Metastatic androgen pathway modulation (mAPM)- sensitive prostate cancer, formerly termed metastatic hormone-sensitive prostate cancer, is a clinically heterogeneous disease in which treatment intensification decisions are guided by metastatic volume and timing of presentation. However, increasing use of advanced imaging and molecular profiling has revealed prognostic scenarios that are not adequately addressed by current algorithms. This study presents a structured multidisciplinary expert consensus exercise, rather than primary clinical research, applying the RAND/UCLA Appropriateness Method to evaluate systemic treatment intensification strategies in mAPM-sensitive prostate cancer. Four anonymized real-world clinical cases representing key prognostic constellations – metachronous/synchronous disease, low/high metastatic burden – were assessed. Panellists rated the appropriateness of doublet therapy versus triplet therapy, including tailored ‘what-if’ variations, through two rounds of anonymous voting with structured discussion. The resulting assessments reflect structured expert judgement integrating available evidence with clinical experience. The panel identified metastatic pattern, particularly the presence and type of visceral involvement, disease dynamics, patient fitness and imaging context as dominant drivers of treatment selection. These findings should be interpreted as consensus-based appropriateness assessments rather than evidence-based treatment recommendations. They support a personalized, multidisciplinary approach to mAPM-sensitive prostate cancer management, emphasizing expert integration of prognostic factors beyond volume-based classifications in clinical scenarios where high-level evidence is limited or not directly applicable. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-multidisciplinary-expert-consensus-on-treatment-intensification-in-metastatic-androgen-pathway-modulation-sensitive-prostate-cancer-a-case-based-rand-ucla-analysis
Background: Heavy menstrual bleeding (HMB) is a common gynaecological condition that significantly affects the quality of life and daily functioning amongst women of reproductive age. In Ayurveda, this condition is described under the category of Asrigdara. Menohelp Syrup, an Ashoka (Saraca asoca)-based Ayurvedic formulation, is traditionally used for the management of HMB. This open-label study evaluated the efficacy and safety of Menohelp Syrup in women with HMB. The study aimed to assess reductions in menstrual blood loss and associated symptoms along with improvement in quality of life. Methods: This open-label clinical study included 228 non-pregnant women with HMB aged 18–45 years. Participants received Menohelp Syrup at a dose of 15 mL twice daily for 90 days. The primary outcome was menstrual blood loss assessed using the Pictorial Blood Assessment Chart. Secondary outcomes included bleeding duration, cycle regularity, pain-related symptoms, haemoglobin and haematological parameters, endometrial thickness, and quality of life assessed using the Menorrhagia Impact Questionnaire. Results: Treatment with Menohelp Syrup resulted in a substantial reduction in menstrual blood loss, with a 54% decrease in estimated menstrual blood loss and a 58% reduction in Pictorial Blood Assessment Chart scores from baseline to day 90. Improvement was also observed in bleeding duration, absorbent product usage, clot passage and bleeding-related urgency. Menstrual pain symptoms improved considerably, with 68.06% of participants reporting complete resolution of dysmenorrhoea at the end of treatment. Mean haemoglobin levels showed modest improvement, whilst endometrial thickness remained stable throughout the study period. No clinically significant adverse events were reported, indicating a favourable safety profile. Conclusions: Menohelp Syrup was well tolerated and was associated with clinically meaningful improvement in HMB, bleeding-related symptom burden and qualityof- life outcomes in women with HMB. These findings support the potential role of Menohelp Syrup as a safe, non-invasive therapeutic option for the management of HMB. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-efficacy-and-safety-of-an-ayurvedic-menohelp-syrup-in-the-management-of-heavy-menstrual-bleeding-menorrhagia-an-open-label-clinical-study
