Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study.

Bimekizumab treatment has demonstrated significant improvements in clinical outcomes in patients with moderate to severe plaque psoriasis; however, studies so far have focused on predominantly White patient populations from North America and Europe, with one smaller study in a Japanese population. Here, clinical responses, safety, and tolerability of bimekizumab treatment in Korean patients are reported. Korean patients with moderate to severe plaque psoriasis were randomized to bimekizumab 320 mg every 4 weeks (Q4W) or placebo Q4W to week 16. Co-primary efficacy end points were achievement of ≥90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) and Investigator's Global Assessment score of 0/1 (clear/almost clear) at week 16. Secondary efficacy end points included achievement of PASI 75 at week 4 and Dermatology Life Quality Index 0/1 at week 16. Safety outcomes were also assessed. Statistical analysis of the co-primary efficacy end points was performed using a type I error rate, at a two-sided α level of 0.05. Overall, 47 Korean patients were randomized to treatment (bimekizumab: 32, placebo: 15). At week 16, bimekizumab-treated patients had significantly higher clinical responses versus placebo-treated patients (PASI 90: 81.3% vs. 0%; IGA 0/1: 87.5% vs. 0%, p < 0.001 for both). Bimekizumab showed a rapid onset of clinical response, with 75.0% of patients achieving PASI 75 by week 4 (0% in placebo patients [nominal p < 0.001]). A higher proportion of bimekizumab-treated patients achieved DLQI 0/1 at week 16 (46.9% vs. 6.7% in placebo patients, nominal p = 0.007), indicating greater improvements in health-related quality of life (HRQoL) following bimekizumab treatment. Bimekizumab was well-tolerated in Korean patients, with no new safety signals identified. Treatment with bimekizumab led to rapid improvements in clinical responses and HRQoL versus placebo in Korean patients, consistent with responses in global populations. These findings suggest that bimekizumab is an effective and well-tolerated treatment option in Korean patients with psoriasis.

Effectiveness of calcipotriol/betamethasone dipropionate aerosol foam in patients with small versus large plaque psoriasis in routine practice in South Korea.

Small plaque psoriasis is the typical form of chronic plaque psoriasis affecting adults in South Korea. The effectiveness of calcipotriol/betamethasone dipropionate (Cal/BD) aerosol foam for large and small psoriasis plaques has not previously been examined. We performed a post hoc analysis of a recent, 4-week observational study of Cal/BD aerosol foam use in routine clinical practice in South Korea. Investigator Global Assessment response ([IGA] 0/1 at week 4), Patient Global Assessment response ([PaGA] 0/1 at week 4), change in Psoriasis Area and Severity Index (PASI), changes in psoriasis symptom scores, change in the Dermatology Life Quality Index (DLQI), and the proportion of patients achieving DLQI ≤5 were analyzed for patients with small (≤5 cm; n = 131) or large (>5 cm; n = 35) baseline plaque size. IGA response rates were similar for patients with small and large plaques (59.5% and 51.4% respectively). Similarly, there was no significant difference between the small and large groups in mean change in PASI (-2.20 vs -3.34), the proportions of patients with DLQI ≤5 (62.3% vs 54.3%) or PaGA 0/1 (29.2% vs 40.0%). Mean improvements in DLQI (-4.04 vs -6.20) and in psoriasis symptoms including itching (-1.50 vs -2.83), sleep loss (-0.67 vs -1.89), dryness (-1.57 vs -2.97), scaling (-1.21 vs -3.57), and redness (-1.17 vs -3.11) were greater in patients with large plaques than those with small plaques. Itching and DLQI differences were not statistically significant after adjustment for baseline characteristics. Stratification by body surface area affected eliminated statistically significant differences between the groups for most outcomes. In conclusion, this analysis suggests that Cal/BD aerosol foam is an effective, well-accepted treatment for adult patients with the small plaques typical of chronic plaque psoriasis in South Korea, as well as for those with large plaques.

A Comprehensive Review of the Acne Grading Scale in 2023.

