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The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis. To investigate the efficacy and safety of guselkumab in Korean patients. The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively. Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5 vs. 20.0%, p<.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4 vs. 3.3%, p<.001). At week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7 vs. 66.7%, p<.001; IGA 0: 52.4 vs. 21.2%, p=.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles. The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population. [ABSTRACT FROM AUTHOR]

Postmarketing surveillance is conducted to establish drug safety and effectiveness under real‐world practice. We aimed to validate the effectiveness and safety of ustekinumab in the treatment of adult Korean patients with plaque psoriasis under real‐world practice. This was a prospective, observational, and multi‐center study. Subjects aged 18 years or older who were treated with ustekinumab for plaque psoriasis were enrolled. We enrolled 977 patients; 654 (66.9%) were men, with mean body surface area (BSA, ± standard deviation) of 27.0 ± 18.3% and mean psoriasis area severity index (PASI) score of 18.1 ± 9.7. The effectiveness analysis was performed in 581 patients who had at least one follow‐up assessment and met treatment criteria per local label and reimbursement guidelines. Of these patients, 287 had effectiveness data for visit 6 at 53.7 ± 2.1 weeks. At visit 6, 91.6% (263/287), 51.2% (147/287), and 9.4% (27/287) patients achieved PASI 75, 90, and 100 responses, respectively. Adverse events (AEs) occurred in 112 of the 977 (11.5%) patients with an incidence rate of 21.5 per 100 patient‐years (PYs). Serious AEs occurred in eight (0.8%) patients with an incidence rate of 1.2 per 100 PYs. The estimated 1‐year drug survival rate was 87.7%. The multiple logistic regression analysis showed that higher baseline PASI score and no prior biologic exposure were significant predictors for PASI 90 response at visit 6. Ustekinumab was effective and safe, and displayed a high survival rate in the treatment of adult Korean patients with plaque psoriasis in real‐world practice. [ABSTRACT FROM AUTHOR]

While ustekinumab has been widely used as an effective biologic for the treatment of chronic plaque psoriasis, no prospective studies have specifically investigated the clinical factors that may influence treatment outcomes with ustekinumab. This post-hoc analysis aimed to identify specific clinical factors that may influence treatment outcomes with ustekinumab in psoriasis patients. In the MARCOPOLO study, 102 Korean patients with moderate to severe psoriasis were analyzed to assess the influence of baseline characteristics as clinical factors on clinical response (improvement in Psoriasis Area and Severity Index by ≥75%/90% [ PASI75/ PASI90]) to ustekinumab. In addition, differences in PASI75 and PASI90 responses between the responder group and non-responders were evaluated at weeks 28 and 52. Multiple logistic regression analysis was used to determine adjusted clinical factors predicting treatment outcomes among patient characteristics. At week 28, there was a significant difference in PASI75/ PASI90 response based on prior biologic experience, although the difference did not persist at week 52. In addition, after adjusting for the effects of relevant clinical factors, biologic experience was significantly associated with less PASI75 (odds ratio [ OR] = 0.14, P = 0.001) and PASI90 ( OR = 0.22, P = 0.036) responses at week 28. The presence of comorbidities was higher among non-responders than among PASI75/ PASI90 responders at both weeks 28 and 52, but was not statistically significant. Previous biologic use was the only clinical factor predicting less response at week 28, although it did not influence the clinical response after week 52. Further studies are warranted to investigate the association between presence of comorbidities and clinical response. [ABSTRACT FROM AUTHOR]