Background: Globally, lung cancer is the foremost contributor to cancer-associated fatalities. Of its various histological sub-types, non-small-cell lung cancer (NSCLC) constitutes the vast majority, accounting for more than 85% of diagnoses. A key driver in this pathology is the mesenchymal–epithelial transition (MET) receptor tyrosine kinase, whose biological activity is governed by the hepatocyte growth factor (HGF) ligand. MET plays a pivotal role in regulating tumour cell proliferation and migration, and aberrant activation of MET signalling is linked to the pathogenesis of NSCLC. Methods: A retrospective analysis of the FAERS database (2016–2025) was conducted to obtain adverse event data pertaining to four MET-targeted therapeutic agents, namely amivantamab, savolitinib, capmatinib and tepotinib. A systematic disproportionality analysis was performed to identify adverse events. Results: Statistically significant differences were observed across most baseline clinical characteristics. Patients taking tepotinib were significantly older (mean 74.7 years) and experience a higher mortality (21%) than those taking amivantamab, savolitinib or capmatinib. In signal detection, amivantamab caused severe cutaneous/ mucosal and infusion-related toxicities. The three c-Met inhibitors led to oedema, with savolitinib distinguished by haematological risks, capmatinib by severe oedema and tepotinib by pulmonary/renal toxicities. In time-toonset analysis, amivantamab’s infusion-related reaction occurred earliest with the highest incidence; savolitinib (pyrexia/hepatic abnormalities) and capmatinib (nausea) appeared early with relatively high incidences; tepotinib’s peripheral swelling was early but had a low incidence. High death-associated adverse drug reactions included dyspnoea, peripheral oedema, decreased appetite and increased creatinine, warranting further investigation. In cluster analysis, key adverse drug reactions (e.g. infusion-related reactions for amivantamab, hepatotoxicity for savolitinib, peripheral swelling for capmatinib and peripheral oedema for tepotinib) primarily occur as isolated events with limited co-occurrence of multiple toxicities. Conclusion: These findings support individualized monitoring and evidence-based treatment selection for older patients, those with comorbidities or patients at high risk with MET-altered NSCLC. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-real-world-safety-assessment-of-met-targeted-therapies-a-pharmacovigilance-analysis-using-the-faers-database
This Editorial introduces the series How to manage thyroid diseases: from autoimmunity to malignancy Special Issue: https://www.drugsincontext.com/special_issues/how-to-manage-thyroid-diseases-from-autoimmunity-to-malignancy
Graves’ disease is an autoimmune disorder and represents the most prevalent cause of hyperthyroidism. Its pathogenesis involves a complex interplay of immunological mechanisms, with a central role attributed to stimulating autoantibodies directed against the thyroid- stimulating hormone receptor (TSHR) expressed on thyroid follicular cells. The differential diagnosis of hyperthyroidism is of paramount importance, including other causes of thyrotoxicosis such as autonomously functioning thyroid adenoma, toxic nodular goitre, various forms of inflammatory or destructive thyroiditis and factitious thyrotoxicosis. The cornerstone of initial therapy for Graves’ disease is the administration of antithyroid drugs (ATDs), whereas radioiodine ablation and total thyroidectomy constitute important therapeutic options, primarily in cases of disease recurrence or when serious adverse events related to ATDs occur. During recent decades, prolonged low-dose ATD regimens have demonstrated comparable safety profiles whilst offering superior efficacy relative to the conventional 18-month treatment course. Emerging therapeutic approaches involve immunomodulatory strategies targeting B lymphocytes, IgG recycling pathways and TSHR itself. Furthermore, the induction of immune tolerance to TSHR represents a promising future direction. This review aims to provide a comprehensive overview of the differential diagnosis of thyrotoxicosis as well as current and evolving therapeutic strategies for the management of hyperthyroidism in Graves’ disease. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-how-to-manage-autoimmune-hyperthyroidism-graves-disease-from-differential-diagnosis-to-emerging-immunological-therapies This article is part of the How to manage thyroid diseases: from autoimmunity to malignancy Special Issue: https://www.drugsincontext.com/special_issues/how-to-manage-thyroid-diseases-from-autoimmunity-to-malignancy