Acne is a common skin inflammatory condition that can significantly affect the patient's quality of life. Therefore, accurate assessment scales are very important for treatment and management of acne vulgaris. This review article issues a comprehensive review of various acne severity assessment scales. In this text, the authors review the acne grading scales, such as the Pillsbury scale, Cook's acne grading scale, Leeds acne grading system, Global Acne Grading System, and investigator's global assessment, etc. And we delve into the characteristics, advantages, limitations, and applicability of these scales. The acne grading scale to be developed in the future should be objective, accurate, comprehensive, easy to use, and applicable in a variety of clinics and research settings. Current technologies, such as artificial intelligence, could potentially contribute to the development of ideal acne grading scales that meet unmet needs.

Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea.

Background: Secukinumab, a fully human monoclonal antibody, was approved in Korea for the treatment of moderate to severe psoriasis in September 2015. Objectives: To assess the safety and effectiveness of secukinumab in patients with moderate to severe psoriasis in Korea. Design: Multicenter, real-world, noninterventional study conducted over 6 years. Methods: Adults with moderate to severe psoriasis were enrolled. Safety was assessed by evaluating adverse events (AEs), treatment-related AEs, and serious AEs (SAEs). Effectiveness was assessed using the change in absolute Psoriasis Area and Severity Index (PASI) score, percentage of patients achieving PASI 75/90/100 and PASI ⩽2; at weeks 12 and 24. Results: Overall, 829 and 542 patients were included in the safety and effectiveness sets, respectively. AEs, treatment-related AEs, and SAEs occurred in 29.0%, 9.5%, and 4.1% of patients, with incidence rates of 39.43, 12.98, and 5.59 per 100 patient years, respectively. The absolute PASI score decreased from 16.1 ± 7.1 (baseline) to 1.6 ± 2.4 (week 24), with a similar reduction in biologic-naïve (16.4 ± 7.3 to 1.5 ± 2.2) and biologic-experienced (14.8 ± 5.9 to 2.4 ± 3.2) groups. At week 24, PASI 75/90/100 was achieved by 95.1%, 62.4%, and 24.9% of patients. At week 24, PASI 75/90 were higher in biologic-naïve (96.6%/65.8%) than biologic-experienced patients (88.3%/48.6%), whereas PASI 100 was similar in both cohorts (24.1% and 28.6%). A similar trend in PASI ⩽ 2 was observed in both cohorts. Conclusion: Secukinumab showed sustained effectiveness and favorable safety profile in adult patients with moderate to severe psoriasis in Korea.

Review of the reasons for and effectiveness of switching biologics for psoriasis treatment in Korea.

Background Switching of biologics in patients has become common in clinical practice. Objectives This study investigated the reasons for and effectiveness of switching biologic agents during the treatment of psoriasis. Methods We retrospectively reviewed patients with psoriasis who were treated with biologics at Pusan National University Hospital and Chosun University Hospital from March 2012 to June 2020. We assessed their demographics and treatment characteristics (reasons for switching biologics and efficacy of the first- and second biologic agents). Results Of the 162 psoriatic patients treated with biologic agents for more than 52 weeks, 35 required a switch to another biologic agent. The reasons for switching biologic agents were inefficacy (n = 30), adverse events (n = 2) and others (n = 3). The mean psoriasis area and severity index (PASI) score was 12.1 at the start of the second biologic and 3.4 at 14-16 weeks later. Patients were more likely to switch to another biologic agent when they exhibited a high initial psoriasis area and severity index score and concomitant psoriatic arthritis. Limitations As a retrospective study, there were some limitations such as lack of a placebo control group and the time point of 14-16 weeks being somewhat early to judge the effect of the biologics. Conclusions The most common reason for switching biologic agents in Korea was treatment inefficacy, especially secondary failure. Despite the inefficacy of previous biologic agents, switching to a different agent may be an efficacious approach.

Which Areas Are Still Left in Biologics Responsive Korean Patients with Moderate to Severe Plaque Psoriasis.

