RESUMEN
BACKGROUND: Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to direct therapy for VLP. This randomised controlled trial will be the first double-blinded study comparing systemic treatments in VLP and aims to investigate the safety and efficacy of deucravacitinib compared to methotrexate, in patients with VLP who have failed treatment with potent topical corticosteroids. METHODS: A total of 116 women aged ≥ 18 years with moderate to severe VLP (Genital Erosive Lichen Planus (GELP) score ≥ 5) will be recruited. All participants will initially be treated with Diprosone® OV daily, and their outcome will be assessed using the GELP score. At 8 weeks' follow-up, responders (GELP < 5) will be continued on Diprosone® OV. Non-responders (GELP ≥ 5) will be randomised 1:1 in a blinded fashion to receive (i) methotrexate 10 mg weekly + placebo tablet twice daily + folic acid 5 mg weekly or (ii) deucravacitinib 6 mg twice daily + placebo tablet weekly + folic acid 5 mg weekly. The primary endpoint is the difference in the mean change of GELP scores from baseline to week 32 between deucravacitinib and methotrexate groups. DISCUSSION: High-quality evidence guiding the management of women with VLP is lacking. Once completed, this will be the first double-blinded RCT to compare systemic treatments in VLP. The results of this study will provide valuable, high-quality data to guide second-line therapy options for VLP that is recalcitrant to potent topical corticosteroids. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12623000682640. Registered on 26 June 2023.
Asunto(s)
Fármacos Dermatológicos , Compuestos Heterocíclicos , Liquen Plano , Femenino , Humanos , Corticoesteroides/efectos adversos , Australia , Fármacos Dermatológicos/efectos adversos , Ácido Fólico , Glucocorticoides , Liquen Plano/inducido químicamente , Liquen Plano/tratamiento farmacológico , Metotrexato/efectos adversos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Comprimidos , Resultado del Tratamiento , Adolescente , AdultoRESUMEN
OBJECTIVE: To identify reasons for ongoing poor quality of life (pQOL) in a subset of long-term topical corticosteroid-treated vulval lichen sclerosus (VLS) patients. METHODS: A prospective cross-sectional study of patients attending a dermato-gynaecology practice in Sydney, Australia, comparing VLS patients with good quality of life (gQOL) and pQOL, in pre-treatment and long-term treatment groups, using the Vulval Quality of Life Index (VQLI). Demographics, VQLI scores and treatment characteristics were compared between gQOL and pQOL patients. RESULTS: A total of 255 biopsy-proven VLS patients, 67 in pre-treatment and 188 in long-term treated groups were considered. There were 33 (49.3%) pQOL patients in pre-treatment and 13 (6.9%) in treatment groups (p < 0.001). The highest-scoring domain in treated pQOL patients was sexuality (1.7 [interquartile range (IQR) 1.0-2.0]), followed by anxiety [1.3 (IQR 1.0-1.5]), symptoms (1.0 [IQR 0.5-1.5]) and activities of daily living (0.7 [IQR 0.3-1.0]). Compared to treated gQOL, treated pQOL had significantly higher proportions of patients with partial treatment adherence (8 [61.5%] vs 42 [24.0%], p = 0.006), suboptimal disease control (7 [53.8%] vs 20 [11.4%], p < 0.001), scarring progression (3 [23.1%] vs 7 [4.0%], p = 0.024) and urinary incontinence (5 [38.5%] vs 27 [15.4%], p = 0.049). CONCLUSIONS: Only a minority of long-term treated VLS patients reported ongoing pQOL. Of those who did, sexuality and anxiety domains were found to be the main sources of distress. Three major areas distinguishing gQOL from pQOL patients were (1) treatment adherence and disease control, (2) psychological factors and (3) urinary incontinence.
