposition, environmental triggers, oxidative stress, metabolic dysfunction and impaired cell adhesion are all implicated. Vitiligo occurs in two primary forms - non-segmental and segmental - and affects approximately 0.5-2% of the global population. Beyond its physical manifestations, vitiligo imposes a significant psychosocial burden on patients. Current treatments include topical corticosteroids, calcineurin inhibitors, systemic immunosuppressants and narrowband UVB phototherapy. More recently, Janus kinase (JAK) inhibitors have emerged as promising targeted therapies. Topical ruxolitinib 1.5% cream has been approved by both the FDA and EMA for the treatment of non-segmental vitiligo in adolescents and adults, following its demonstrated efficacy and favourable tolerability in clinical trials. Although some risks, such as infection, malignancy, major adverse cardiovascular events and thrombosis, have been raised due to class-wide JAK inhibition concerns, these events appear to be rare with topical use, as no systemic drug accumulation has been reported. Given its safe and therapeutic profile, ruxolitinib is an effective targeted therapy for non-segmental vitiligo. This narrative study aims to review and synthesize the current evidence on the safety, efficacy and therapeutic impact of topical ruxolitinib cream in vitiligo.

Background: Psoriasis is a chronic inflammatory condition that may develop into psoriatic arthritis (PsA) in a significant number of patients. Clinical signs such as enthesitis and nail involvement have been suggested as early indicators of this progression. IL-23 inhibitors have demonstrated effectiveness in psoriasis and, more recently, in PsA. This article aims to evaluate the effect of IL-23 inhibitors on clinical outcomes and progression of PsA in patients with moderate-to-severe psoriasis and early musculoskeletal involvement.

Methods: This was a retrospective, multicentre observational study conducted in Italy. Data were collected from 207 adult patients who had already started treatment with guselkumab, risankizumab or tildrakizumab prior to inclusion. All clinical data, including baseline characteristics and follow-up outcomes, were retrieved retrospectively from medical records across eight dermatology centres.

Results: Enthesitis was observed in 44.8% of patients with joint involvement. Guselkumab was the most commonly used treatment (57%) and demonstrated sustained improvements in Psoriasis Area and Severity Index, Visual Analogue Scale pain and Dermatology Life Quality Index scores. Importantly, no patients with enthesitis treated with guselkumab progressed to overt PsA. At 52 weeks, the average Psoriasis Area and Severity Index score was 0.61, Visual Analogue Scale pain score was 0.59 and Dermatology Life Quality Index score was 0.91.

Conclusion: IL-23 inhibitors have proven effective in managing both skin and joint symptoms in patients with psoriasis at risk for PsA. Whilst the findings suggest that IL-23 inhibitors may help control early musculoskeletal symptoms in patients with psoriasis at risk of PsA, the absence of systematic rheumatological evaluation and the retrospective design preclude definitive conclusions about their disease-modifying potential. These results suggest a potential disease-modifying role that warrants further prospective validation.

Background: Cough is a major symptom of asthma and is associated with poor clinical outcomes. However, current guidelines place little emphasis on the crucial relevance of the cough symptom and its treatment. The objective of this study was to assess the impact of dupilumab on chronic cough (CC) in patients with severe eosinophilic asthma (SEA) and chronic rhinosinusitis with nasal polyps (CRSwNP).

Methods: Patients with CC and SEA, CRSwNP, or SEA plus CRSwNP treated with dupilumab were prospectively included. Patients were evaluated before and after 6 months of treatment by collecting Severe Cough Visual Analogue Scale (SC-VAS) scores and the Leicester Cough Questionnaire (LCQ). A total of 67 patients with CC were included.

Results: Both SC-VAS and LCQ significantly improved after 6 months in the whole group (paired t-test SC-VAS, mean (SD), from 83.13 (11.54) to 38.21; and LCQ, from 1.98 (0.78) to 4.54 (1.35), both p<0.001), and in each disease subset (paired t-test, p<0.001 in all groups). After treatment, 73% and 82% of patients had a clinically meaningful improvement of SC-VAS and LCQ, respectively.

Conclusion: Dupilumab was found to be associated with significant improvement in CC in 50% (n=10) of patients with SEA, in 73% (n=19) of patients with CRSwNP, and in 62% (n=13) of patients with SEA plus CRSwNP, respectively. In this real-life study, dupilumab significantly reduced CC whilst improving quality of life in patients with SEA with or without CRSwNP. These results support the potential role of dupilumab in the treatment of cough as a treatable trait.