Introduction: Evidence regarding Janus kinase inhibitors (JAKi) in developing interstitial lung disease (ILD) compared with tumor necrosis factor alpha inhibitors (TNFi) and non-tumor necrosis factor inhibitors (non-TNFi) was limited due to selection of controls and regions, including US and Europe.
Aims: To evaluate risk of developing ILD with JAKi compared with individual TNFi and non-TNFi among patients with rheumatoid arthritis (RA).

Methods: We implemented an active comparator new-user design under target trial emulation framework, using Taiwan’s National Health Insurance Research Database. We included patients diagnosed with RA who received JAKi (tofacitinib, baricitinib), TNFi (etanercept, adalimumab, golimumab, or certolizumab), or non-TNFi (tocilizumab, abatacept), defining first dispensing date as index date. We excluded prevalent users, patients with other autoimmune diseases, and patients with malignancy. We defined the outcome as incident ILD events (ICD-9/10-CM codes 515–516, J84) in outpatient or inpatient settings, using an intention-to-treat approach. We applied propensity scores with standardized mortality ratio weighting (SMRW) to mimic randomization in treatment assignment. We used Cox models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs), using individual TNFi or non-TNFi as reference.

Results: We included 18,536 patients (2,411 JAKi, 12,933 TNFi, and 3,192 non-TNFi). After SMRW, we observed no association between JAKi and risk of incident ILD compared with TNFi (HR: 1.11, 95% CI: 0.38–3.18), while we observed that JAKi may be associated with a lower risk of incident ILD compared with non-TNFi (HR: 0.48, 95% CI: 0.21–1.11). Results of comparison between tofacitinib and individual TNFi and non-TNFi were consistent with main findings.

Conclusions: We observed that there was a differential risk of developing ILD with JAKi when compared with TNFi and non-TNFi. Future studies are warranted to explore potential benefit behind JAKi and support clinical evidence on selection of second-line regimens in RA patients.

Keyword: JAKi, Interstitial Lung Disease, TNFi, non-TNFi.

Introduction: Elevated body mass index (BMI) is associated with reduced response to biologic therapies in psoriasis, but whether this association varies across clinical characteristics in ustekinumab-treated patients remains unclear.

Aims: This study aimed to investigate interactions between BMI and clinical characteristics in relation to ustekinumab response in psoriasis.

Methods: We included adults with moderate-to-severe plaque psoriasis who initiated ustekinumab in the Shanghai Psoriasis Effectiveness Evaluation Cohort, a prospective multicenter observational study conducted from November 2022 to March 2024. Treatment response was assessed using time to achievement of PASI75.

Multivariable Cox proportional hazards models were applied to assess interactions between BMI and clinical characteristics including age, gender, baseline PASI, disease duration, prior biologics exposure and comorbidities. Interaction terms were tested using Wald chi-square statistics. For significant interactions, predicted hazard ratios (HRs) were illustrated how the BMI–response association varied across subgroups. A sensitivity analysis was performed using logistic regression with binary outcome defined as achievement of PASI75 at week 16. Statistical significance was defined as a two-sided p value <0.05.

Results: Among 132 patients (median age 45.8 years; 79.6% male; median BMI 24.5 kg/m²; median baseline PASI 12.5), the median time to PASI75 response was 16.4 weeks (n=97).

Disease duration significantly modified the association between BMI and time to PASI75 (P for interaction <0.05). In patients with disease duration <15 years, higher BMI was associated with delayed achievement of PASI75 (HR=0.88, p<0.05), whereas no significant association was observed in those with disease duration ≥15 years (HR=1.06, p=0.37). Sensitivity analyses using binary PASI75 achievement at week 16 yielded consistent findings. No other variables showed significant interactions.

Conclusions: The association between elevated BMI and ustekinumab response was modified by disease duration after adjustment for covariates. These findings warrant further investigation in larger studies.

Keywords: Plaque psoriasis; Ustekinumab; Skin clearance.

Introduction: Biologics are central to management of perianal Crohn’s disease(CD), with guidelines emphasizing early initiation to improve clinical outcomes. However, real-world utilization patterns of biologics have not been systematically characterized in relation to guideline expectations.

