Psoriasis Area And Severity Index Research Articles

Safety and effectiveness of guselkumab in Japanese patients with psoriasis: 20-week interim analysis of a postmarketing surveillance study.

A 52-week postmarketing surveillance study was initiated to evaluate the safety and effectiveness of guselkumab, a human anti-interleukin 23 subunit p19 monoclonal antibody, in Japanese patients with psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis, and erythrodermic psoriasis in real-world practice. Here, we report results of the 20-week interim analysis of the ongoing postmarketing surveillance study. Patients who received guselkumab between May 2018 (the date of commercial launch in Japan) and October 2020 were registered in this study. In total, 411 and 245 patients were included in the safety and effectiveness analysis sets, respectively. Adverse drug reactions (ADRs) occurred in 6.6% (27 of 411) and serious ADRs in 2.2% (nine of 411) of patients. The most frequent ADRs by System Organ Class were "Infections and infestations" (2.4%), with nasopharyngitis being the most frequently observed ADR (0.7%). The mean Psoriasis Area Severity Index score decreased from 11.6 at baseline to 6.5 at week 4 and 2.2 at week 20, with improvements achieving statistical significance at each time point. Clinical Global Impression, Dermatology Life Quality Index, and Nail Psoriasis Severity Index outcomesalso showed substantial improvements. Our findings demonstrate that guselkumab is well tolerated and effective in Japanese patients with psoriasis through 20 weeks of treatment in real-world clinical practice, showing significant effectiveness observed as early as 4 weeks. The study was officially registered with the University Hospital Medical Information Network Clinical Trials Registry with the identifier UMIN000032969.

Certolizumab pegol effectiveness, survival and safety in patients with psoriasis: A multicenter retrospective analysis in daily clinical practice by the Spanish Psoriasis Group.

Certolizumab is an Fc-free PEGylated tumor necrosis factor-alpha (TNFα) inhibitor recently approved for the treatment of moderate-to-severe plaque psoriasis, although there is limited real-world evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab. The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate-to-severe plaque psoriasis under real-world conditions. This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting. A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under-response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI [hazard ratio (HR): 1.12 (1.02-1.23); P = 0.023] and a more significant reduction in PASI at Week 12 [HR: 1.16 (1.07-1.27); P < 0.001] and Week 52 [HR: 1.47 (1.11-1.96); P = 0.007] was shown to be significantly related with better survival for the entire follow-up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn. Certolizumab consistently showed high effectiveness and drug survival rates in this real-life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.

Real-World Long-Term Effectiveness of Risankizumab Among Patients with Moderate-to-Severe Psoriasis: Analysis from an International Medical Chart Review (RAPID) Study.

Real-world data on the efficacy of risankizumab (RZB) in clinical moderate-to-severe plaque psoriasis (PsO) are limited. The RAPID study assessed real-world clinical and patient-reported outcomes in RZB-treated PsO patients using data collected from dermatologists in Canada, the Czech Republic, Germany, Japan, and Poland. This ongoing, retrospective chart review collected data from medical records of RZB-treated adults with moderate-to-severe PsO (09/2022-06/2023). Eligible patients received RZB, had ≥ 12months of medical records after RZB initiation (index date), and had Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA), or static Physician's Global Assessment (sPGA) scores ≥ 3months before and up to 18months after the index date. The proportion of patients achieving a clear/almost clear PsO (IGA/sPGA = 0/1), PASI ≤ 1, Dermatology Life Quality Index (DLQI) = 0/1, and a 90%/100% improvement from baseline in PASI as well as the mean changes in PASI, DLQI, itch, and skin pain scores at 12 and 18 months were reported for patients with non-missing assessments at baseline and 12months. Most patients (66.4%) were male, 74.0% were biologic naïve, and 73.0% had scalp PsO. Mean baseline IGA/sPGA was 3.7 ± 0.5, with a mean PASI of 23.3 ± 11.8. After 12months, 86.1% of patients reported IGA/sPGA ≤ 1, and 75.7% achieved PASI90; these further increased to 91.1% and 80.5% at 18months. DLQI, itch, and skin pain scores improved over time. These data demonstrated the durable, real-world effectiveness of RZB in patients with moderate-to-severe PsO through continued improvement in disease and symptom severity over 18months, with most of the patients reporting clear/almost clear skin.

