Summary Background Reflectance confocal microscopy (RCM) is a noninvasive method for skin assessment, allowing entire lesion evaluation up to the papillary dermis. RCM is a potentially attractive alternative to punch biopsy (PB) in basal cell carcinoma (BCC). Objectives To determine the diagnostic accuracy of RCM vs. PB in diagnosing and subtyping BCC, and to study patient satisfaction and preferences. Methods Patients with a clinically suspected primary BCC were randomized between RCM and biopsy. Conventional surgical excision or follow‐up were used as reference. Sensitivity and specificity for BCC diagnosis and subtyping were calculated for both methods. BCC subtype was stratified based on clinical relevance: aggressive (infiltrative/micronodular) vs. nonaggressive (superficial/nodular) histopathological subtype and superficial vs. nonsuperficial BCC. Data on patient satisfaction and preferences were collected using a questionnaire and a contingent valuation method. Results Sensitivity for BCC diagnosis was high and similar for both methods (RCM 99·0% vs. biopsy 99·0%; P = 1·0). Specificity for BCC diagnosis was lower for RCM (59·1% vs. 100·0%; P < 0·001). Sensitivity for aggressive BCC subtypes was lower for RCM (33·3% vs. 77·3%; P = 0·003). Sensitivity for nonsuperficial BCC was not significantly different (RCM 88·9% vs. biopsy 91·0%; P = 0·724). Patient satisfaction and preferences were good and highly comparable for both methods. Conclusions Biopsy outperforms RCM in diagnosing and subtyping clinically suspected primary BCC. This outcome does not support routine clinical implementation of RCM, as a replacement for PBs in this patient group.

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Background: Incorporating patient-related factors associated with treatment outcomes could improve personalized care in older patients with basal cell carcinoma (BCC).Objective: To evaluate and identify predictors of treatment burden, treatment outcomes, and overall survival in patients aged $70 years, surgically treated for BCC in the head and neck area. Methods:The data from the prospective, multicenter Basal Cell Carcinoma Treatment in Older Adults (BATOA) cohort study were extracted to evaluate the experienced treatment burden (visual analog scale, 0-10 cm; lower scores indicating higher treatment burden), treatment outcomes, and mortality.Results: A total of 539 patients were included (median age, 78 years). The patients experienced a low overall treatment burden (median, 8.6) and good cosmetic results. The predictors of higher treatment burden were instrumental activities of daily living (iADL) dependency, female sex, complications, larger tumor diameter, and polypharmacy. Thirty-five patients (6.5%) died (none of the deaths were due to BCC) within the follow-up period; the predictors of mortality were increasing comorbidity index and iADL dependency. No difference in these outcomes was seen between Mohs micrographic surgery and conventional excision after correction for covariates. Age was not significantly associated with any outcome.Limitations: A selection bias may exist owing to the observational design. Conclusion:BCC management decisions based on chronological age alone should be avoided, whereas more attention is recommended for patient-related factors. Based on these data, early BCC intervention is beneficial for robust and fit patients or those experiencing symptoms.

Background Psoriasis is a common inflammatory disease in any age group, but also in older patients (≥ 65 years of age). Since older patients are often excluded from clinical trials, limited data specifically on this growing population are available, e.g. regarding the safety and performance of biological treatment. Aims We aimed to give insight into this specific population by comparing the drug survival and safety of biologics in older patients with that in younger patients. Methods In this real-world observational study, data from 3 academic and 15 non-academic centers in The Netherlands were extracted from the prospective BioCAPTURE registry. Biologics included in this study were tumor necrosis factor (TNF)-α, interleukin (IL)-17, IL-12/23, and IL-23 inhibitors. Patients were divided into two age groups: ≥ 65 years and < 65 years. The Charlson Comorbidity Index (CCI) was used to measure comorbid disease status, and all adverse events (AEs) that led to treatment discontinuation were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. All AEs that led to treatment discontinuation were studied to check whether they could be classified as serious AEs (SAEs). Kaplan-Meier survival curves for overall 5-year drug survival and split according to reasons of discontinuation (ineffectiveness or AEs) were constructed. Cox regression models were used to correct for possible confounders and to investigate associations with drug survival in both age groups separately. Psoriasis Area and Severity Index (PASI) scores during the first 2 years of treatment and at the time of treatment discontinuation were assessed and compared between age groups. Results A total of 890 patients were included, of whom 102 (11.4%) were aged ≥ 65 years. Body mass index, sex, and distribution of biologic classes (e.g. TNFα, IL12/23) were not significantly different between the two age groups. A significantly higher CCI score was found in older patients, indicative of more comorbidity (p < 0.001). The 5-year ineffectivenessrelated drug survival was lower for older patients (44.5% vs. 60.5%; p = 0.006), and the 5-year overall (≥ 65 years: 32.4% vs. < 65 years: 42.1%; p = 0.144) and AE-related (≥ 65 years: 82.1% vs. < 65 years: 79.5%; p = 0.913) drug survival was comparable between age groups. Of all AEs (n = 155) that led to discontinuation, 16 (10.3%) were reported as SAEs but these only occurred in younger patients. After correcting for confounders, the same trends were observed in the drug survival outcomes. Linear regression analyses on PASI scores showed no statistical differences at 6, 12, 18, and 24 months of treatment between age groups. Conclusions This study in a substantial, well-defined, prospective cohort provides further support that the use of biologics in older patients seems well-tolerated and effective. Biologic discontinuation due to AEs did not occur more frequently in older patients. Older patients discontinued biologic treatment more often due to ineffectiveness, although no clear dif...

