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In the single-arm CHRYSALIS trial, advanced non-small cell lung cancer patients harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon 20ins) showed durable responses to amivantamab, an EGFR-MET bispecific antibody targeting tumors with EGFR Exon 20ins. This study compared the effectiveness of amivantamab to real-world systemic anti-cancer therapies in Japan. External control patients were selected by applying CHRYSALIS eligibility to Japanese patients from LC-SCRUM-Asia. External control patients were included for every qualifying line of therapy after platinum-based chemotherapy. Propensity score weighting was applied to external control patients to adjust for differences in baseline characteristics. Outcomes were compared between external control patients, and all and Asian-only CHRYSALIS patients using weighted Cox proportional hazards regression models for progression-free survival (PFS), time to next therapy (TTNT), and overall survival (OS), and generalized estimating equations with repeated measurements for overall response rate (ORR). One hundred fifteen CHRYSALIS and 94 external control patients were identified. Compared to external control patients, amivantamab-treated patients had significantly longer OS (median OS 19.88 vs 14.09 months, HR [95% CI] 0.59 [0.40–0.88]), PFS (median PFS 6.74 vs 4.73 months, HR 0.59 [0.45–0.78]), TTNT (median TTNT 12.16 vs 5.09 months, HR 0.39 [0.29–0.53]), and significantly higher ORR (41.7% vs 14.1%). Analyses of amivantamab-treated Asian patients (n = 61) showed similar clinical benefits. In the absence of clinical evidence from randomized clinical trials, this study reflects the benefit of amivantamab after platinum-based chemotherapy for advanced non-small cell lung cancer patients harboring EGFR Exon 20ins, compared to current real-world therapies. [ABSTRACT FROM AUTHOR]

To assess the correlation between PFS2 and OS among patients with advanced prostate cancer (PC) in a real-world setting for Japan. This was a retrospective analysis using the Japanese MDV database. Patients with nmCRPC (non-metastatic Castration-Resistant PC), mCRPC (metastatic Castration-Resistant PC), and mCNPC (metastatic Castration-Naïve PC) were identified and their medical records were investigated for PFS2 and death. Association between PFS2 and OS was determined using the Pearson's, Spearman's, Kendall's Tau, and Fleischers' correlation coefficients. A total of 386,484 patients with PC were identified from the database, of which, 1,783 patients with nmCRPC, 630 with mCRPC, and 454 with mCNPC met the predefined eligibility criteria. Significant correlation between PFS2 and OS was observed in patients with nmCRPC (Pearson's r = 0.873; 95% CI: 0.849−0.897, Spearman's r = 0.909; 95% CI: 0.893−0.925; Kendall's Tau r = 0.831; 95% CI: 0.812−0.850, Fleischers' r = 0.682; 95% CI: 0.601−0.764), mCRPC (Pearson's r = 0.812; 95% CI: 0.758−0.865, Spearman's r = 0.895; 95% CI: 0.868−0.923, Kendall's Tau r = 0.789; 95% CI: 0.755−0.823, Fleischers' r= 0.439; 95% CI: 0.334−0.544), and mCNPC (Pearson's r = 0.931; 95% CI: 0.899−0.964, Spearman's r = 0.943; 95% CI: 0.922−0.964, Kendall's Tau r = 0.866; 95% CI: 0.836−0.896, Fleischers' r = 0.756; 95% CI: 0.624−0.888). The results of this study indicate a significant correlation between PFS2 and OS, which adds additional evidence to the existing literature of using PFS2 as a surrogate endpoint for OS in patients with PC. [ABSTRACT FROM AUTHOR]

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.)

Aim: Bosentan, ambrisentan, and macitentan are endothelin receptor antagonists (ERAs), currently available in Australia for treatment of pulmonary arterial hypertension (PAH). This study assessed the comparative adherence of these ERAs for PAH in Australian patients., Methods: This retrospective, observational study used data for adults with PAH from the Services Australia 10% Pharmaceuticals Benefits Scheme (PBS) dataset (01/2006-10/2020). The primary outcome was treatment adherence (i.e. receiving ≥80% of ERA doses over 12 months). Secondary outcomes were time to treatment change (add-on or switch) and overall survival., Results: The study included 436 patients who took bosentan ( n  = 200), ambrisentan ( n  = 69), or macitentan ( n  = 167). Treatment adherence was significantly greater in patients who received macitentan (65.3%) versus ambrisentan (56.5%) and bosentan (58.0%), with odds ratios (ORs; 95% CI) of 0.51 (0.30-0.88; p  = 0.016) for bosentan versus macitentan and 0.48 (0.24-0.96; p  = 0.037) for ambrisentan versus macitentan. The median time to treatment change was 47.2 and 43.4 months for bosentan and ambrisentan, respectively (not calculated for macitentan because of insufficient duration of data)., Limitations and Conclusions: Real-world data for Australian patients with PAH showed that treatment adherence for ERAs was suboptimal. Adherence was higher for macitentan compared with ambrisentan and bosentan.

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.)

