Benefit-risk profile of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: pooled analysis across six clinical trials.

BACKGROUND: Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor that has been investigated in patients with moderate-to-severe chronic plaque psoriasis. OBJECTIVES: To consider the benefits and risks of tofacitinib in patients with moderate-to-severe psoriasis. METHODS: Data were pooled from one phase II, four phase III and one long-term extension study comprising 5204 patient-years of tofacitinib treatment. Efficacy end points included patients achieving Physician's Global Assessments of 'clear' or 'almost clear', ≥ 75% and ≥ 90% reduction in Psoriasis Area and Severity Index (coprimary end points) and improvements in Dermatology Life Quality Index score, Hospital Anxiety and Depression Scale depression score and Itch Severity Item score, at weeks 16 and 52. Safety data were summarized for 3 years of tofacitinib exposure. RESULTS: Tofacitinib 5 and 10 mg twice daily (BID) showed superiority over placebo for all efficacy end points at week 16, with response maintained for 52 weeks of continued treatment. Tofacitinib improved patients' quality of life and was well tolerated. Rates of safety events of interest (except herpes zoster) were similar to those in the published literature and healthcare databases for other systemic psoriasis therapies. Tofacitinib 10 mg BID demonstrated greater efficacy than 5 mg BID. CONCLUSIONS: Tofacitinib has a benefit-risk profile in moderate-to-severe psoriasis consistent with that of other systemic treatments.

Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study.

BACKGROUND: Pruritus is a clinically important symptom of psoriasis that has a major impact on quality of life (QoL). OBJECTIVE: The objective of this study was to examine pruritus and QoL in patients with moderate-to-severe psoriasis treated with etanercept (ETN) in the PRISTINE clinical trial. METHODS: Patients were randomized (1 : 1, double-blind) to ETN 50 mg QW or 50 mg BIW for 12 weeks, followed by 50 mg QW for 12 weeks. Pruritus was reported as 0 (no itching) to 5 (severe itching). Associations were examined between pruritus and Psoriasis Area and Severity Index, Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Screening (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Euro-Qol 5D (EQ-5D) and Medical Outcomes Study (MOS) Sleep Index II. RESULTS: At baseline, patients (n = 270) had a mean pruritus level of 3.6. Itching (level ≥1) was reported by 96% of patients, 62% of whom had severe itching (level ≥4) and 26% had the highest level of itching. DLQI, HADS-Anxiety, HADS-Depression, FACIT-Fatigue, EQ-5D visual analog scale, and MOS Sleep Index II were significantly associated with itch. At week 12, mean pruritus improvement in the ETN BIW/QW group was greater than in the QW/QW group (2.4 vs. 1.6, P < 0.001), but not at week 24 (2.2 vs. 2.0, P = 0.180). Patients with the most severe itching at baseline (score of 5) had a mean score of 1.7 at week 24. Overall, patients with clinically meaningful pruritus improvement at week 24 reported greater improvement in QoL measures than other patients. CONCLUSION: Most patients with moderate-to-severe psoriasis in this study (96%) reported pruritus. Pruritus improved significantly with ETN therapy and was strongly associated with improvements in QoL. These data support the clinical relevance of pruritus as an important symptom of patients with moderate/severe psoriasis.

Brooke-Spiegler syndrome - report of four families: treatment with CO2 laser.

BACKGROUND: Brooke-Spiegler syndrome is a well known but rare cutaneous disorder characterized by the presence of multiple trichoepitheliomas and cylindromas. METHODS: Four families with Brooke-Spiegler syndrome are described. RESULTS: Spiradenomas developed on the back in two patients. A CO(2) laser was used to treat facial trichoepitheliomas in two patients with good results. CONCLUSIONS: The large number of facial lesions in this syndrome often produce a significant emotional impact. We believe that it is important to provide patients with a good therapeutic option. CO(2) laser therapy may fill this role.

Foliculitis en penacho / Tufted hair folliculitis

Presentamos tres pacientes, dos mujeres y un varón, con diagnóstico de foliculitis en penacho, caracterizada por áreas de alopecia cicatrizal dentro de las cuales emergen conglomerados pilosos de un único orificio folicular. Una de las pacientes fue tratada con infiltraciones con corticoides y nadifloxacina tópica; la otra, con corticoides tópicos y queratolíticos, y el paciente varón, con isotretinoína oral. En los tres se obtuvo una mejoría parcial. La FEP sería una variante de la foliculitis decalvante, caracterizada por la formación del penacho piloso como fenómeno principal, evolución tórpida y tratamiento dificultoso

Zoon's balanitis: presentation of 15 patients, five treated with a carbon dioxide laser.

BACKGROUND: Zoon's balanitis is a chronic erosive process of the penis. The lesions are refractory to conservative topical and some surgical therapy, and frequently require circumcision as a curative measure. METHODS: Fifteen patients with a clinical and histopathologic diagnosis of Zoon's balanitis were studied between October 1991 and October 2001. Five were treated with a carbon dioxide laser. RESULTS: The ages of the patients ranged from 36 to 69 years (average, 50.8 years). All the men were uncircumcised and presented with a discharge and erythematous lesions on the glans penis; the balanopreputial fold was affected in 10 patients and eight had a lesion on the internal surface of the prepuce. One patient was human immunodeficiency virus positive. Five were treated with a carbon dioxide laser. Two relapsed 1 and 3 years later, respectively, and the remaining three have been followed up for 2, 5, and 6 years, respectively, without relapse. One patient developed lichen sclerosus et atrophicus of the prepuce. CONCLUSIONS: We have presented our case study of 15 patients with Zoon's balanitis, and emphasize the possible use of a carbon dioxide laser as an alternative therapy.