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.

Psoriasis Area and Severity Index and its Correlation with Liver Function Test

Objective: To determine Psoriasis Area and Severity Index score and its association with LFT values in patients of psoriasis. Methodology: This cross-sectional study, was done on patients visiting the skin OPD of LUMHS Jamshoro/Hyderabad. Diagnosed patients of Psoriasis, aged between 18 and 50 years and both genders were included. A 5cc blood sample was collected from each individual to evaluate the LFT. Psoriasis Area and Severity Index (PASI) scores was defined based on the percentage of body surface area affected by psoriasis lesion. All the information was entered and analyzed using SPSS version 26. Results: The mean age of the patients was 44.81±11.10 years. Out of the total 102 patients, 74.5% were male patients and 25.5% were female. The mean duration of psoriasis was 6.46 ± 4.49 years. Out of all 32.4% had mild psoriasis (PASI &lt; 7), 40.2% had moderate psoriasis (PASI 8-12), and 27.5% had severe psoriasis (PASI &gt; 12). Regarding LFT values, 73.5% had elevated alanine transaminase (ALT), 32.4% had elevated aspartate transaminase (AST), 70.6% had elevated alkaline phosphatase (ALP), 68.6% had elevated bilirubin, and 67.6% had elevated gamma-glutamyl transferase (GGT). AST and GGT levels rise significantly linked to PASI (p- &lt;0.05). Conversely, for ALP and Bilirubin levels, there is no significant difference across severity of PASI (p- &gt;0.05). Conclusion: Patients with severe psoriasis exhibit a predisposition to hepatic dysfunction. Study observed abnormalities in liver function tests (LFT) among psoriatic patients, suggesting a potential link to liver disease development.

Identification of the immune repertoire of γδ T-cell receptors in psoriasis.

The γδ Tcells are a subpopulation of Tcells that are abundantly found in the skin and mucous membranes. Their reactivity to self-antigens and ability to secrete various cytokines make them a key component in psoriasis development. Although the correlation between the immune repertoire (IR) of γδ T-cell receptors and the occurrence and severity of psoriasis remains incompletely explored, high-throughput sequencing of γδ Tcells has led to a deeper understanding of IR in psoriasis. This study investigated the differences between γδ Tcells in patients with psoriasis and healthy controls. The γδ Tcells were identified via immunofluorescence staining and a correlation analysis was performed according to the psoriasis area and severity index (PASI) scores. The IR sequencing method was used to detect IR in the γδ T-cell receptors. The findings demonstrated more skin γδ Tcells in patients with psoriasis, which were positively correlated with the PASI score. There were subtle differences in most variable (V), diversity (D) and joining (J) gene segments and VJ/VDJ combination segments between patients with psoriasis and healthy controls. However, a higher diversity of complementarity-determining region 3 (CDR3) was observed in patients with psoriasis. In summary, the IR of skin γδ Tcells was significantly altered in patients with psoriasis, and the diversity in the cell's CDR3 population is a promising biomarker for assessment of psoriasis severity.

Ocular complications in adults with psoriasis: a cross-sectional study in a referral center in Brazil

PurposeThere is limited literature on the ocular manifestations in patients with psoriasis. Therefore, this study aimed to identify the prevalence of and factors associated with ocular manifestations in adults with psoriasis.MethodsThis cross-sectional study included Brazilian adults with psoriasis. The dermatological evaluation included diagnosis, clinical form, Psoriasis Area and Severity Index (PASI) measurement, and location of the lesions. Patients underwent a full ophthalmological examination, including the Schirmer I test, Rose Bengala staining, and tear breakup time tests. The results were analyzed using chi-square and Pearson’s linear correlation tests.ResultsOf the 130 patients assessed, 118 (90.8%) exhibited ocular abnormalities, with meibomian gland dysfunction (MGD) being the most prevalent (59.2%), followed by dry eye disease (DED) (56.2%). A significant correlation was observed between MGD and PASI (p = 0.05), and between MGD and certain treatment modalities. DED was significantly associated with PASI (p < 0.05). Concurrent use of acitretin was identified as an independent predictor of MGD (odds ratio [OR] = 3.5, p < 0.05), whereas PASI was a protective factor against DED (OR = 0.39, p < 0.01).ConclusionGiven the high prevalence of eye disease among individuals with psoriasis, routine ophthalmological assessments are recommended to prevent possible ocular complications.