Asunto(s)
Fármacos Dermatológicos , Liquen Escleroso y Atrófico , Incontinencia Urinaria , Liquen Escleroso Vulvar , Femenino , Humanos , Liquen Escleroso y Atrófico/tratamiento farmacológico , Liquen Escleroso Vulvar/tratamiento farmacológico , Calidad de Vida , Estudios Prospectivos , Estudios Transversales , Actividades Cotidianas , Glucocorticoides , Fármacos Dermatológicos/uso terapéuticoRESUMEN
BACKGROUND/OBJECTIVES: To compare the quality of life in patients with vulval lichen sclerosus (VLS), vulval lichen planus (VLP) and chronic vulvovaginal candidiasis (CVVC), as measured by the Vulval Quality of Life Index (VQLI). METHODS: A retrospective, single-centre cohort study was conducted at a combined dermatology and gynaecology practice from March 2018 to November 2021. VQLI scores and patient data were systematically collected and recorded in an online patient database. Treatment regimens were individualised and titrated to clinical response. RESULTS: Over 3 years, a total of 200 women were recruited: 59 with CVVC, 79 with VLP and 62 with VLS. The median duration of follow-up for all patients was 45.43 (16.25-80.89) weeks. At baseline, the median (interquartile range [IQR]) VQLI score was 24.00 (19.00-31.00), 21.00 (12.00-26.00) and 14.00 (7.00-26.00) for CVVC, VLP and VLS, respectively. At follow-up, the median (IQR) VQLI score for CVVC, VLP and VLS was 9.00 (3.00-15.00), 9.00 (3.00-16.00) and 5.00 (2.00-10.00), respectively. All three groups showed a significant improvement in VQLI score (p < 0.0001). At baseline, the highest scoring domains were 'Sexual Function' for CVVC and 'Future Health Concerns' for VLP and VLS. At follow-up, the highest scoring domains were 'Sexual Function' for CVVC and VLP, and 'Future Health Concerns' for VLS. CONCLUSIONS AND RELEVANCE: Vulval disease has an immense impact on QOL, especially in patients with CVVC. The VQLI is useful to clinicians in identifying the unique impact of each vulval condition on a patient's QOL in order to provide better patient-focussed care.
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Candidiasis Vulvovaginal , Liquen Plano , Liquen Escleroso y Atrófico , Enfermedades de la Vulva , Liquen Escleroso Vulvar , Humanos , Femenino , Calidad de Vida , Estudios Retrospectivos , Estudios de Cohortes , Enfermedades de la Vulva/tratamiento farmacológico , Candidiasis Vulvovaginal/tratamiento farmacológico , Liquen Plano/tratamiento farmacológico , Liquen Escleroso Vulvar/tratamiento farmacológicoRESUMEN
OBJECTIVE: We present a case series of acute vulvar aphthosis immediately following COVID-19 vaccination. MATERIALS AND METHODS: We describe 3 cases of acute vulvar aphthosis following Pfizer Comirnaty BNT162b2 mRNA and AstraZeneca (Vaxzevria) ChAdOx1 nCoV-19 COVID-19 vaccination in adolescent girls. RESULTS: All patients developed vulvar aphthosis within a few days after receiving COVID-19 vaccination. The onset of vulvar aphthosis was observed to correlate with the dosing schedule known to produce the highest likelihood of adverse effects, first dose in AstraZeneca (Vaxzevria) ChAdOx1 nCoV-19 and second dose in Pfizer Comirnaty BNT162b2 mRNA COVID-19 vaccine. Two patients required oral prednisolone and hospital admission for indwelling urinary catheterization due to urinary retention. Full disease resolution with no sequalae was achieved in all three patients. CONCLUSIONS: Clinicians should be aware of the possible risk of vulvar aphthosis after COVID-19 vaccine administration. Nevertheless, its occurrence should not prevent affected patients from receiving future doses of COVID-19 vaccines, as the mortality and morbidity of COVID-19 infection significantly outweigh the risk of vulvar aphthosis recurrence.
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Vacunas contra la COVID-19 , COVID-19 , Adolescente , Vacuna BNT162 , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , ChAdOx1 nCoV-19 , Femenino , Humanos , SARS-CoV-2 , VacunaciónRESUMEN
OBJECTIVE: The aim of the study was to investigate the quality of life in vulvar lichen sclerosus (VLS) patients treated with long-term, individualized topical corticosteroids. METHODS: A prospective cross-sectional study comparing new pretreatment and long-term treated VLS patients attending a dermatogynecology practice in Sydney, Australia. Participants were invited to complete the Vulvar Quality of Life Index (VQLI). The VQLI scores were compared between the 2 groups. RESULTS: A total of 204 biopsy-proven VLS patients-68 new pretreatment and 136 treated patients on topical corticosteroids for 2 years or longer. Treated participants scored lower in all VQLI components, including total score (median = 2.0 [interquartile range {IQR} = 0.0-6.0] vs 13.5 [IQR = 7.5-22.0]; p < .001), symptoms (median = 0.5 [IQR = 0.0-0.5] vs 1.3 [IQR = 0.8-2.0]; p < .001), anxiety (median = 0.0 [IQR = 0.0-0.3] vs 0.8 [IQR = 1.1-2.0]; p < .001), activities of daily living (median = 0.2 [IQR = 0.0-0.3] vs 0.5 [IQR = 0.2-1.1]; p < .001), and sexuality (median = 0.0 [IQR = 0.0-0.7] vs 1.0 [IQR = 0.0-2.0]; p < .001). A higher proportion of treated patients achieved total scores of 0-5, representing nil to minimal impact of VLS on quality of life (98 [72.1%] vs 8 [11.8%]; p < .001). Mild and reversible adverse effects were developed in 11 patients (8.1%). Partially compliant patients were 12 times as likely to develop scarring progression than fully compliant patients (7 [22.6%] vs 2 [1.9%]; p < .001). CONCLUSIONS: Long-term, individualized topical corticosteroid treatment is safe and effective in maintaining disease remission and improves the quality of life of VLS patients. Fully compliant patients demonstrate better treatment outcomes than partially compliant patients.
