Why carry out this study?
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Among first-line treatments for psoriasis, dimethyl fumarate (DMF) demonstrated a favorable efficacy and safety profile in short- and long-term observation; however, scarce evidence is available for DMF treatment in real-life practice at the time of the COVID-19 pandemic |
It has been suggested that the immunomodulatory, anti-oxidative and anti-inflammatory properties of DMF could reduce the cytokine storm caused by severe COVID-19 |
We aimed to assess the long-term effectiveness and safety of DMF monotherapy in moderate-to-severe psoriasis patients during the COVID-19 pandemic period |
What was learned from the study?
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DMF monotherapy significantly improved all disease activity indexes showing a good safety profile and an optimal drug survival rate |
DMF monotherapy was an effective and safe treatment option in moderate-to-severe psoriasis also in four patients who developed SARS-CoV-2 infection |
Introduction
Methods
Study Design
Patients
Assessments, Endpoints and Follow-Up Procedures
DMF Treatment Protocol
Data Analysis
Results
Study Population
Mean clinical characteristics, n (range) | |
PASI (0–72) | 13.07 (6.8–56.2) |
PGA (0–5) | 2.84 (1–5) |
Itch VAS (0–10) | 3.22 (0–10) |
DLQI (0–30) | 13.09 (2–23) |
PGA-face (0–5) | 2 (1–5) |
PGA-genital (0–5) | 3.5 (3–4) |
PGA-scalp (0–5) | 2.84 (1–5) |
Mean peripheral blood hematological parameters, n (range) | |
Lymphocytes (× 10^3/µl) | 2.83 (1.3–4.92) |
Neutrophils (× 10^3/µl) | 5.78 (2.63–8.2) |
NLR, n | 2,20 (0.86–5.15) |
CRP (mg/dl) | 2.98 (0.1–78) |
ESR (mm/h) | 15.11 (2–57) |
DMF Usage
Effectiveness
Safety
Hematological Parameters
Adverse Events and Dropouts
SARS-CoV-2 Infection
Age | 53 | 57 | 65 | 67 |
Sex | Male | Male | Male | Male |
BMI (kg/m2) | 26.0 | 27.5 | 24.8 | 28.4 |
Age of plaque psoriasis onset | 32 | 16 | 62 | 43 |
Comorbidity | Hypertension and dyslipidemia | Hypertension and dyslipidemia | Hypertension and cardiac arrhythmia | Hypertension |
Previous treatments | Acitretin and topical treatment | Ciclosporin and topical treatment | Topical treatment | Ciclosporin and topical treatment |
Mean clinical characteristic | PASI 18.1, PGA 4, DLQI 15, nail PGA 2 | PASI 9, PGA 1, DLQI 19, face and scalp PGA 2 | PASI 15, PGA 4, DLQI 20, scalp PGA 3 | PASI 15.7, PGA 2, DLQI 15, scalp PGA 4, nail PGA 3 |
Week of DMF treatment—development of SARS-Covid-2 positivity | Week 5 | Week 2 | Week 26 | Week 12 |
COVID-19 symptomatology | Fever, cough and general malaise for 10 days, without complication toward interstitial pneumonitis | No specific symptoms | Transient fever with auto-resolution and coexistent dysgeusia and general malaise | Loss of taste and smell |
Hospitalization | No | No | No | No |
DMF treatment discontinuation | No | No | No | No |