Calcipotriol/betamethasone aerosol foam (Enstilum) for the topical treatment of psoriasis vulgaris in routine practice in Korea: A prospective, noninterventional, multicenter study of treatment outcomes and patient satisfaction.

An innovative foam formulation for the fixed-dose combination of calcipotriol and betamethasone dipropionate (Cal/BD) has recently become available for the treatment of psoriasis vulgaris. Observational studies of patients treated with Cal/BD foam in routine practice have been conducted in several Western countries, but there are limited data on outcomes in Asian patients. We performed a prospective, open-label, noncomparative, noninterventional study to investigate treatment outcomes and satisfaction in adult patients receiving Cal/BD foam for psoriasis vulgaris in dermatological centers and outpatient clinics in Korea. Data were collected at the time of enrollment (Visit 1) and at a routine clinic visit ~4 weeks later (Visit 2). In total, 218 patients were enrolled, of whom 175 were included in the safety analysis set (58.9% male; mean age ± standard deviation 46.7 ± 15.1 years; use of Cal/BD foam at least once daily 74.3%). Of the safety analysis set, 166 patients had at least mild psoriasis (Investigator Global Assessment [IGA] ≥ 2) and were analyzed for treatment outcomes and satisfaction. Of the 166 patients, 71.7% had mild psoriasis (IGA 2) at baseline. The majority (57.8%) achieved an IGA of 0/1 (clear/almost clear) at Visit 2. The Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) showed significant improvements from Visit 1 to Visit 2 (PASI -2.4 ± 3.0, DLQI -4.5 ± 5.2, both P < 0.0001). Most of the patients were satisfied with the Cal/BD foam treatment; 77.0%, 60.0%, and 73.9% were satisfied in terms of effectiveness, ease of use, and global satisfaction, respectively. In the safety analysis set, adverse events were reported in 13 patients (7.4%). In conclusion, this first Korean real-world study of Cal/BD foam shows improvement of lesions and health-related quality of life after 4 weeks of treatment, with high global satisfaction and good overall tolerability and safety.

A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis.

BACKGROUND: Etanercept, a soluble tumor necrosis factor receptor, and acitretin have been shown to be effective in treating psoriasis. Acitretin is widely used in Korea. However, the combination of etanercept plus acitretin has not been evaluated among Korean patients with psoriasis. The objective of this study was to investigate the efficacy and safety of combination therapy with etanercept and acitretin in patients with moderate to severe plaque psoriasis. METHODS: Sixty patients with psoriasis were randomized to receive etanercept 50 mg twice weekly (BIW) for 12 weeks followed by etanercept 25 mg BIW for 12 weeks (ETN-ETN); etanercept 25 mg BIW plus acitretin 10 mg twice daily (BID) for 24 weeks (ETN-ACT); or acitretin 10 mg BID for 24 weeks (ACT). The primary efficacy measurement was the proportion of patients achieving 75 % improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. Secondary end points included 50 % improvement in PASI (PASI 50) at week 24 and clear/almost-clear by Physician Global Assessment (PGA) at each visit through week 24. RESULTS: The proportions of patients achieving PASI 75, PASI 50, and PGA clear/almost-clear at week 24 in the ETN-ETN (52.4, 71.4, and 52.4 %, respectively) and ETN-ACT groups (57.9, 84.2, and 52.6 %, respectively) were higher than in the ACT group (22.2, 44.4, and 16.7 %, respectively). The incidence of adverse events was similar across all arms. This was an open-label study with a small number of patients. CONCLUSION: In Korean patients with moderate to severe plaque psoriasis, etanercept alone or in combination with acitretin was more effective than acitretin. All treatments were well tolerated throughout the study. TRIAL REGISTRATION: This study was registered on July 7, 2009 at ClinicalTrials.gov, NCT00936065 .

Burden of illness, quality of life, and healthcare utilization among patients with herpes zoster in South Korea: a prospective clinical-epidemiological study.

OBJECTIVES: To assess the herpes zoster (HZ) disease burden, including the severity and duration of HZ-associated pain, its impact on quality of life (QoL), and healthcare resource utilization (HCRU) in a South Korean clinical setting. METHODS: Patients aged ≥50 years were followed prospectively for ≤6 months. Based on the duration of their episode at enrollment, cases were classified as incident (<7 days) or prevalent (≥7 days). HZ pain and discomfort were measured with the HZ Severity of Illness (HZ-SOI) severity-by-duration composite score. RESULTS: One hundred fifty-one patients (69.5% prevalent cases) were enrolled. Prodrome pain was experienced by 68.2% of patients, of whom 95.1% experienced moderate-to-severe pain; post-herpetic neuralgia was experienced by 38.4%. Prevalent disease, higher acute pain, and older age were significant predictors of greater HZ-SOI, while use of antivirals was associated with decreased HZ-SOI. HZ-associated pain was associated with reduced QoL and affected all daily living activities (particularly mood, life enjoyment, general activities, and sleep), resulting in significant HCRU, including primary care doctor, specialist, or physiotherapist consultations, hospitalizations, and emergency department visits. CONCLUSION: Severe morbidity, impaired QoL, and significant HCRU are associated with HZ in South Korea, especially in older patients, supporting the need for early intervention and preventive strategies to reduce the HZ-associated disease burden.