Asunto(s)
Corticoesteroides/uso terapéutico , Satisfacción del Paciente/estadística & datos numéricos , Calidad de Vida , Liquen Escleroso Vulvar/tratamiento farmacológico , Liquen Escleroso Vulvar/psicología , Administración Tópica , Anciano , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Nueva Gales del Sur , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
BACKGROUND/OBJECTIVE: The diagnosis of vulval lichen sclerosus (VLS) is often delayed, and little is known about quality of life (QoL) of women with it prior to receiving diagnosis and treatment. This study aimed to investigate the impact on QoL on patients with previously untreated VLS using the Vulval Quality of Life Index (VQLI). METHODS: A prospective cross-sectional survey of patients attending a dermato-gynaecology practice in Sydney, Australia from March 2018 to November 2019. Patients with a new biopsy-proven diagnosis of VLS not previously commenced on topical corticosteroid treatment were invited to complete the VQLI. RESULTS: A total of 68 participants with median age of 58 (interquartile range, IQR 48-67) years. Median symptom duration was 24 (IQR 11-60) months. Scarring was present in 53% of participants. The median total score was 13.5 (IQR 7.5-22.0), global score 1.0 (IQR 1.0-2.0). Twelve per cent had nil to minimal effect on QoL, 38% had a mild effect on QoL, 28% had a moderate effect on QoL, 22% had a severe effect on QoL, and none had a very severe effect on QoL. The highest-scoring domains were symptoms, followed by sexuality, anxiety and activities of daily living. CONCLUSION: There was significant impairment in all QoL areas of women with untreated VLS. Most experienced moderate-to-severe impairment as a result of the disease and approximately half had already developed scarring at the time of diagnosis. The findings emphasise the importance of improved awareness, early diagnosis and early commencement of treatment in VLS.
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Calidad de Vida , Liquen Escleroso Vulvar/complicaciones , Liquen Escleroso Vulvar/psicología , Actividades Cotidianas , Anciano , Ansiedad/etiología , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Disfunciones Sexuales Fisiológicas/etiología , Disfunciones Sexuales Psicológicas/etiología , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To comprehensively assess cardio-metabolic risk factors and their management in a large sample of outpatients treated with clozapine. METHODS: Observational cross-sectional study of all clozapine users attending specialized clozapine monitoring outpatient clinics in three public hospitals in Sydney, Australia were approached to participate over the one-year period 01/10/2015-30/09/2016. Cardio-metabolic risk factors including metabolic syndrome, risk for future development of diabetes, smoking, physical activity, nutrition, and prescribed medications were assessed at face-to-face interview and through medical record review. Among patients who had cardio-metabolic risk factors, the proportion receiving appropriate management was assessed. RESULTS: Of 451 registered clozapine clinic attenders, 92.2% completed questionnaires and anthropometric measurements. 58.3% met criteria for metabolic syndrome. 79.6% were overweight or obese. 55.9% had blood pressure meeting metabolic syndrome criteria. 46.6% had elevated fasting blood glucose and 55.2% had elevated blood triglycerides. 43.6% were current smokers. Only 10% achieved recommended weekly physical activity levels. Unhealthy food categories were highly consumed. 32.1% were on additional antipsychotics. In the majority of individuals, cardio-metabolic risk factors were untreated or under-treated. CONCLUSIONS: Clozapine use was associated with very high rates of cardiovascular and metabolic risk factors, which were frequently under-treated. Management of both physical and mental health should be prioritized. Polypharmacy should be rationalized. Future research should investigate the effectiveness of smoking cessation and lifestyle interventions in this high-risk population.