Thyroid eye disease (TED) is a complex autoimmune disorder and the most common extrathyroidal manifestation of Graves’ disease, characterized by orbital inflammation, tissue remodelling, and varying degrees of functional and cosmetic impairment. Although often mild, moderate- to-severe and sight-threatening forms can significantly compromise vision and quality of life. Advances in the understanding of TED pathophysiology – particularly the roles of orbital fibroblasts, thyrotropin receptor and insulin-like growth factor 1 receptor signalling– have transformed its diagnostic and therapeutic landscape. This manuscript provides a comprehensive and updated overview of epidemiology, risk factors, clinical presentation, diagnostic evaluation and management of TED. Current treatment strategies emphasize early risk-factor modification, restoration of euthyroidism, and a multidisciplinary approach tailored to disease activity and severity. Intravenous glucocorticoids remain the cornerstone of therapy for active moderate-to-severe disease, whereas adjunctive immunosuppressive agents and orbital radiotherapy are used in selected cases. The advent of targeted biologic therapies, particularly teprotumumab, as well as rituximab and tocilizumab, has significantly expanded therapeutic options and enabled a more personalized, phenotype-driven approach. Surgical rehabilitation continues to play a pivotal role in the inactive phase. Emerging therapies targeting novel molecular pathways hold promise for further improving patient outcomes. Despite these advances, challenges related to accessibility, cost, long-term safety and optimal patient selection persist. Ongoing research and international collaboration are expected to refine management strategies and enhance the quality of life of patients with TED. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-how-to-manage-thyroid-eye-disease-recent-advances-a-narrative-review This article is part of the How to manage thyroid diseases: from autoimmunity to malignancy Special Issue: https://www.drugsincontext.com/how-to-manage-thyroid-diseases-from-autoimmunity-to-malignancy
Subacute thyroiditis (SAT) is a self-limited inflammatory thyroid disorder classically characterized by anterior neck pain, an enlarged tender thyroid, fever, fatigue, malaise, elevated inflammatory markers and a triphasic course from thyrotoxicosis through hypothyroidism to recovery. It can cause substantial morbidity and remains a frequent diagnostic challenge because it must be distinguished from acute suppurative thyroiditis, Graves’ disease, painless thyroiditis, haemorrhage into a nodule and, rarely, malignant ‘pseudothyroiditis’ (rapidly growing carcinoma). In recent years, the recognized spectrum of triggers has expanded beyond the classical post-viral setting to include SARS-CoV-2 infection or vaccination. This review summarizes current understanding of SAT pathogenesis, including viral and post-viral mechanisms, and HLA-linked susceptibility. We outline the typical and variant clinical phenotypes, emphasising painful classical SAT, painless presentations, pregnancyassociated disease and therapy-related destructive thyroiditis. We then present a practical diagnostic framework based on clinical features, inflammatory markers, thyroid function tests, radionuclide imaging, ultrasound and fine-needle aspiration, when indicated. Management is discussed in a stepwise fashion, including NSAIDs and glucocorticoids for pain and inflammation, β-blockers for symptomatic thyrotoxicosis, selective levothyroxine replacement during the hypothyroid phase, and structured follow-up to detect recurrence and permanent hypothyroidism. Special attention is given to pregnancy and SARS-CoV-2-related SAT cases. Finally, we review longterm outcomes, recurrence risk and future research priorities. The aim is to provide a concise, clinically oriented guide to the contemporary management of SAT and to support rational, evidence-informed decision-making in routine endocrine practice. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-how-to-manage-subacute-thyroiditis This article is part of the How to manage thyroid diseases: from autoimmunity to malignancy Special Issue: https://www.drugsincontext.com/how-to-manage-thyroid-diseases-from-autoimmunity-to-malignancy