A randomized, double-blind, parallel-group, duration-finding study of oral terbinafine and open-label, high-dose griseofulvin in children with tinea capitis due to Microsporum species.

BACKGROUND: Tinea capitis, a common clinical pattern of dermatophyte infection in children is becoming a public health hazard in some countries. Several studies have reported terbinafine to be a safe and well-tolerated fungicidal drug for the treatment of this infection. However, the optimal treatment duration for its use in the treatment of tinea capitis caused by Microsporum species has not yet been determined. OBJECTIVE: (i) To establish the optimal duration for terbinafine treatment to bring about complete cure of tinea capitis due to Microsporum infection in a large paediatric population, and (ii) to obtain information on the maximum therapeutic effect of the existing therapy. PATIENTS AND METHODS: This parallel-group, double-blind, multicentre study was conducted in Europe and South America. Patients were randomized to one of four oral terbinafine treatment arms (6, 8, 10 or 12 weeks treatment) or to an open label, 12-week, high-dose griseofulvin (20 mg x kg(-1) x day(-1)) arm at a 1 : 1 : 1 : 1 : 1 ratio. All patients were followed up for 4 weeks after the end of the treatment phase. RESULTS: In this group of 134 intention-to-treat patients, effective treatment was observed at the end of study in 62% of patients treated with terbinafine for 6 weeks and in 63% treated for 8 weeks. Mycological cure was obtained in 59% and 57%, respectively, and clinical cure in 76% and 80%. In the griseofulvin group, effective treatment was 88%, mycological cure was 76% and clinical cure 96%. However, these high rates were believed to be due to the high dosage of this drug and the prolonged course of treatment. Complete cure was observed at the end of study in 62% patients treated with terbinafine for 6 weeks, in 60% treated for 8 weeks and in 84% patients treated with griseofulvin for 12 weeks. CONCLUSIONS: Although there was no statistical trend between the duration of terbinafine treatment within the groups for complete cure at the end of study, there was a positive correlation between the daily dose of terbinafine (mg x kg(-1)) and complete cure. Terbinafine therapy for 6 weeks could represent an alternative to griseofulvin for the treatment of Microsporum tinea capitis. However, further clinical trials are required in order to optimize the dose regimen to allow higher cure rates to be reached.

Piomiositis no tropical y síndrome de superposición: lupus / Sjõgren / Nontropical pyomyositis and overlap syndrome: systemic lupus erythematosus and Sjõgren syndrome

La Piomiositis (PMS) es una infección primaria del músculo estriado, con progresión insidiosa de una colección purulenta, que se presenta generalmente en áreas tropicales denominándose por esa razón PMS tropical. La incidencia de PMS se ha incrementado últimamente en zonas templadas, denominándose a esta entidad como PMS no tropical, ya que existen algunas características que la diferencian de la PMS clásica. Presentamos el caso de una mujer de 39 años de edad con Síndrome de Superposición, Lupus Erimatoso Sistémico (LES) / Síndrome de Sjõgren (SS), que presentó durante la evolución de su enfermedad una PMS no tropical como ampliación atípica.

Development of cutaneous sarcoidosis in a patient with chronic hepatitis C treated with interferon alpha 2b.

BACKGROUND: Sarcoidosis is a multisystemic granulomatous disorder of unknown etiology that most commonly affects young adults. A probable induction of sarcoidosis by interferons (IFN) has been published. To this date, few cases of cutaneous sarcoidosis inpatients with chronic hepatitis C under interferon treatment have been reported. OBJECTIVE: We describe a 50-year-old woman with chronic hepatitis C who developed lesions of cutaneous sarcoidosis three months after IFN treatment. CONCLUSIONS: The possible role of INF therapy in the development of cutaneous sarcoidosis in a patient with chronic hepatitis C should be considered.

Micosis fungoide folicular / Follicular mycosis fungoides

La micosis fungoide folicular (MFF) es una variante clínica infrecuente de MF. Presentamos el caso de un paciente de 51 años de edad con localización en cuero cabelludo y buena respuesta al tratamiento. Realizamos además una revisión de la literatura

Láser de CO2 en el tratamiento de moluscos contagiosos en pacientes HIV+ / CO2 laser treatment for molluscum contagiosum in HIV+ patients

El tratamiento de moluscos contagiosos gigantes y múltiples en pacientes HIV+ implica un gran desafío. La resolución espontánea se observa en pacientes inmunocompetentes, pero esto no ocurre habitualmente en individuos inmunocomprometidos. Se han empleado varias terapéuticas, sin embargo no se han reportado datos convincentes de tratamientos exitosos. Describimos dos pacientes HIV+ con moluscos contagiosos recalcitrantes, diseminados y gigantes, quienes respondieron favorablemente al tratamiento con láser de CO2. Durante el seguimiento de quince y dieciocho meses, no hemos observado recidivas en estos pacientes