Background: Psoriasis and psoriatic arthritis (PsA) are included in the group of immune-mediated inflammatory diseases (IMIDs) caused by systemic inflammation; however, indicators for monitoring inflammatory activity in patients with psoriasis, such as the Psoriasis Area and Severity Index (PASI), are limited., Objective: To determine whether the Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire can be used to monitor disease activity in patients with psoriasis., Methods: This was a multicenter, noninterventional, cross-sectional study. Demographic factors and PASI and PASE scores were collected to investigate associations between each., Results: PASE data were available for 1,255 patients, of whom 498 (39.7%) had a score of ≥37. Compared with the group with PASE score <37, the group with score ≥37 had a higher proportion of women (34.9% vs. 48.8%, p <0.0001), older mean age at diagnosis (36.4 vs. 41.7 years, p <0.0001), more severe disease activity using PASI and body surface area measures ( p =0.0021 and p =0.0008, respectively), and higher mean body mass index (23.7 vs. 24.1, p =0.0411). In a multiple linear regression model, PASE score was positively associated with cutaneous disease activity ( p <0.0001)., Conclusion: After risk-adjustment, PASE was positively associated with PASI, which suggests that PASE can be sensitive to disease activity. Since psoriasis is regarded as one of the IMIDs, PASE may be utilized as a tool not only to screen PsA but also to monitor disease activity., Competing Interests: CONFLICTS OF INTEREST: Dae Young Yu and Youngdoe Kim are employees of Janssen Korea. Other authors have no conflict of interest to declare., (Copyright © 2019 The Korean Dermatological Association and The Korean Society for Investigative Dermatology.)

Background/aims: For patients with ankylosing spondylitis (AS), golimumab has consistent efficacy in controlling disease activity over 5 years but its benefit in preventing radiographic progression was less clear at 4 years. To predict radiographic progression, we analyzed the baseline characteristics of AS patients in a Korean population., Methods: Sixty-eight Korean patients with AS participated in the phase 3, multicenter, randomized, placebo-controlled, double-blind trial (GO-RAISE) which has previously been described. Baseline modified stoke AS spine score (mSASSS) and change in mSASSS from baseline (ΔmSASSS) until week 208 were analyzed in the Korean patients enrolled in the GO-RAISE study., Results: Although Korean patients had lower baseline mSASSS compared to non-Korean patients and received active management, radiographic progression was not prevented. Korean patients who did not undergo radiographic progression of spinal lesions of AS were younger and had shorter symptomatic duration, lower Bath AS functional and metrology indices, better chest expansion, and lower baseline mSASSS. The baseline mSASSS and ΔmSASSS were positively correlated in Korean AS patients ( p < 0.001). Radiographic progression was more prevalent (80.0%) when baseline mSASSS > 10 and less common (13.0%) with baseline mSASSS = 0., Conclusions: In Korean AS patients, radiographic progression of the spine after 4 years was predicted effectively by the initial severity of the spinal lesion(s) in patients treated with golimumab.

Background: Psoriasis is an immune-mediated, chronic inflammatory disease affecting multiple aspects of patients' lives. Its epidemiology varies regionally; however, nationwide epidemiologic data on psoriasis depicting profile of Korean patients has not been available to date., Objective: To understand nationwide epidemiologic characteristics and clinical features of adult patients with psoriasis visited university hospitals in Korea., Methods: This multicenter, non-interventional, cross-sectional study recruited 1,278 adult patients with psoriasis across 25 centers in Korea in 2013. Various clinical data including PASI, BSA, DLQI, SF-36 and PASE were collected., Results: A total of 1,260 patients completed the study (male:female=1.47:1). The mean age was 47.0 years with a distribution mostly in the 50s (24.9%). Early onset (<40 years) of psoriasis accounted for 53.9% of patients. The mean disease duration was 109.2 months; mean body mass index was 23.9 kg/m 2 ; and 12.7% of patients had a family history of psoriasis. Plaque and guttate types of psoriasis accounted for 85.8% and 8.4%, respectively. Patients with PASI ≥10 accounted for 24.9%; patients with body surface area ≥10 were 45.9%. Patients with DLQI ≥6 accounted for 78.8%. Between PASI <10 and PASI ≥10 groups, significant difference was noted in age at diagnosis, disease duration, blood pressure, waist circumference of female, and treatment experiences with phototherapy, systemic agents, and biologics., Conclusion: This was the first nationwide epidemiologic study of patients with psoriasis in Korea and provides an overview of the epidemiologic characteristics and clinical profiles of this patient population., Competing Interests: CONFLICTS OF INTEREST: Dr. Hae Jun Song has participated as an advisory board member and has conducted clinical trials for Janssen and has received speaking fees or research support from Janssen. Dr. Chul Jong Park, Dr. Tae Yoon Kim, Dr. Yong Beom Choe, Dr. Seok-Jong Lee, Dr. Nack In Kim, Dr. Jae We Cho, Dr. Jie Hyun Jeon, Dr. Min Soo Jang have no conflict of interest to declare. Dr. Jai Il Youn has conducted clinical trial for Pfizer, Janssen, Lilly, Leo. Dr. Myung Hwa Kim, Dr. Joonsoo Park, Dr. Ki Ho Kim, Dr. Byung Soo Kim have no conflict of interest to declare. Dr. Sang Woong Youn has served as an advisor, received speaker honoraria, and participated in clinical trials for Janssen. Dr. Joo-Heung Lee has no conflict of interest to declare. Dr. Min-Geol Lee has conducted clinical trials for Pfizer, Novartis, Eli Lilly, and Janssen and has received speaking fees from Janssen. Dr. Sung Ku Ahn, Dr. Young Ho Won, Dr. Seok Kweon Yun, Dr. Bong Seok Shin have no conflict of interest to declare. Dr. Seong Jun Seo has conducted clinical trials for Amore, Regeneron, Novartis, Roche. Dr. Ji Yeoun Lee, Dr. Kwang Joong Kim have no conflict of interest to declare. Dr. Young Suck Ro has conducted post-marketing surveillance for Janssen. Mr. Dae Young Yu and Mr. Youngdoe Kim are employee of Janssen Korea. Dr. Jee-Ho Choi has conducted clinical trials for Janssen.