Differentiated thyroid cancer has a favourable clinical course. However, a minority of patients with distant metastases lose the ability for radioiodine uptake. In case of refractoriness, the implementation of local therapies, that is radiofrequency/cryoablation or embolization, stabilizes metastasis and delays disease progression. A wait-and-see strategy can be a viable option in slow disease progression. On the other hand, in symptomatic patients with progressive disease, the alternative is systemic therapy with tyrosine kinase inhibitors. Three multi- kinase inhibitors have been approved for this indication: lenvatinib and sorafenib as a first-line option and cabozantinib as a second-line option. Next-generation sequencing allows identification of somatic genetic alterations in tumour tissue, some of which are druggable. Thus, additional selective inhibitors have been approved: larotrectinib and entrectinib for NTRK+ tumours, selpercatinib and pralsetinib for RET+ tumours, and crizotinib, alectinib and lorlatinib for ALK+ tumours. Such a personalized approach increases clinical benefit whilst minimizing adverse events. Future studies should focus on the combination of tyrosine kinase inhibitors and immunecheckpoint inhibitors; currently, there is no strong evidence that redifferentiation strategies add clinical benefit in terms of overall survival or progression-free survival. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-how-to-manage-radioiodine-refractory-thyroid-cancer-in-the-era-of-precision-medicine This article is part of the How to manage thyroid diseases: from autoimmunity to malignancy Special Issue: https://www.drugsincontext.com/special_issues/how-to-manage-thyroid-diseases-from-autoimmunity-to-malignancy
Medullary thyroid carcinoma (MTC) is a rare thyroid malignancy, representing approximately 2–5% of all thyroid cancers. It develops from the parafollicular C cells of the thyroid gland. Calcitonin, produced by parafollicular C cells, is a highly reliable biomarker for both diagnosis and disease monitoring. MTC commonly spreads to cervical lymph nodes and can also lead to distant metastases. Approximately 25% of MTC cases are hereditary, occurring as part of multiple endocrine neoplasia syndromes. Inherited forms are driven by germline mutations in the RET proto-oncogene. Genetic testing enables identification of RET carriers, whilst the risk associated with specific RET variants helps determine the optimal timing for prophylactic or therapeutic surgery. Surgical management remains the cornerstone treatment for MTC. Nevertheless, recurrent or metastatic disease continues to pose therapeutic challenges, requiring individualized strategies such as locoregional interventions, radiotherapy and systemic therapies. Tyrosine kinase inhibitors, along with selective RET inhibitors, represent the main therapeutic strategies for patients whose tumours show rapid progression. This review summarizes current surgical, locoregional and systemic treatment strategies for sporadic and hereditary MTC, focusing on the role of multi-kinase and selective RET inhibitors. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-how-to-manage-medullary-thyroid-carcinoma-current-treatment-strategies This article is part of the How to manage thyroid diseases: from autoimmunity to malignancy Special Issue: https://www.drugsincontext.com/special_issues/how-to-manage-thyroid-diseases-from-autoimmunity-to-malignancy
A 71-year-old man was referred after asymptomatic atrial fibrillation (AF) was incidentally detected during transthoracic echocardiography that showed a preserved left ventricular systolic function with severe left atrial enlargement (antero-posterior diameter 57 mm; area 49 cm²). Therefore, oral anticoagulation with apixaban (5 mg twice daily) and rhythm-control therapy with flecainide (100 mg twice daily) were initiated. After 2 months, AF persisted but flecainide caused a complete left bundle branch block. QRS duration increased from 88 to 155 ms (+76%), QT from 363 to 427 ms, and QTc from 427 to 535 ms, while the JT interval remained unchanged (275 vs 272 ms). This indicated that the QT prolongation was mainly due to delayed depolarisation rather than altered repolarisation. Suspecting use‑dependent sodium channel blockade, flecainide was stopped. Within 48 hours, ECG showed full resolution of the left bundle branch block, a narrow QRS and normal QT (Figure 1). Flecainide’s main ECG effect is use‑dependent sodium channel blockade with QRS widening, while its impact on repolarization is minimal. Apparent QT prolongation with marked QRS widening should therefore be interpreted cautiously. Guidelines advise ECG monitoring after starting flecainide, and a >25% QRS increase should prompt dose reduction or discontinuation. This case shows how serial ECGs and JT interval assessment help distinguish excessive sodium channel blockade from true repolarization abnormalities and avoid overestimating proarrhythmic risk.