Optimal selection of systemic therapy in older adults with psoriasis can be challenging, due to sparse evidence-based guidance. This multicentre retrospective study investigated the safety of systemic therapy with causality assessment in a real-world cohort of older adults (≥ 65 years) with psoriasis. Data from 6 hospitals on (severe) adverse events were collected, causality assessment performed and incidence rate ratios calculated. Potential predictors for adverse events-occurrence were studied using multivariable logistic regression analysis. In total, 117 patients with 176 treatment episodes and 390 patient-years were included, comprising 115 (65.3%) and 61 (34.7%) treatment episodes with conventional systemic therapy and biologics/apremilast, respectively. After causality assessment, 232 of 319 (72.7%) adverse events remained and were analysed further, including 12 severe adverse events. No significant differences in incidence rate ratios were found between the systemic treatment types. In regression analysis, increasing age was associated with causality assessed adverse events-occurrence (odds ratio 1.195; p=0.022). Comorbidity, polypharmacy, and treatment type were not associated with causality assessed adverse events-occurrence. In conclusion, increasing age was associated with a higher causality assessed adverse events-occurrence. Causality assessed severe adverse events were rare, reversible and/or manageable in clinical practice. In conclusion, the safety profile of systemic antipsoriatic therapy within this population is reassuring.

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Background: Limited real-world studies are available comparing infection risk between biologics for psoriasis.Objectives: The primary aim was to determine the differential effect of currently available biologics on the risk of respiratory tract infections (RTI) among psoriasis patients in a real-world setting. Secondary aims were to explore the differential risk of all types of serious infections (SI) between biologics and to provide an early overview of SARS-CoV-2 infections during the pre-vaccine era. Methods: Crude incidence rates of RTI and SI were calculated per 100 patient-years (PY) per biologic using prospective BioCAPTURE data. Negative Binomial Regression modeling was used to explore the risk of RTI. Frailty Cox proportional hazards modeling was used to estimate hazard ratios for the risk of the first SI. Confounders adjusted for both models were selected by a directed acyclic graph. A post hoc exploratory analysis of SARS-CoV-2 infection incidence rates during 2020 was performed. Results: We included 714 patients with 1325 treatment episodes (3607.7PY between 2005 and 2020), in which 2224 RTI and 63 SI occurred. Among RTI, 1.3% were serious. The crude incidence rates were 61.7 (95% confidence interval [CI]: 59.1-64.3) per 100PY for RTI, and 1.8 (95% CI: 1.4-2.2) per 100PY for SI. Confounder adjusted analyses showed no differential risk of RTI between adalimumab, etanercept, infliximab, ustekinumab, secukinumab, ixekizumab and guselkumab. For SI, no differential risk was found between biologics either. Extended single-center data showed 3.8 (95% CI: 2.2-6.1) SARS-CoV-2 infections per 100PY in 2020. Conclusions: Confounder adjusted analyses showed no differential risks of RTI or SI between included biologics (adalimumab, etanercept, infliximab, ustekinumab, secukinumab, ixekizumab and guselkumab) in a prospective psoriasis patients cohort. In general, absolute numbers of all types of SI were low.

Exclusion by age, cardiovascular comorbidity and malignancies are the main factors that impact generalizability of evidence from trials to the real-world situation in older adults with psoriasis Dear Editor, Psoriasis is prevalent in the growing group of older adults (≥65 years), resulting in an absolute increase in this population in dermatological practice. Optimal treatment selection in this population is often complicated by comorbidity, comedication use and limited evidence-based guidance. 1,2 The scarcity of available evidence for this population can be explained by the high (in)direct exclusion rates of older adults from randomized clinical trials (RCTs). 3 Therefore, the external validity or generalizability of RCT findings