Association between the severity of hard-to-treat psoriasis and the prevalence of metabolic syndrome: A hospital-based cross-sectional study in Jakarta, Indonesia.

Psoriatic lesions on the scalp, face, intertriginous, genitals, palms/soles, and nails are often delay diagnosed, hard-to-treat, and cause disability. Metabolic syndrome (MetS) is one of the most frequent and significant comorbidities in psoriasis. Many studies have discovered a link between psoriasis and MetS, but none have specifically assessed the hard-to-treat psoriasis in Indonesian population. This is a multicenter study involving four dermatology referral hospitals to investigate the association between psoriasis severity that has hard-to-treat lesions with the prevalence of MetS in Jakarta, Indonesia. Data was collected from April to October 2022. The severity of 84 hard-to-treat psoriasis patients was measured by Psoriasis Area Severity Index (PASI) scores. The participants divided into PASI score >10 (severe) and ≤ 10 (mild-moderate) groups. MetS was identified based on the modified National Cholesterol Education Program Adult Treatment Panel III. MetS was found in 64.3% of patients. Patients with a PASI score>10 had a significantly higher risk of metabolic syndrome compared to those with a score ≤ 10 (78.6% vs 50%, OR 3.667; 95% CI 1.413-9.514; p = 0.006). The prevalence of hypertension (p = 0.028), low levels of high-density lipoprotein (HDL) cholesterol (p = 0.01), mean fasting blood sugar (p = 0.018), and triglyceride levels (p = 0.044) between the two groups differed significantly. This study found most frequent components of MetS were abdominal obesity, decreased levels of HDL cholesterol, hypertension, hyperglycemia, and hypertriglyceridemia respectively. Individuals with severe hard-to-treat psoriasis had a 3.67 times more likely to have MetS rather than the mild-moderate group.

Effectiveness of secukinumab in patients with psoriasis and psoriatic arthritis in a Saudi real-world setting.

Psoriasis (PsO) is an immune-mediated chronic inflammatory disease that results in severe outcomes that impact the patient's quality of life and work productivity. We investigated the effectiveness of secukinumab in patients with chronic plaque psoriasis and psoriatic arthritis (PsA) over a 12-month period. This was a longitudinal, retrospective study of the medical records of 81 patients with psoriasis and/or psoriatic arthritis who had been treated with secukinumab for at least 12 weeks. The Psoriasis Area Severity Index (PASI), Body Surface Area (BSA) percentage, and Dermatology Quality of Life Index (DLQI) among patients with PsO and PsO-PsA showed a statistically significant decrease from baseline over 12 months by approximately 9.86, 19.3%, and 9.7, respectively (p values < 0.001 for each). Moreover, there was a statistically significant decrease in the overall Disease Activity in Psoriatic Arthritis score (DAPSA) by approximately 22.35 from baseline over 12 months of treatment (p < 0.001). Considering the patients who started secukinumab 12 months or more prior to the study cutoff date, the 12-month retention rate was 85%. In a Saudi real-world setting, secukinumab proved to be an efficient medication with high efficacy and retention rates.

Impact of residual skin lesions and previous biologic treatment failure on patient-reported outcomes in patients with psoriasis receiving biologic treatment.

Recent advances in biologic treatments have made clear skin a realistic treatment goal for psoriasis. However, clear skin may not uniformly translate to an absence of impact on patients' quality of life. This retrospective observational study aimed to elucidate the factors influencing patient-reported outcomes in patients with psoriasis who have demonstrated successful clinician-reported outcomes on using biologics. A total of 96 patients who have achieved a ≥75% improvement in Psoriasis Area and Severity Index (PASI) scores with ≥6 months of biologic treatment were included. Their median PASI score was 0.4, with 37.5% having achieved PASI 100 (clear skin). Furthermore, 47.9% reported no impact of psoriasis on their quality of life (Dermatology Life Quality Index [DLQI] score 0 or 1), while 52.1% reported a negative impact (DLQI score ≥2). Notably, 28.1% of the participants had a history of biologic treatment failure, defined as the inability to achieve or sustain a 75% PASI improvement with the previously used biologic agent. Multivariable logistic regression analysis revealed a positive association between achieving PASI 100 and reporting no impact of psoriasis on quality of life (adjusted odds ratio [aOR] 3.88, 95% confidence interval [CI] 1.49-10.91, P = 0.007). Conversely, prior biologic treatment failure was negatively associated with reporting no impact of psoriasis on quality of life (aOR 0.13, 95% CI 0.02-0.65, P = 0.023). Furthermore, among patients with clear skin, those with experience of previous biologic treatment failure reported significantly lower quality of life than those without such experience (P = 0.033). In conclusion, minimal residual skin lesions and prior biologic treatment failure were associated with poorer patient-reported outcomes in patients with psoriasis. Opting for a biologic agent with the highest predicted efficacy, rather than pursuing a "step-up" approach with a higher possibility of treatment failure, may be a more suitable strategy in the biologic treatment of psoriasis.