Aims: This study aimed to describe the clinical characteristics and treatment patterns of perianal CD in a Japanese cohort.

Methods: We conducted a retrospective real-world cohort study(2018-2024) using the Japan Medical Data Vision(MDV) database. Patients with newly diagnosed CD were classified into pre-CD perianal, post-CD perianal, and non-perianal groups based on the timing of perianal disease onset. Baseline characteristics and treatment patterns, including first treatment for perianal CD, time to biologic initiation, and treatment escalation, were described. Time-to-event analyses and incidence rate ratios(IRR) were used to compare biologic initiation patterns between groups.

Results: Among 1,823 CD patients, 27.2% had perianal disease, including 17.8% pre-CD and 9.4% post-CD perianal groups. Patients with perianal CD were more frequently male and younger(~34 years) at diagnosis and were more likely to initiate biologic therapy than those without perianal involvement(IRR=1.87, 95% confidence interval[CI]:1.62-2.15, p<0.0001), particularly among post-CD perianal group. Nevertheless, biologic therapy was infrequently incorporated into initial perianal CD management(16.3% for pre-CD and 40.9% for post-CD), and substantial delays in initiation were observed (median time to biologic initiation was 229 days [95% CI: 144-583] for pre-CD and 63 days[32-152] for post-CD). Although cumulative biologic uptake increased over follow-up, a considerable proportion of patients did not initiate biologic therapy within the first 12-24 months after perianal CD onset. Among post-CD perianal patients, treatment escalation occurred in approximately one‑third of patients, indicating incomplete treatment optimization.

Conclusions: Biologics remain underutilized for perianal CD in Japan, though perianal CD is associated with earlier adoption. Substantial lagging in biologic utilization indicates potential barriers, highlighting opportunities to improve guideline-concordant care.

Keywords: Crohn’s disease; Biologics; Real-world data.

Introduction: Biological therapies are a major and growing driver of medicine expenditure globally, with tumour necrosis factor (TNF) inhibitors among the most widely used biologics. Biosimilars offer lower-cost alternatives; however, the aggregate cost savings associated with TNF inhibitor biosimilars in Australia have not been comprehensively quantified.

Aims: To estimate Pharmaceutical Benefits Scheme (PBS) cost savings associated with the listing of biosimilars for adalimumab, etanercept, and infliximab used in the treatment of inflammatory arthritis in Australia.

Methods: A retrospective, population-level expenditure analysis was conducted using publicly available, aggregated PBS Item Reports data between 2015 and 2025. Counterfactual scenarios were constructed to isolate the effect of biosimilar entry, while accounting for key PBS pricing mechanisms, including mandated price reductions and price disclosure cycles.

Results: Biosimilar PBS listing was associated with cumulative savings of AU$562,316,855 during the study period. Etanercept biosimilar generated the largest absolute savings of AU$341,527,057 (23.7% reduction). Adalimumab biosimilars generated savings of AU$195,291,010 (9.4% reduction) despite the highest prescription volumes, reflecting delayed biosimilar entry. Infliximab produced the smallest absolute savings of AU$25,498,788 but the greatest relative reduction in expenditure (35.4%). By indication, rheumatoid arthritis accounted for the largest share of savings (AU$306,870,817; 54.6%), followed by ankylosing spondylitis (AU$124,577,892; 22.2%), psoriatic arthritis (AU$114,299,422; 20.3%), and juvenile idiopathic arthritis (AU$16,568,724; 2.9%).

Conclusions: Biosimilar listing of TNF inhibitors was associated with substantial reductions in national medicine expenditure in Australia. The magnitude of savings varied markedly by molecule and was strongly influenced by the timing of biosimilar entry and subsequent pricing mechanisms, highlighting timely biosimilar availability as a critical and modifiable policy lever for maximising cost savings.

Keywords: Biosimilars; Biologics; Pharmacoeconomics

Introduction: Pediatric patients with moderate-to-severe atopic dermatitis (AD) may require systemic therapy such as cyclosporine or methotrexate. However, real-world comparative evidence on broader clinical and developmental outcomes remains limited.

Aims: This study aimed to compare clinical and developmental outcomes following cyclosporine versus methotrexate initiation among pediatric patients aged 2–18 years with AD.