BACKGROUND: Psoriasis localized to certain body areas, such as the scalp, nails, palms, soles, intertriginous regions, and genital regions, is reportedly difficult to treat. OBJECTIVE: To investigate the biologics-resistant areas in South Korean patients with psoriasis treated with biologics. METHODS: The study included 50 patients with chronic moderate to severe plaque psoriasis from the Pusan National University Hospital and Chosun University Hospital between October 2019 and September 2020. The patients had at least one psoriatic lesion, were treated with biologics for more than six months, and exhibited a partial or good response (reaching a Psoriasis Area and Severity Index [PASI] score of 1~5 after biologics treatment). RESULTS: A total of 50 patients with psoriasis (32 male, mean±standard deviation 47.8±11 years), with a median PASI score of 1.8, were included. The most common biologics-resistant areas were the anterior lower leg (56.0%), followed by the knee (48.0%) and posterior lower leg (42.0%). The proportion of biologics-resistant areas were obtained for body regions traditionally considered as difficult-to-treat entities, including the fingernails (10.0%), toenails (14.0%), scalp (38.0%), palm (12.0%), sole (14.0%), and genital areas (10.0%). CONCLUSION: This study determined the biologics-resistant areas in South Korean patients, successfully treated with biologics, in a real-world clinical setting.

Surgical experiences in pediatric pilomatricoma: punch incision and elliptical excision.

BACKGROUND: As pilomatricoma is a common adnexal skin tumor often occurring in exposed areas, dermatologists focus on minimizing postsurgical scarring. METHODS: This retrospective study included patients aged < 19 years who underwent surgical treatment for pilomatricoma at a single university hospital from 2015 to 2021. Patient demographics, tumor characteristics, and surgical outcomes were analyzed according to the surgical methods including punch incision and elliptical excision. RESULTS: Overall, 75 patients and 79 lesions were included in the study. The mean age of the patients was 8.4 years, and 48 patients (64.0%) were females. The face was the most common site of pilomatricoma (51.9%), and within the face, the cheeks were the most common sites. No recurrence was observed in the elliptical excision group, while one case of recurrence (4.5%) was observed in the punch incision group. The mean length of the wound was 2.00 cm in the elliptical excision group, which was longer than that in the punch incision group (0.49 cm; p < .001). CONCLUSIONS: Considering that surgery is the gold standard treatment for pilomatricoma, punch incision may be useful as an alternative surgical option for pilomatricoma in children.

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 Case of Mucosal Fixed Drug Eruption Caused by Tamsulosin Administration.

Fixed drug eruption (FDE) is a rare type of drug reaction that involves the skin and, less commonly, the mucosal membranes. It is characterized by clinically well-defined erythematous patches or plaques with or without blisters, which relapse at the same location if the causative agent is readministered. Tamsulosin is an alpha-1 adrenergic receptor blocker used to treat benign prostatic hyperplasia, and its common side effects are dizziness and headache. Only one case of cutaneous FDE due to tamsulosin administration has been reported but no other case of mucosal involvement has been reported to date. Therefore, we present a case of mucosal FDE caused by tamsulosin administration along with a literature review.

A Case of Exfoliative Vesiculobullous Prurigo Pigmentosa Cured by Doxycycline and Topical Tacrolimus.

Prurigo pigmentosa is a rare inflammatory skin disease characterized by an unexpected onset of diffuse erythematous papules and macules usually on the chest, neck, and back. These generally resolve, leaving reticular hyperpigmentation. Rarely, vesicular or bullous forms have been reported. We present a case of exfoliative vesiculobullous prurigo pigmentosa in a 13-year-old boy. He presented with symmetrical eruption of papules and vesicles on his back, neck, and chest in the last 10 days, causing pruritis and prickling sensation. Within a few days, the bullous lesions and all affected areas of the skin showed exfoliation. Histological study and clinical findings indicated the condition to be vesiculobullous prurigo pigmentosa with exfoliation. Treatment with doxycycline 200 mg/day and topical tacrolimus ointment showed a good response. The lesions resolved, leaving a light-brown reticulated hyperpigmentation. In conclusion, this was a case of exfoliative vesiculobullous prurigo pigmentosa in an adolescent man successfully treated with doxycycline and topical tacrolimus as an effective and safe treatment option.