Background: Patients with rheumatoid arthritis (RA) generally have elevated levels of rheumatoid factor (RF), which binds to the crystallizable fraction (Fc) of monoclonal antibodies, diminishing tumour necrosis factor inhibitor (TNFi) efficacy. We assessed clinical response to PEGylated, Fc-free certolizumab pegol (CZP) across baseline RF levels in Brazilian patients with RA. Methods: Reported patients (>6 months disease duration) received CZP (200 mg every 2 weeks [Q2W] or 400 mg Q4W) after failure or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs. Data were collected from medical records before initiation, at 3 months and at 6 months of CZP. Patients were stratified by baseline RF quartiles. Disease activity was assessed by the Clinical Disease Activity Index (CDAI). Results: Amongst 51 patients, 49 (96.1%) were women, the mean age (standard deviation [SD]) was 49.8 (13.7) years and 23 (45.1%) were receiving methotrexate. RA duration (SD) was 17.0 (9.5) years. Of 43 patients with baseline RF values, mean RF (SD) was 224.3 (363.5) IU/mL. At baseline, 3 months and 6 months, CDAI for patients overall was 18.6 (10.4), 9.8 (8.6) and 12.5 (11.7); for those with baseline RF≤Q3 (n=34) versus >Q3 (n=9), CDAI was 18.4 (11.0) versus 20.0 (10.7), 9.2 (7.9) versus 8.4 (9.8) and 12.8 (13.2) versus 10.9 (8.9). CDAI remission/ low disease activity rates at baseline, 3 months and 6 months were 4.1%/18.4%, 23.4%/29.8% and 11.9%/40.5%; for those with baseline RF≤Q3 (n=34) versus >Q3 (n=9), CDAI remission/low disease activity rates were 2.9%/20.6% versus 11.1%/0.0% at baseline, 30.3%/24.2% versus 12.5%/50.0% at 3 months and 14.3%/42.9% versus 12.5%/37.5% at 6 months. Conclusion: Baseline RF values did not appear to influence CZP clinical response in this cohort of patients with RA. However, small sample size and data heterogeneity restricted generalizability. Efficacy data from larger cohorts may further elucidate the impact of high RF levels in patients receiving Fc-free biologics. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-lack-of-association-between-rheumatoid-factor-levels-and-clinical-response-to-certolizumab-pegol-in-patients-with-rheumatoid-arthritis-an-observational-study
Recessive dystrophic epidermolysis bullosa is a severe inherited blistering disorder characterized by chronic wounds, fibrosis and systemic complications. Beremagene geperpavec (B-VEC), a topical HSV1-based gene therapy delivering full-length COL7A1, has shown efficacy in clinical trials; however, real-world data remain limited. This retrospective, descriptive case series reports on three patients with genetically confirmed recessive dystrophic epidermolysis bullosa – two children and one young adult – treated between 2024 and 2026 at two Italian tertiary centres. All patients had extensive chronic skin involvement and received weekly topical B-VEC. Clinical data included wound characteristics, response to therapy, supportive care and adverse events. All patients showed clinically meaningful improvement in target wound healing. One child achieved ~70% reduction in the wound area needing treatment; the second had ~50% with shallower morphology and reduced bleeding. The adult, previously enrolled in the GEM-3 trial, achieved over 60% wound closure after reinitiating B-VEC via Italy’s 5% Italian Medicines Agency (AIFA) access programme. No treatment-related adverse events occurred. Adjunctive care included wound hygiene optimization, nutritional and iron support, and pain control. In this small descriptive case series, B-VEC was well tolerated and associated with clinically meaningful improvement in wound healing though outcomes were more variable and, in some cases, less pronounced than those reported in pivotal trials, nevertheless supporting its integration into a comprehensive care model that addresses infection risk, anaemia, nutrition, and wound management. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-topical-gene-therapy-for-severe-recessive-dystrophic-epidermolysis-bullosa-clinical-outcomes-and-multidisciplinary-management-in-three-patients-treated-with-beremagene-geperpa
