Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis: Subgroup analysis of Latin American patients in the phase 3 randomized UNCOVER-3 study.

BACKGROUND AND OBJECTIVES: Ixekizumab demonstrated greater efficacy than placebo and etanercept in UNCOVER-3. Subgroup analysis of Latin American patients was performed. We report 12-week and 60-week data. PATIENTS AND METHODS: Analysis included 102 Latin American patients randomized to receive placebo (n=14), etanercept 50mg twice weekly (n=30), or ixekizumab 160-mg starting dose followed by 80mg every 2 weeks (Q2W; n=29) or every 4 weeks (Q4W; n=29). At week 12, patients maintaining efficacy response and adequate overall safety were assigned, at the discretion of the investigator, to long-term extension with ixekizumab Q4W. RESULTS: At week 12, Psoriasis Area and Severity Index (PASI) 100 scores were 0%, 20.0% (p=0.075 vs placebo), 62.1% (p<0.001 vs placebo; p=0.001 vs etanercept), and 48.3% (p=0.002 vs placebo; p=0.023 vs etanercept) for placebo, etanercept, ixekizumab Q2W, and ixekizumab Q4W, respectively. Among patients who continued therapy up to week 60 (n=97), PASI 100 scores were 71.4%, 60.0%, 77.8%, and 57.7% for patients who received induction placebo, etanercept, ixekizumab Q2W, and ixekizumab Q4W, respectively (non-responder imputation). By week 60, ≥1 serious adverse event was experienced by 7.1% (n=1/14), 3.3% (n=1/30), 14.8% (n=4/27), and 0% (n=0/26) of patients who received induction placebo, etanercept, ixekizumab Q2W, and ixekizumab Q4W, respectively. There were no cases of active tuberculosis with ixekizumab treatment through 60 weeks. CONCLUSIONS: In Latin American patients, both ixekizumab dosing regimens demonstrated greater efficacy than etanercept for treating psoriasis over 12 weeks. The safety profile of ixekizumab through 60 weeks was well tolerated and consistent with the overall profile.

Clinical Characteristics and Outcomes in a Population With Disseminated Herpes Zoster: A Retrospective Cohort Study. / Características clínicas y evolutivas de una población con herpes zoster diseminado: un estudio de cohorte retrospectiva.

INTRODUCTION: Shingles is the cutaneous expression of the reactivation of latent varicella zoster virus infection in sensory ganglia. It presents as vesicles in the corresponding dermatome. The condition is called disseminated herpes zoster (DHZ) when more than 2 contiguous dermatomes are affected, more than 20 vesicles are observed outside the initial dermatome, or involvement is systemic. DHZ is rare and most frequently occurs in immunocompromised patients. OBJECTIVES: To describe the epidemiology, predisposing factors, clinical presentation, laboratory findings, and clinical course of patients with DHZ, and to compare the findings in immunocompromised and immunocompetent patients. METHODOLOGY: We analyzed a retrospective case series of adults hospitalized between February 2010 and October 2015. RESULTS: Forty-one patients with virologically confirmed manifestations of DHZ were included. Stress as a trigger factor was detected in 39% and immunodepression in 58.5%. Immunocompromised patients were younger than the immunocompetent patients (mean ages, 60.5 vs 82 years, P<.01). The 8 immunocompetent patients with no detectable trigger factors were older (mean age, 85 years). In 95% of cases, DHZ was initially limited to a single dermatome and then spread to other dermatomes or became disseminated. Thrombocytopenia was detected in 56% of cases. Complication rates were similar in immunocompromised and immunocompetent patients (54% vs 59%, P>.01). Six patients died; there was no difference in mortality between the 2 groups. CONCLUSION: This study provides evidence on the relationship between DHZ, the presence of underlying immunodepression, and complications. Immunosenescence may play an important role in the onset of this disease in older immunocompetent patients.

Lentigo Maligna: Keys to Dermoscopic Diagnosis. / Lentigo maligno. Claves en el diagnóstico dermatoscópico.

Dermoscopy is a noninvasive technique that improves accuracy in the diagnosis of cutaneous lesions. The recognition and differential diagnosis of lentigo maligna (LM) and lentigo maligna melanoma (LMM) is challenging, especially in the early stages when there are no distinctive clinical features. Early diagnosis and appropriate treatment can improve prognosis. Several dermoscopic features have been described for LM and LMM. The following 4 criteria in combination have achieved a diagnostic sensitivity of 89% and a specificity of 96%: asymmetric pigmented follicular openings, dark rhomboidal structures, slate gray dots, and slate gray globules. A biopsy is warranted when dermoscopic examination reveals a grayish coloring. For a flat pigmented lesion acquired in adulthood, a histopathological diagnosis of "atypical junctional nevus" is not to be accepted uncritically. LM and LMM can also appear in sites other than the face, and dermoscopy can facilitate their recognition. Dermoscopy is an essential tool for physical examination.

Itraconazole in pityriasis versicolor: ultrastructural changes in Malassezia furfur produced during treatment.

Twenty-eight patients with pityriasis versicolor were treated orally with 200 mg of itraconazole per day in an open, randomized comparison of five-day and seven-day treatment regimens. The morphologic changes in Malassezia furfur produced by treatment were confirmed by studies with transmission and scanning electron microscopy. The clinical results showed that seven days of treatment were more effective than five days. Transmission electron microscopy revealed cytopathic changes in the fungus at the end of treatment, intracellular necrosis being complete within seven to 28 days. Cell-surface alterations detected by scanning electron microscopy developed more slowly--maximal changes were observed 14 days after the beginning of treatment. One patient developed nausea during treatment; no other adverse effects were attributed to the drug.