Efficacy and safety of brodalumab in the Korean population for the treatment of moderate to severe plaque psoriasis: A randomized, phase III, double-blind, placebo-controlled study.

Psoriasis, a chronic inflammatory skin disease, negatively impacts patients' quality of life (QoL). This randomized, phase III, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of brodalumab, a human anti-interleukin-17 receptor A monoclonal antibody, in Korean patients with moderate to severe plaque psoriasis. Coprimary end-points were the percentage of patients with 75% or more improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (sPGA) success (score 0/1) at week 12. Secondary end-points included the percentage improvement from baseline in PASI score and proportion of patients with PASI 50/75/90/100 responses. QoL was assessed with the Dermatology Life Quality Index (DLQI). Eligible patients were randomized to receive brodalumab 210 mg (N = 40) or placebo (N = 22) every 2 weeks (Q2W) at a 2:1 ratio for 12 weeks. Subsequently, all patients entered an open-label extension phase and received brodalumab 210 mg Q2W until week 62. At week 12, the proportion of patients who achieved the coprimary end-points, PASI 75 and sPGA success, was significantly higher in the brodalumab 210 mg Q2W group compared with the placebo group (92.5% vs 0%). At week 12, the mean ± SD percentage improvement in the PASI score was 96.87 ± 6.01% in the brodalumab 210 mg Q2W group, which was maintained until study end (week 64). PASI 50/75/90 responses were achieved by 100% of patients receiving brodalumab 210 mg Q2W at weeks 6, 13, and 24, respectively; PASI 100 was achieved by 82.8% of patients at week 64. Brodalumab treatment rapidly improved DLQI scores. The most common treatment-emergent adverse events were nasopharyngitis, upper respiratory tract infections, tinea pedis, and urticaria. Overall, treatment with brodalumab 210 mg Q2W resulted in a rapid and significant clinical benefit and was well tolerated in patients with moderate to severe plaque psoriasis in Korea.

Primary Cutaneous Cryptococcosis in an Older Immunocompetent Patient: A Case Report.

Cryptococcus neoformans is an encapsulated yeast that can be found in pigeon droppings, hay, and dust. Primary cutaneous cryptococcosis (PCC) without systemic involvement is recognized as a distinct clinical condition and is rarely reported in immunocompetent patients. A 78-year-old woman with no history of other diseases except for hypertension presented with a painful diffuse erythematous plaque along with oozing on left forearm that had lasted for 7 weeks. She was treated with cefoperazone/sulbactam for 3 weeks under suspicion of bacterial cellulitis, although the lesions aggravated without any improvement. We performed bacterial and fungal cultures as well as incisional biopsy. The pathogen was identified as Cryptococcus neoformans following sequence analysis of the internal transcribed spacer gene. The patient was treated with fluconazole 400 mg/day for 3 months, and there was no evidence of recurrence after 3 months of follow-up.

Two Cases of Aquagenic Wrinkling of the Palms in Korean Healthy Women: Easily Overlooked Disease.

Aquagenic wrinkling of the palms (AWP) is a rare condition, which is characterized by appearance of whitish papules and plaques and an excessive wrinkling and swelling of the palmar skin after exposure to water. Herein, we report two cases of AWP. A 17-year-old woman presented prickling focal various sized whitish papules, plaques with wrinkles on both palms after water contact for 6 months ago. Histologic findings were consistent with AWP. A 26-year-old woman presented asymptomatic multiple various sized whitish papules, plaques with wrinkles on both palms after water contact for 1 year ago. Both patients underwent a cystic fibrosis transmembrane conduct receptor test but were negative and improved without any treatment.