Background: Topical corticosteroids are essential for the management of inflammatory skin diseases but optimizing efficacy whilst minimizing adverse effects remains critical. Methylprednisolone aceponate (MPA) is a fourth-generation, non-halogenated corticosteroid developed to enhance local activity with limited systemic exposure. This review summarizes its pharmacology, clinical efficacy and safety. Methods: A PubMed search (1990–2025) was conducted to identify relevant studies on MPA in inflammatory dermatoses. Results: MPA’s di-esterified structure and 6α-methyl modification provide potent anti-inflammatory activity with low atrophogenic potential. It is activated within the skin to a highly active metabolite and rapidly inactivated systemically, resulting in minimal systemic absorption. Clinically, MPA provides rapid pruritus relief and high clearance rates in eczematous conditions, including atopic, contact and seborrheic dermatitis. Once-daily application is generally sufficient, supporting adherence. Its availability in multiple formulations allows treatment to be tailored to lesion type and anatomical site. Longterm use is associated with a low risk of skin atrophy or hypothalamic–pituitary–adrenal axis suppression, and allergic sensitization is rare. Conclusions: MPA offers an effective and well-tolerated option for acute and maintenance management of inflammatory skin diseases. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-revisiting-methylprednisolone-aceponate-efficacy-safety-and-current-positioning
Topical medications are commonly used to manage mild-to-moderate psoriasis as adjunctive treatments in patients receiving phototherapy, systemic agents or biologic therapies. Amongst available topical options, the fixed-dose combination of calcipotriol (CAL) and betamethasone dipropionate (BDP) has demonstrated efficacy and tolerability in clinical trials, with most adverse events being mild and transient local reactions. CAL/BDP has recently been formulated as a cream using polyaphron dispersion (PAD) technology to improve its rheological behaviour and sensory characteristics. We describe the use of CAL/BDP PAD-based cream specifically in patients with mild-to-moderate psoriasis across four Italian centres. The first case involves a man with mild-to-moderate scalp psoriasis, in whom CAL/BDP PAD-based cream was effective in this high-impact disease location. The second case focuses on a patient with pretibial psoriasis, a difficult-to-treat site. The third case is of a woman with palmoplantar psoriasis who reported clinical improvement in the lesions and increased treatment compliance compared with her previous therapies. The last case describes the concomitant use of CAL/BDP PAD-based cream with a biologic drug, resulting in optimized lesion clearance. CAL/BDP PAD-based cream appears promising for managing psoriasis in specific contexts such as lesions in difficult-to-treat areas or residual disease during biologic therapy. Further real-world data and clinical observations will be important to clarify how this formulation can be integrated into individualized management strategies for mild-to-moderate psoriasis.
Chronic insomnia is common in adults with intellectual disabilities, yet evidence to guide pharmacological management is limited. We report a real-world case series of five adults with intellectual disabilities and multimorbidity treated with daridorexant, a dual orexin receptor antagonist approved in Europe for insomnia. Daridorexant was associated with marked improvements in sleep quality and quantity, despite complex comorbid sleep, physical, mental and neurodevelopmental disorders. Subject to the limitations of a small, uncontrolled case series, these gains were associated with other reported improvements, including a reduction in challenging behaviours, improved daytime functioning and substantial alleviation of parent and carer burden.
Background: Bimekizumab, a dual IL-17A and IL-17F inhibitor, has demonstrated high efficacy in moderateto- severe psoriasis in clinical trials. However, real-world evidence in patients with moderate disease remains limited. Methods: This retrospective multicentre study evaluated the effectiveness and safety of bimekizumab over 54 weeks in adults with moderate plaque psoriasis treated across five dermatology centres in the Lazio region (Italy). Results: Fifty-nine patients initiated treatment, and 50 completed follow-up; PASI data at week 54 were available for 19 patients, whilst nail data at week 54 were available for 23 patients. Mean Psoriasis Area and Severity Index (PASI) decreased from 9.20 at baseline to 1.31 at week 4, 0.31 at week 16, 0.09 at week 24 and 0.05 at week 54. Nail involvement improved progressively, with mean Nail Psoriasis Severity Index declining from 2.96 at baseline to 0.03 at week 24, with complete clearance observed in all evaluable patients at week 54. More than 60% of patients achieved PASI90 by week 4, almost 90% reached PASI90 and approximately 88% achieved PASI100 by week 16, whilst nearly all patients attained complete clearance (PASI100) by week 54. Responses were comparable between biologic-naive and biologic-experienced patients. Adverse events occurred in 8 patients (13.6%), predominantly mild oral candidiasis, with no serious adverse events or treatment discontinuations. Conclusion: These findings suggest that bimekizumab provides rapid and sustained skin clearance with favourable tolerability in patients with moderate psoriasis, supporting the consideration of early systemic treatment as a potential strategy to reduce disease burden in this population. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-real-life-effectiveness-and-safety-of-bimekizumab-in-patients-with-moderate-plaque-psoriasis-a-54-week-multicentre-study-in-the-lazio-region
