Unmet needs in patients with moderate-to-severe plaque psoriasis treated with methotrexate in real world practice: FirST study

Abstract

Background: Methotrexate (MTX) is frequently used in the treatment of moderate-to-severe psoriasis, however, there is limited data on health-related quality-of-life (HRQoL), psoriasis clinical outcomes and hepatic fibrosis in MTX-treated patients in routine clinical practice. Objectives: To investigate the impact of moderate-to-severe psoriasis in MTX-treated patients in Spain regarding to HRQoL, psoriasis clinical data and risk of hepatic fibrosis. Methods: Observational, non-interventional, cross-sectional, retrospective, multicentre study, performed in Spain in moderate-to-severe plaque psoriasis patients treated with MTX > 16 weeks prior to inclusion. Results: Despite ongoing treatment, 17.1% of 457 evaluable patients reported moderate-to-extreme impact on HRQoL (DLQI > 5); 21.4% BSA > 5 and 35.2% moderate-to-severe pruritus (VAS ! 4). Persistent severe psoriasis (PASI ! 10 and/or DLQI ! 10) was observed in 10.7%. Hepatic steatosis was identified in 64.1% of patients (HSI ! 36) and 37.2% of the patients were at-risk of advanced fibrosis which was associated to the MTX treatment duration. Conclusions: The study identified unmet needs in moderate-to-severe plaque psoriasis patients treated with MTX, revealing a significant proportion of sub-optimally controlled patients in terms of HRQoL and different domains of the disease. This study also found patients at-risk of advanced fibrosis, with evidence suggesting a correlation between longer exposures to MTX and higher risk of advanced fibrosis.

Liver fibrosis prevalence and risk factors in patients with psoriasis: A systematic review and meta-analysis

“…We included thirty-seven studies in the quantitative analysis ( 19 , 27 – 62 ), and twelve studies were only used qualitatively ( 55 – 66 ). Nine types of NIT were included: twenty-two TE ( 27 , 29 – 34 , 36 – 42 , 44 – 46 , 48 , 49 , 51 – 53 , 66 ) ( n = 2222), thirteen PIIINP ( 36 , 54 – 65 ) ( n = 947), six FIB-4 ( 19 , 27 , 28 , 32 , 34 , 35 ) ( n = 689), five NAFLD fibrosis score (NFS) ( 28 , 32 , 34 , 35 , 47 ) ( n = 477), four FibroTest/FibroSure ( 34 , 43 , 50 , 66 ) ( n = 285), two AST to Platelet Ratio Index (APRI) ( 27 , 34 ) ( n = 180), two Enhanced Liver Fibrosis score (ELF) ( 54 , 65 ) ( n = 297), one Forns Index ( 34 ) ( n = 63), one FibroMeter ( 34 ) ( n = 64), one Hepascore ( 34 ) ( n = 64), and one Fibrosis Probability Index ( 34 ) ( n = 64) studies. Formulae of NITs mentioned in this review are shown in Supplementary Table 3 .…”

Non-alcoholic fatty liver disease in patients with intestinal, pulmonary or skin diseases: Inflammatory cross-talk that needs a multidisciplinary approach

“…Although some studies associate methotrexate liver toxicity with cumulative dose and treatment time, most find that the risk of liver damage is primarily related to the presence of risk conditions such as obesity, DM2, alcohol consumption, and NAFLD[ 80 , 81 ]. Cyclosporine and acitretin, a retinoid derived from vitamin A, are considered to be diabetogenic and to promote atherogenic dyslipemia and arterial hypertension[ 79 , 82 ].…”

The Essential Role of IL-17 as the Pathogenetic Link between Psoriasis and Metabolic-Associated Fatty Liver Disease

“…A study conducted in Spain in patients (n = 497) treated with MTX found that 64.1% had hepatic steatosis. Moreover, based on the NAFLD fibrosis score and the Fibrosis-4 Index for Liver Fibrosis score, 37.2%, and 26.2%, respectively, were considered to have an intermediate-to-high risk of developing liver fibrosis, which was also associated with a longer duration of treatment [ 24 ].…”