Effect of sex in systemic psoriasis therapy: Differences in prescription, effectiveness and safety in the BIOBADADERM prospective cohort

The effect of sex on systemic therapy for psoriasis has not been well studied. The aim of this study was to analyse a large multicentre Spanish cohort of 2,881 patients with psoriasis (58.3% males), followed from January 2008 to November 2018, to determine whether sex influences prescription, effectiveness of therapy, and the risk of adverse events. The results show that women are more likely than men to be pre-scribed biologics. There were no differences between men and women in effectiveness of therapy, measur-ed in terms of drug survival. Women were more likely to develop adverse events, but the difference in risk was small and does not justify different management. Study limitations include residual confounding and the use of drug survival as a proxy for effectiveness.The BIOBADADERM project is promoted by the Fundación Piel Sana Academia Española de Dermatología y Venereología, which receives financial support from the Spanish Medicines and Health Products Agency (Agencia Española de Medicamentos y Productos Sanitarios) and from pharmaceutical companies (Abbott/Abbvie, Pfizer, MSD, Novartis, Lilly, Janssen and Almirall)

Effectiveness and safety of Methotrexate in psoriasis: an eight-year experience with 218 patients

Background: Methotrexate (MTX), a traditional antipsoriatic drug, is very frequently used either as monotherapy or in combination with other systemic drugs. Objectives: To assess the effectiveness and safety of MTX in psoriasis in usual clinical practice. Methods: We conducted a retrospective study. We performed an electronic and manual chart review of patients treated with MTX in the Psoriasis Unit of our Hospital from January 2007 to December 2014. Demographic and clinical data, PASI/DLQI scores and reasons for suspension of all patients treated with MTX in usual clinical practice were recorded. Results: Two hundred and eighteen patients were included. MTX was administered in 67% of cases as the first systemic treatment. The average treatment duration was 17.2 ± 13.6 months. All patients were subjected to clinical and laboratory monitoring. About 33.5% of them achieved a reduction of 75% or more of the initial PASI at week 12, 34.9% at week16, 44.7% at week 24, and 52.8% at week 48. A 3.3% had to discontinue the therapy due to analytical hepatic (2.8%) or renal (0.5%) abnormalities. Only one patient experienced severe interstitial pneumonitis and none required liver biopsy. Conclusions: MTX is an effective and safe option for the treatment of psoriasis in the real-world clinical practice

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products

The risk of hepatic adverse events of systemic medications for psoriasis: a prospective cohort study using the BIOBADADERM registry

Background Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies. Objectives To describe the liver safety findings of conventional and modern systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug. Methods All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs. Results Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years [CI 95% 18–23]), followed by NAFLD (8 cases per 1000 patients-years [95% CI 6–10]). Methotrexate (aIRR 3.06 [2.31–4.4]; p = 0.000) and cyclosporine (aIRR 2.37 [1.05–5.35]; p = .0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-α agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD. Conclusions Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis

Effect of Sex in Systemic Psoriasis Therapy: Differences in Prescription, Effectiveness and Safety in the BIOBADADERM Prospective Cohort.

The effect of sex on systemic therapy for psoriasis has not been well studied. The aim of this study was to analyse a large multicentre Spanish cohort of 2,881 patients with psoriasis (58.3% males), followed from January 2008 to November 2018, to determine whether sex influences prescription, effectiveness of therapy, and the risk of adverse events. The results show that women are more likely than men to be prescribed biologics. There were no differences between men and women in effectiveness of therapy, measured in terms of drug survival. Women were more likely to develop adverse events, but the difference in risk was small and does not justify different management. Study limitations include residual confounding and the use of drug survival as a proxy for effectiveness