Oral treatment of paracoccidioidomycosis and histoplasmosis with itraconazole in humans.

Twenty-five patients with paracoccidioidomycosis and 17 patients with histoplasmosis were treated with itraconazole. All patients were adults. Those with paracoccidioidomycosis exhibited the chronic disseminated form of the disease; 21 of these patients had lesions in two or more locations, and four had lesions only on the larynx or mouth. Itraconazole was administered at a daily dosage of 50 mg for six months in the majority of these cases. All infections were clinically cured or showed striking improvement. Patients with histoplasmosis had the chronic pulmonary or chronic disseminated form of the disease. A daily dose of 100 mg was administered until clinical cure was established; the dose was then changed to 50 mg until the completion of six months of treatment. Twelve infections were clinically cured; four were strikingly alleviated. The remaining patient, who discontinued treatment with itraconazole after two months, had a severe relapse and died of respiratory failure.

Chronic benign familial pemphigus.

Ten patients with benign familial chronic pemphigus (BFCP) (Hailey-Hailey disease) were evaluated; semiologic and localization differences were described, and special attention was given to solitary or atypical forms. In all the cases, the diagnosis was confirmed by histopathology; some histopathologic differences and the results achieved by direct immunofluorescence of skin are discussed. Most of the patients responded to the treatment with corticosteroids and antibiotics.

Cutaneous ulcers due to Candida albicans in an immunocompromised patient--response to therapy with itraconazole.

The patient, a 68-year-old female, with chronic anaemia and a previous history of carcinoma of the breast treated surgically, had been receiving therapy with methyl prednisone, in addition to gold, for pemphigus vulgaris. She developed deep cutaneous ulcers on the lower leg. All had well-defined edges and were covered with purulent and serosanguinous exudates. On histopathology the ulcers were deeply infiltrated with yeasts and mycelium and Candida albicans was isolated on culture. There was no evidence of systemic candidosis. Complete healing was obtained using itraconazole in a dose of 200 mg daily for 45 days: treatment with prednisone was continued throughout. The response to antifungal therapy alone suggests that Candida was largely, if not wholly responsible, for this unusual clinical condition.

Ultra-short topical treatment of pityriasis versicolor with 2.5% bifonazole cream.

The therapeutic efficacy of a preparation containing 2.5% bifonazole was investigated by comparing three different treatment modalities--A, B, and C. Group A used bifonazole only on Days 1, 2 and 3, and the Group C on Days 1, 3 and 5. Of the patients in Group A 56% had a negative mycological examination at the end of the study. The results obtained in Groups B and C were not significantly different: 92% of the patients had a negative mycological examination at the end of the study. Electron microscope (EM) studies showed morphological alterations such as loss of cytoplasmic organization with shrinkage and folding of the cell membranes after 1 week of treatment only in Groups B and C. We conclude that 2.5% bifonazole is a highly effective treatment for Pityrosporum ovale infection when applied using a 3-day schedule.

Treatment of tinea pedis interdigitalis with bifonazole, 1% gel.

329 adult patients with tinea pedis interdigitalis, which clinical diagnosis was confirmed by positive direct microscopic examinations and cultures of organisms from the lesions, were enrolled in this open and multicentric study. Informed consent was requested and obtained in each case. The bifonazole, 1% gel, tested was applied topically once daily for 3 weeks. Weekly clinical controls were performed during the treatment period and, at least, two clinical mycological posttreatment assessments were carried out. The evaluation criteria were based on the clinical and mycological findings at the end of the second posttreatment week. According to these criteria, the results obtained were: very good (clinical cure, negative mycology) 276 (84.0%); good (clinical improvement, negative mycology) 32 (9.5%); moderate (clinical improvement, positive mycology) 20 (6.0%), and failure (no clinical and mycological changes) 1 (0.5%). Tolerance was excellent, side effects were not observed in any case.

Prophylaxis of tinea pedis interdigitalis with bifonazole, 1% powder.

With the objectives of determining the effectiveness of bifonazole 1% powder in the prophylactic treatment of tinea pedis interdigitalis and its local tolerance, 200 patients who achieved clinical and mycological cure in another previous trial with bifonazole 1% gel, and who were also reliable in the compliance of the treatment, were included in this study. Informed consent was requested and obtained in each case. This was a multicenter, double-blind, controlled and comparative study of one group (100 patients) treated with bifonazole verum against another group (100 patients) treated with bifonazole placebo. The allocation to each group was performed by randomization. Bifonazole was applied once daily in the morning on both feet, after showering, and inside shoes; patients applied it again when changing shoes or socks during the day. Treatment lasted up to 6 months. During the treatment, patients were clinically and mycologically assessed once a month and, if it was necessary, when signs and/or symptoms of infection reappeared. The evaluation criteria were based on the reinfection, clinically and mycologically demonstrable, during the treatment. 29 patients abandoned the treatment. Reinfection was observed in 57 out of the 171 patients who finished the treatment, 47 reinfections occurred in the placebo group and the remaining 10 in the verum group. Tolerance was excellent, no side effects were observed in any patient.