Objectives: Real-world evidence regarding prevalence, patient characteristics, and treatment patterns for pulmonary arterial hypertension (PAH) related to systemic lupus erythematosus (SLE) in Japan is limited., Methods: We conducted a retrospective study analysing Japan's Medical Data Vision database from April 2008 to September 2020. Prevalence, incidence, patient characteristics, treatment patterns, and use of vasodilators by treatment line were evaluated., Results: The prevalence of PAH was 0.392% in SLE patients (n = 114/29,077). Cumulative incidence was 0.53% (3 years) and 0.77% (5 years). Of 114 SLE-PAH patients, 49% developed PAH <1 year from SLE diagnosis. SLE-PAH patients were predominantly females (88% vs. 72%), had a lower mean age at SLE diagnosis (53 vs. 56 years), and had more severe SLE (61% vs. 25%) than non-PAH-SLE patients. Glucocorticoids (58%) and vasodilators (27%) were preferred first-line monotherapy for SLE-PAH. A combination of glucocorticoids and immunosuppressants (19%) was the predominant first-line combination therapy. Endothelin receptor antagonists (40% and 44%) and nitric oxide analogues (31% and 40%) were dominant first- and second-line vasodilators., Conclusions: SLE-PAH patients were predominantly females, were younger at diagnosis, and had more severe SLE than non-PAH-SLE patients. Most were diagnosed <1 year of SLE diagnosis. In Japan's real-world practice, the initial treatment goal is SLE management, while vasodilators are preferred in advanced diseases, as per the Medical Data Vision database., (© Japan College of Rheumatology 2023. Published by Oxford University Press.)

Background: In psoriasis treatment, not all body regions improve simultaneously after clinical interventions., Objective: This study was aimed at evaluating clinical responses across body regions, which may differentially influence patient treatment plans., Methods: This prospective, observational, and multi-center study was conducted in Koreans who adhered to ustekinumab treatment based on criteria per local label and reimbursement guidelines. A total of 581 were included in this analysis., Results: The mean (±standard deviation) psoriasis area severity index (PASI) score at baseline, age, disease duration, and body surface area (%) were 18.9±9.69, 44.2±13.29 years, 11.3±9.65 years, and 27.8±17.83, respectively. Across the head and neck, upper extremities, trunk, and lower extremities, the correlation between the PASI sub-scores for the upper and lower extremities was the highest (r=0.680). The mean PASI sub-score for the lower extremities was the highest at baseline. PASI90 and PASI100 scores were the highest for the head and neck region, indicating the highest response rates, while those for the lower extremities were consistently low at all visits., Conclusion: We found differences in regional ustekinumab responses, with the lower extremities being the most difficult to treat. These findings should be considered in psoriasis treatment., Competing Interests: CONFLICTS OF INTEREST: Dr. Sang Wook Son has no conflict of interest to declare. Dae Young Yu, Youngdoe Kim, and Dr. YoungJa Lee are employees of Janssen Korea Ltd. Dr. Hyo Hyun Ahn performed phase II clinical trial sponsored by Regeneron, and phase III trial by Novartis, Pfizer, and Galderma. Dr. Yong Hyun Jang served as a speaker or consultant for AbbVie, Eli Lilly, GlaxoSmithKline, LEO Pharma, Janssen, Sanofi Genzyme, and Novartis also performed phase III clinical trials sponsored by Pfizer and Eli Lilly. Dr. Joo Young Roh served as a adviser or investigator for clinical trials for Novratis, Eli-Lilly, Janssen, Abbvie, BMS and Regeneron and Sanofi. Dr. Young Bok Lee served as a speaker for AbbVie, Janssen, Novartis and has engaged or been working as a principal investigator or sub-investigator in number of clinical trials sponsored by Janssen, Novartis, and Sanofi. Dr. Ji Yeoun Lee served as a speaker for Novartis. Dr. Myung Hwa Kim served as a speaker for Novartis and has engaged or been working as a principal investigator or sub-investigator in number of clinical trials sponsored by Eli-Lilly, Janssen, LEO Pharma, Novartis, Abbvie, and Sanofi. Dr. Gyeong-Hun Park and Dr. Hyun-Sun Yoon have no conflict of interest to declare. Dr. Sang Woong Youn served as a speaker for AbbVie, Eli Lilly, Janssen, and Novartis and also performed phase III clinical trials sponsored by AbbVie, BMS, Eli Lilly, Janssen, Novartis and UCB., (Copyright © The Korean Dermatological Association and The Korean Society for Investigative Dermatology.)