Impact of Biologic Therapy on Key Cardiovascular Risk Parameters in a Psoriatic Cohort-a Retrospective Review.

Psoriasis is a risk factor for cardiovascular disease. Biologic agents have revolutionised psoriatic skin control. This study aims to assess the change in cardiovascular risk factors in a cohort of patients treated with 1 year of continuous biologic treatment. A retrospective medical record review was conducted of consecutive patients receiving biologic therapy for chronic plaque psoriasis in a single dermatology centre at a major tertiary hospital in Australia. The effect of biologic therapy on psoriasis was assessed using a psoriasis area severity index (PASI). Cardiovascular risk factors included systolic blood pressure (SBP), diastolic BP (DBP), heart rate (HR) and body mass index (BMI). Measurements at baseline and 1-year follow-up were compared using paired t-tests. A total of 106 patients were reviewed with a median age of 44 years, and 63% of the patients were male. At baseline, mean BMI was 30 (SD 7), mean SBP was 129 (SD 17), mean DBP was 81 (SD 9) and mean HR was 82 (SD 14). Over 12months, the PASI was reduced from 17.4 (SD 8.5) to 1.4 (SD 1.7, p < 0.001) indicating skin improvement. There was no significant difference from baseline in SBP (difference 2.3mmHg, 95% CI - 1.4-5.9), DBP (0.6mmHg, 95% CI - 1.2-2.5), BMI (difference - 0.1kg/m2, 95% CI - 0.9-0.7) or HR (difference 1.3, 95% CI - 3.9-6.4). In patients with psoriasis, markers of cardiovascular disease risk did not improve after 1year of biologic therapy despite significant improvements in psoriasis skin severity.

The psoriasis severity, dermatology life quality index and sleep quality: The role of itch intensity and depression

Aim of the studyTo better understand the origin of sleep quality impairment among psoriasis patients, we sought to examine whether the psoriasis severity, health related life quality, itch and depression are significant predictors of sleep disruption; and whether itch intensity and depression are mediators of the relationship between the health- related life quality and sleep problems.Subject or material and methods42 patients diagnosed with chronic plaque psoriasis, (female: 40.5%; mean age=44.48 years; SD=17.57, age range=21-82) completed Polish versions of: the Pittsburgh Sleep Quality Index (PSQI), the Centre for Epidemiological Studies - Depression scale (CES-D). The itch intensity was measured according to the 10-point visual analogue scale (VAS). The Severity of patient’s psoriasis was evaluated by using The Psoriasis Area Severity Index (PASI), health related life quality was assessed using the Dermatology Life Quality Index (DLQI) .ResultsThe stronger the negative effect of psoriasis on patients’ life as measured by Dermatology Life Quality Index, the greater the sleep disturbances.DiscussionThe results confirm that poor health- related quality of life may account for higher sleep ditrubances among psoriasis patients, and suggest that this negative effect reveals itself, through enhancing depression.ConclusionsIt seems that a greater therapeutic focus on health related quality of life in psoriasis patients may lead to an improvement in their sleep quality.