The authors wish to make the following corrections to their article: Anderson SL. New and emerging treatments for PBC-related pruritus. Drugs Context. 2026;15:2025-12-3. https://doi.org/10.7573/dic.2025-12-3
Muscle-invasive bladder cancer (MIBC) has a high risk of recurrence following radical cystectomy. Neoadjuvant cisplatin-based chemotherapy has been used for decades to lower recurrence rates but a significant proportion of patients still have disease relapse. Recently, immune-checkpoint inhibitors (ICIs) have been evaluated for patients with MIBC, with some success. This has led to regulatory approval of adjuvant nivolumab, sandwich perioperative durvalumab and sandwich perioperative pembrolizumab with enfortumab vedotin. This review summarizes the history of practice-informing and practice-changing neoadjuvant, adjuvant and sandwich perioperative application of ICIs for MIBC, looks ahead to the promising developments in other ICI-based sandwich perioperative regimens, and highlights controversies surrounding overtreatment versus undertreatment and the need for predictive biomarkers.
Tyrosine kinase 2 (TYK2) inhibition has recently emerged as a novel therapeutic strategy in dermatology, targeting key cytokine pathways involved in immune-mediated inflammatory diseases. Deucravacitinib, an oral, selective TYK2 inhibitor that binds the regulatory pseudokinase domain, modulates signalling mediated by IL-12, IL-23 and type I interferons whilst sparing the broader JAK family, thereby providing targeted immunomodulation with a potentially improved safety profile compared with conventional JAK inhibitors. Pivotal randomized clinical trials have demonstrated robust efficacy and sustained responses in moderate-to-severe plaque psoriasis and psoriatic arthritis, establishing deucravacitinib as an effective systemic therapeutic option. However, clinical trials only partially capture the complexity of cases encountered in routine dermatological practice. In this context, this narrative review summarizes the current clinical evidence on deucravacitinib in dermatology, with a particular focus on real-world data and emerging off-label applications. Real-world studies in psoriasis consistently confirm rapid clinical improvement, durable responses and favourable tolerability across heterogeneous patient populations, including individuals with prior biologic exposure and those with involvement of difficult-to-treat areas such as the scalp, nails, palms and soles. Beyond psoriasis, an expanding body of evidence from case series and observational reports suggests potential therapeutic benefits of TYK2 inhibition in several inflammatory and autoimmune dermatological conditions, including cutaneous lupus erythematosus, dermatomyositis, alopecia areata, lichen planus, granuloma annulare, pityriasis rubra pilaris, overlapping psoriasis/eczema and cutaneous sarcoidosis. These observations highlight the broad immunomodulatory potential of TYK2 inhibition across diverse cytokine-driven pathways implicated in dermatological diseases. Although current evidence outside psoriasis remains limited and largely derived from small case series, the accumulating clinical experience suggests that deucravacitinib may represent a versatile therapeutic option in patients with refractory or complex disease phenotypes. Ongoing clinical trials and future realworld studies will be crucial to better define the longterm efficacy, safety and optimal therapeutic positioning of deucravacitinib across the spectrum of dermatological disorders. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-deucravacitinib-in-dermatology-current-indication-and-existing-off-label-data
Severe pulmonary involvement in primary Sjögren’s syndrome presents a therapeutic challenge, particularly when conventional immunosuppression is insufficient. We report on the case of a 50-year-old woman with interstitial lung disease and profound gas exchange impairment (DLCO 17%). Despite initial treatment with azathioprine, clinical response was inadequate. Early escalation to tocilizumab was followed by marked clinical and radiological improvement. This case highlights the potential importance of timely biologic intervention in severe disease and suggests that advanced functional impairment may still be reversible. Limitations include a single-case design and concomitant therapy. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-primary-sjogrens-syndrome-associated-interstitial-lung-disease-a-case-report-with-favourable-response-to-tocilizumab
