Treatment of recurrent aphthous stomatitis with oral roflumilast, a multicenter observational study.

INTRODUCTION: Severe recurrent aphthous stomatitis (RAS) represents a therapeutic challenge because of its impact on the patient's quality of life. Additionally, no approved systemic therapies are available. Roflumilast, a phosphodiesterase-4 inhibitor, has shown promise in other inflammatory dermatological conditions. This study aimed to assess the characteristics, effectiveness, and safety of roflumilast in treating RAS in routine clinical practice. METHODS: This is a single cohort ambispective observational study conducted in five Spanish centers. Twenty-two patients with RAS treated with roflumilast participated. Data collection included demographic, clinical, and outcome variables. Statistical analysis compared the outcomes of 12 weeks of roflumilast treatment with a similar prior period without treatment. RESULTS: During treatment with roflumilast, a significant reduction in flare-ups (88%) and oral ulcers (94%) was observed compared to the untreated period. A reduction in pain (66%) and ulcer duration (63%) was observed. Adverse effects (AEs) occurred in 13 patients, predominantly headache and gastrointestinal disturbances. Most of these were self-limiting or manageable with dose adjustment. Treatment was withdrawn in three cases, mainly because of AEs. CONCLUSIONS: This study suggests that roflumilast may effectively treat RAS by reducing the number of flare-ups and ulcers, their duration, and the symptomatology produced by the ulcers. In addition, roflumilast has a good safety profile, is well tolerated at low doses, and does not require close monitoring. These characteristics and its favorable economic profile make roflumilast a promising therapeutic option in this pathology.

Clinical and Demographic Features of 49 Patients With Human Monkeypox Virus-Confirmed Infection in a Tertiary Care Center in Valencia, Spain: A Descriptive Study.

Monkeypox is a previously rare viral zoonosis affecting predominantly the African continent. Since May 2022, an increasing number of cases with no known epidemiologic link to Africa have been reported for the first time in the rest of the world. We described the epidemiologic and clinical characteristics of all patients attended at our center until August 9 with a confirmed diagnosis of monkeypox. Forty-nine patients were included. The mean age was 37.6 years. Ninety-eight percent of patients were male, 96% were men who have sex with men, and 4% were heterosexual. Thirty-one percent of patients had a history of human immunodeficiency virus infection. Ninety-six percent of patients declared a unprotected sexual relationship before the onset of symptoms, and 41% had a history of recent travel. Ninety-eight percent of patients presented with cutaneous involvement affecting the genital (59%), perianal (41%), and perioral (35%) regions. Systemic symptoms were present in 80% of the patients and included lymphadenopathies (71%), asthenia (65%), fever (65%), headache (37%), arthromyalgias (45%), pharyngitis (35%), proctitis (29%), and dysuria (6%). Coinfection by other sexually transmitted infections was detected in 20% of patients. The sensitivity values of polymerase chain reaction test for monkeypox in urethral, anal, and oropharyngeal exudates analyzed were 88%, 79%, and 68%, respectively. Complications included a myopericarditis that represented the only hospitalized patient, edema (8%) and bacterial superinfection (4%). No deaths were reported. The findings of this case series support the sexual contact as the main route of transmission of the disease and highlight some atypical clinical presentations not described in endemic cases.

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.

Drug holiday approach for Vismodegib treatment in patients with nevoid basal cell carcinoma syndrome: Three cases from real clinical practice.

Sonic hedgehog pathway inhibitor Vismodegib is the first systemic treatment to be approved for metastatic or locally advanced basal cell carcinoma non-subsidiary of surgical treatment, and appears to be a promising treatment option for patients with nevoid basal cell carcinoma syndrome. In these patients, where repeated or prolonged treatment may be necessary, the psychological exhaustion caused by the chronicity of less severe adverse effects appears as the main limiting factor in the persistence of the drug in the long term and in the willingness of patients to take the drug again after its suspension. We report our experience with three cases where a drug holiday approach was effective in decreasing the intensity of adverse effects or improving the patient's subjective tolerance to the drug while maintaining clinical response.

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.

BACKGROUND: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. OBJECTIVE: 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. METHODS: 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. RESULTS: 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 <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). LIMITATIONS: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. CONCLUSION: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.

Prevalence of non-alcoholic fatty liver and liver fibrosis in patients with moderate-severe psoriasis: A cross-sectional cohort study.

BACKGROUND/OBJECTIVES: Several studies have reported that non-alcoholic fatty liver disease (NAFLD) is more frequent in patients with psoriasis, but few have reviewed the presence of liver fibrosis in those patients. METHODS: Cross-sectional cohort, single-centre study, continuously selecting all patients with moderate-severe psoriasis seen at the Psoriasis Unit of a Tertiary Hospital. The grade of liver steatosis was assessed using liver ultrasound, and the quantity of liver fibrosis was graded using a transitional vibration-controlled elastography (Fibroscan®). RESULTS: A total of 71 patients (66.2% male) were included, with an average age of 46.6 years old. The maximum historical PASI average was 14.4 while the baseline PASI average at the time of the study was 2. A third (36%) of patients met the criteria for metabolic syndrome 52% of patients had steatosis; being male, having metabolic syndrome comorbidities, elevated AST/ALT enzymes, dyslipidemia and high initial PASI were significantly related. 14% of patients had moderate liver fibrosis (≥7.6 KPa). In 30% of them, no ultrasound liver steatosis was observed. CONCLUSIONS: Elastography may be a useful tool along with ultrasound to evaluate liver disease in patients with psoriasis.

Cytoimmunofluorescence Diagnosis in Surgically Induced Pemphigus Foliaceus.

Pemphigus foliaceus is an autoimmune bullous disease with autoantibodies against desmoglein 1. Case reports of pemphigus after surgery have also been described, which may simulate an infection of the surgical wound, a contact dermatitis, or even a tumor recurrence. Cytoimmunofluorescence can help to establish a rapid diagnosis.

Coexistence of Pemphigus Foliaceus and Grover Disease After a Radical Surgery for Basal Cell Carcinoma.

The differential diagnosis of Grover disease (GD) includes pemphigus foliaceus. However, the focal nature of the histologic findings and negative direct immunofluorescent point to the diagnosis of GD. It has been associated with a variety of systemic and cutaneous diseases, but its association with other primary acantholytic disorders has been rarely documented. In this article, we describe the first case of GD in association with pemphigus foliaceus.