E069 Bimekizumab maintained efficacy responses through 52 weeks in patients with psoriatic arthritis and inadequate response or intolerance to tumour necrosis factor inhibitors who were responders at week 16: results from a phase 3, randomised study

Abstract Background/Aims Psoriatic arthritis (PsA) is a chronic disease affecting multiple domains; however, patients can experience loss of response with long-term therapy. Therefore, maintaining long-term treatment responses is important. Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, demonstrated rapid and clinically meaningful improvements in joint and skin efficacy outcomes to Week 16, vs placebo (PBO), that were sustained to Week 52. The objective of this analysis was to report maintenance of response in joint, skin and composite efficacy outcomes to 52 weeks in BKZ-treated patients with PsA who were Week 16 responders. Methods BE COMPLETE (NCT03896581), a 16-week double-blind phase 3 study, included patients with active PsA who had inadequate response or intolerance to 1-2 TNF inhibitors (TNFi-IR). Patients were randomised 2:1 to subcutaneous BKZ 160 mg every 4 weeks (Q4W) or PBO. Patients completing Week 16 were eligible to enter an open-label extension, BE VITAL (NCT04009499). Maintenance of response is reported as the percentage of BKZ-treated patients who achieved a response at Week 16 and maintained response at Week 52. ACR20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, minimal/very low disease activity (MDA/VLDA) and Disease Activity Index for PsA (DAPSA) remission/low disease activity (REM+LDA; ≤14) and remission (REM; ≤4) responses are presented. Data are reported as observed case (OC) and using non-responder imputation (NRI) or multiple imputation (MI). Treatment-emergent adverse events (TEAEs) to Week 52 are reported for patients who received ≥1 dose of BKZ, including those who entered BE VITAL (PBO/BKZ). Results Overall, 267 pts were randomised to BKZ 160 mg Q4W; 263 (98.5%) and 236 (88.4%) completed Weeks 16 and 52, respectively. Of BKZ-treated pts who were Week 16 responders, ≥80% maintained response across all joint and skin outcomes, as well as MDA and DAPSA REM+LDA. At Week 16, 179 (67.0%), 116 (43.4%), and 71 (26.6%) patients achieved ACR20/50/70, respectively. Over 80% of responders maintained ACR20/50/70 response at Week 52: 81.6%, 80.2%, 83.1% (NRI); 89.6%, 86.1%, 85.5% (OC). Of 176 patients with psoriasis affecting ≥3% body surface area (BSA) at baseline, 145 (82.4%), 121 (68.8%) and 103 (58.5%) achieved PASI75/90/100 at Week 16; 88.3%, 88.4%, 84.5% (NRI); 97.0%, 96.4%, 91.6% (OC) maintained a PASI 75/90/100 response at Week 52. Similar results were observed for composite measures; 118 (44.2%) patients achieved MDA at Week 16; 81.4%/87.3% (NRI/OC) maintained their response at Week 52. High proportions of Week 16 VLDA/DAPSA REM+LDA/DAPSA REM responders also maintained response at Week 52. To Week 52, 243/388 (62.6%) BKZtreated patients reported ≥1 TEAE; 23 (5.9%) reported serious TEAEs. Conclusion BKZ demonstrated robust maintenance of response at Week 52 in TNFi-IR patients with PsA who responded to BKZ treatment at Week 16. The safety profile was consistent with previous reports. Disclosure W.R. Tillett: Consultancies; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Honoraria; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Grants/research support; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Other; Speaking fees AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. J.F. Merola: Consultancies; AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. Other; Investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. Y. Tanaka: Honoraria; AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. Grants/research support; Chugai, Eisai, Mitsubishi-Tanabe and Taisho. Other; Speaking fees from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. E.G. Favalli: Consultancies; AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Other; Speaking fees AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB Pharma. D. McGonagle: Consultancies; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Honoraria; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Celgene, Janssen, Merck, Novartis and Pfizer. D. Thaçi: Consultancies; AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution and UCB Pharma. Grants/research support; AbbVie, LEO Pharma and Novartis. Other; Investigator for AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution and UCB Pharma. J.A. Walsh: Consultancies; AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB Pharma. B. Ink: Shareholder/stock ownership; AbbVie, GSK and UCB Pharma. Other; Employee of UCB Pharma. R. Bajracharya: Shareholder/stock ownership; UCB Pharma. Other; Employee of UCB Pharma. J. Coarse: Shareholder/stock ownership; UCB Pharma. Other; Employee of UCB Pharma. C.T. Ritchlin: Consultancies; AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie.