Methods: We applied a target trial emulation framework using retrospective cohort data from the TriNetX US Collaborative Network. We identified new users of cyclosporine or methotrexate aged 2–18 years with AD between 2015 and 2025. Patients with juvenile arthritis, systemic lupus erythematosus, or prior azathioprine or dupilumab use were excluded. One-to-one propensity score matching was performed. Clinical outcomes comprised effectiveness-related outcomes, including systemic corticosteroid rescue, very-high-potency topical corticosteroid exposure, and skin and soft tissue infection (SSTI), as well as safety outcomes, including renal and hepatic dysfunction. Developmental outcomes comprised physical developmental outcomes and neurodevelopmental outcomes. Patients were followed for up to 3 years, and Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).

Results: Among 2,373 eligible patients, 957 initiated cyclosporine and 1,416 initiated methotrexate. After matching, 836 patients were retained in each group. Compared with methotrexate, cyclosporine initiation was associated with higher risks of systemic corticosteroid rescue (HR, 1.12; 95% CI, 1.01–1.25), very-high-potency topical corticosteroid exposure (HR, 1.23; 95% CI, 1.03–1.45), and SSTI (HR, 1.22; 95% CI, 1.01–1.49). Cyclosporine showed numerically lower, but non-significant, risks of renal dysfunction (HR, 0.88; 95% CI, 0.71–1.09), hepatic dysfunction (HR, 0.70; 95% CI, 0.47–1.02), physical developmental outcomes (HR, 0.77; 95% CI, 0.54–1.10), and neurodevelopmental outcomes (HR, 0.89; 95% CI, 0.67–1.18).

Conclusions: These findings suggest that cyclosporine initiation, compared with methotrexate initiation, was associated with less favorable effectiveness outcomes, while no clear differences in safety or developmental outcomes were observed.

Keywords: atopic dermatitis, cyclosporine, methotrexate.

Introduction: Sjögren's syndrome (SS) is a chronic systemic autoimmune disease with a marked female predominance, affecting over 4.5 million individuals in China. Despite this substantial public health burden, large-scale, region-specific real-world data on SS epidemiology and treatment patterns are lacking, particularly in Nanjing, Eastern China.
Aims: To assess the epidemiology and real-world treatment patterns of adult SS patients in Nanjing, Eastern China, from 2020 to 2025.
Methods: This retrospective cohort study analyzed electronic health records from the Nanjing Medical & Healthcare Data Factor Circulation Platform (2018–2025). Adults with ≥1 SS‑specific ICD‑10 code during 2020–2025 were included; those with only localized dryness, prior radiotherapy, HIV, or sarcoidosis were excluded. Pre‑2020 SS diagnoses defined prevalent cases. Incidence and prevalence per 100,000 population were estimated with 95% Poisson confidence intervals. Treatment patterns were assessed, and a Sankey diagram visualized medication transitions.
Results: Of 70,405 screened patients, 57,533 were eligible, yielding 44,666 incident SS cases (93.4% primary, 6.6% secondary). Annual incidence declined from 87.7 to 75.1 per 100,000, while prevalence rose from 193.91 to 243.56 per 100,000. Patients were predominantly female (84.7%) and aged ≥50 years (65.1%). Common comorbidities included hypertension (19.7%) and central nervous system disorders (11.4%); pre-diagnosis, topical therapies were common and oral NSAIDs were used by 17.9%. At initial diagnosis, hydroxychloroquine was most prescribed (40.9%), followed by conventional synthetic DMARDs (21.8%) and corticosteroids (14.6%); biologic use was minimal (0.03%). For the longitudinal treatment analysis, approximately 33.1% (n=14774) of incident patients with adequate follow-up adherence were included.
Conclusions: This large real-world cohort reveals a declining incidence but rising prevalence of SS in Nanjing, predominantly affecting women and individuals aged ≥50. Conventional therapies, especially hydroxychloroquine, dominate initial management with negligible biologic use, highlighting an unmet need for advanced therapeutics and providing evidence to guide regional healthcare planning.
Keywords: Sjögren's syndrome; epidemiology; treatment patterns