Case of disseminated vesicles of herpes zoster developing one day before the onset of local eruption in a hospitalized immunocompromised patient.

Disseminated herpes zoster is not rare in immunocompromised patient. It is defined as at least 20 lesions in multiple dermatomes that occur within a week of the onset of local eruption. Herein, we report that a case of disseminated vesicles of herpes zoster (HZ) that developed one day before the onset of local eruption in an immunocompromised patient. A 44 year-old Japanese male, who had been in the hospital with acute myelocytic leukemia, developed disseminated hemorrhagic vesicles of 5 to 10 mm in diameter. The next day, grouped vesicles, including hemorrhagic vesicles erupted on the right side of the second to third cervical (C2-C3) dermatomes. At this point, the diagnosis was made as disseminated herpes zoster. The activation of varicella-zoster virus (VZV) is believed to be due to waning of VZV-specific memory T cell responses. In our case, the memory immunity to VZV which had been increased by last episode of HZ might affect on the appearance of skin eruptions.

Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: results from the PEARL trial.

BACKGROUND: The PEARL study showed that the proportion of psoriasis patients achieving the primary endpoint (at least 75% improvement from baseline to week 12 in the Psoriasis Area and Severity Index) was significantly higher in ustekinumab-treated patients compared with placebo. There is a paucity of data regarding the impact of psoriasis and its treatment on health-related quality of life (HRQoL) in Asian patients. OBJECTIVES: To evaluate the effect of ustekinumab on HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis enrolled in the phase III, randomized, double-blind, placebo-controlled PEARL study. METHODS: In the PEARL study, 121 patients were randomized to receive ustekinumab 45 mg at weeks 0, 4, and 16 (n=61) or placebo at weeks 0 and 4 with crossover to ustekinumab at weeks 12 and 16 (n=60). A major secondary endpoint was the change in Dermatology Life Quality Index (DLQI) from baseline at week 12. Other endpoints included the change in individual DLQI domains, proportion of patients achieving DLQI ≤ 1 (no negative effect), and proportion of patients achieving ≥ 5-point reduction in DLQI (clinically meaningful improvement) at week 12. RESULTS: At baseline, psoriasis had a very large effect on HRQoL (average DLQI, 15.7). At week 12, patients treated with ustekinumab 45 mg had significantly greater improvement from baseline in DLQI scores compared with placebo (mean decrease, 11.2 vs 0.5 (P<0.001). Likewise, 32.2% and 1.7% of patients receiving ustekinumab 45 mg and placebo, respectively, achieved a DLQI ≤ 1, and 81.4% and 18.3% achieved ≥ 5-point reduction (both P<0.001 vs placebo). Individual DLQI domains in the ustekinumab group were significantly improved compared with placebo (P<0.001). For ustekinumab-randomized patients, HRQoL improvements were sustained through week 28. Placebo patients who crossed over to ustekinumab experienced similar improvements compared with those randomized to ustekinumab. CONCLUSIONS: Ustekinumab significantly improves HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis.

Morphometric assessment of nuclei in Bowen's disease and bowenoid papulosis.

BACKGROUND: Occasionally, Bowen's disease and bowenoid papulosis cannot be distinguished in microscopic finding. Their clinical presentations are quite different from one another. The purpose of this study was to evaluate the histological differences in Bowen's disease and bowenoid papulosis, by comparing the size and shape of nuclei, using image analysis system. METHODS: We performed morphometric assessment on 13 specimens of Bowen's disease and eight specimens of bowenoid papulosis using an image analysis system, and the following parameters were calculated, such as nuclear contour index (NCI), irregularities of nucleus (IN), form factor (form AR) and circulatory factor (form PE). RESULTS: For NCI, there were significant differences between the Bowen's disease and bowenoid papulosis, and IN also shows significant differences between these two dis-eases, showing that Bowen's disease has more corrugated or indented nucleus contour than bowenoid papulosis. In the parameter of form PE, there were significant differences between the two diseases, indicating that Bowen's disease has more oval-shaped nuclei than bowenoid papulosis. There were no significant differences in form factor between Bowen's disease and bowenoid pupulosis. CONCLUSIONS: Significant differences were found in the morphometric evaluation between Bowen's disease and bowenoid papulosis. The nuclei were larger, more oval and more irregular margins in Bowen's disease than bowenoid papulosis.