Development and validation of a multivariable risk prediction model for serious infection in patients with psoriasis receiving systemic therapy

BACKGROUND: Patients with psoriasis are often concerned about the risk of serious infection associated with systemic psoriasis treatments. OBJECTIVES: To develop and externally validate a prediction model for serious infection in patients with psoriasis within 1 year of starting systemic therapies. METHODS: The risk prediction model was developed using the British Association of Dermatologists Biologic Interventions Register (BADBIR), and the German Psoriasis Registry PsoBest was used as the validation dataset. Model discrimination and calibration were assessed internally and externally using the C-statistic, the calibration slope and the calibration in the large. RESULTS: Overall 175 (1·7%) out of 10 033 participants from BADBIR and 41 (1·7%) out of 2423 participants from PsoBest developed a serious infection within 1 year of therapy initiation. Selected predictors in a multiple logistic regression model included nine baseline covariates, and starting infliximab was the strongest predictor. Evaluation of model performance showed a bootstrap optimism-corrected C-statistic of 0·64 [95% confidence interval (CI) 0·60-0·69], calibration in the large of 0·02 (95% CI -0·14 to 0·17) and a calibration slope of 0·88 (95% CI 0·70-1·07), while external validation performance was poor, with C-statistic 0·52 (95% CI 0·42-0·62), calibration in the large 0·06 (95% CI -0·25 to 0·37) and calibration slope 0·36 (95% CI -0·24 to 0·97). CONCLUSIONS: We present the first results of the development of a multivariable prediction model. This model may help patients and dermatologists in the U.K. and the Republic of Ireland to identify modifiable risk factors and inform therapy choice in a shared decision-making process

Supplementary Material for: Treatment Satisfaction in Psoriasis: Development and Use of the PsoSat Patient Questionnaire in a Cross-Sectional Study

<b><i>Introduction:</i></b> Evidence supports the potential value of matching patient preferences to treatment recommendations. The aim of the study was to design and validate a questionnaire on treatment satisfaction for clinical decision-making. <b><i>Methods:</i></b> We performed a comprehensive literature search identifying measurable indicators. The complete item pool was condensed to a core set by a multidisciplinary expert panel and tested in a multicentre, observational, cross-sectional study. <b><i>Results:</i></b> The questionnaire consisted of 8 questions, rated on a 5-point Likert scale. In total, 213 dermatology centres included 2,084 patients. The mean disease duration was 19 years. A majority of patients (82.8%) was moderately to very satisfied. 108 patients (5.8%) felt to be bothered by side effects, and 32.1% ascertained that the current therapy had been conducted for too long without success. <b><i>Discussion:</i></b> The PsoSat Questionnaire was shown to be a reliable and valid instrument for measuring therapy-related satisfaction. Further research on its implementation in clinical decision-making is necessary to finally evaluate the benefit of this tool