E067 Bimekizumab maintained efficacy responses through 52 weeks in biologic disease-modifying antirheumatic drugnaïve patients with psoriatic arthritis who were responders at week 16: results from BE OPTIMAL, a phase 3, activereference study

Abstract Background/Aims Given the chronic nature of psoriatic arthritis (PsA), sustaining high levels of disease control with treatment is important. Assessing maintenance of response in patients that achieve treatment targets is of interest as loss of response can occur with long-term therapy. Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated rapid, clinically meaningful joint and skin efficacy responses at Week (Wk) 16 versus placebo (PBO) in patients with PsA; responses were sustained to Wk52. We report the maintenance of response in joint and skin efficacy outcomes to 52 wks in BKZ-treated patients with PsA who responded at Wk16. Methods BE OPTIMAL (NCT03895203), which included a 16-wk double-blind, PBO-controlled period and a 36-wk active treatment-blind period, assessed BKZ in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active PsA. Patients were randomised 3:2:1 to subcutaneous BKZ 160mg every 4 wks (Q4W), PBO or reference (adalimumab 40mg Q2W). At Wk16, PBO patients switched to BKZ 160mg Q4W. Maintenance of response is reported as the percentage of BKZ-treated patients who achieved response at Wk16 and maintained at Wk52. Data are reported for patients randomised to BKZ 160mg Q4W at baseline. Endpoints include American College of Rheumatology (ACR)20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, minimal/very low disease activity (MDA/VLDA) and Disease Activity Index for PSoriatic Arthritis (DAPSA) remission or low disease activity (REM+LDA; ≤14) and remission (REM; ≤4) responses. Wk16 responders are reported using nonresponder imputation (NRI); maintenance of response to Wk52 is reported using NRI and observed case (OC). Treatment-emergent adverse events (TEAEs) to Wk52 are reported for patients who received ≥1 dose of BKZ, including patients randomised to PBO at baseline. Results At baseline, 431 patients were randomised to BKZ 160mg Q4W; 217/431 (50.3%) had psoriasis affecting ≥3% body surface area (BSA). 414/431 (96.1%) completed Wk16; 388 (90.0%) completed Wk52. Most patients who achieved response at Wk16 maintained at Wk52 across a range of joint and skin outcomes. At Wk16, 268 (62.2%)/189 (43.9%)/105 (24.4%) patients achieved ACR20/50/70; responses were maintained at Wk52 by 88.4%/86.8%/82.9% (NRI); 92.9%/91.1%/87.9% (OC). Of 217 patients with psoriasis affecting ≥3% BSA at baseline, 168 (77.4%)/133 (61.3%)/103 (47.5%) achieved PASI75/90/100 at Wk16. Most patients maintained response at Wk52: 88.1%/82.7%/79.6% (NRI); 98.7%/94.0%/89.1% (OC). The same pattern was observed for composite measures of efficacy. 194(45.0%) patients achieved MDA at Wk16; 85.6% (NRI)/90.7% (OC) maintained response at Wk52. At Wk16, 205 (47.6%)/47 (10.9%) achieved DAPSA REM+LDA/DAPSA REM; 85.9%/68.1% maintained response at Wk52. To Wk52, 555/702 (79.1%) BKZ-treated patients reported ≥1 TEAE; 46 (6.6%) reported serious TEAEs. Conclusion With BKZ treatment, most Wk16 responders maintained robust efficacy responses to Wk52 across joint, skin and composite efficacy outcomes. Safety profile of BKZ was consistent with previous reports. Disclosure W.R. Tillett: Consultancies; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Honoraria; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Grants/research support; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer, UCB Pharma. Other; Speaking fees from AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. J.F. Merola: Consultancies; AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. Other; Investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. Y. Tanaka: Honoraria; AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. Grants/research support; Chugai, Mitsubishi-Tanabe and Taisho. Other; Speaking fees from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. E.G. Favalli: Consultancies; AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Other; Speaking fees from AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB Pharma. D. McGonagle: Consultancies; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Honoraria; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Celgene, Janssen, Merck, Novartis and Pfizer. J.A. Walsh: Consultancies; AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB Pharma. D. Thaçi: Consultancies; AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution and UCB Pharma. Grants/research support; AbbVie, LEO Pharma and Novartis. Other; Investigator for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution and UCB Pharma. B. Ink: Shareholder/stock ownership; AbbVie, GSK and UCB Pharma. Other; Employee of UCB Pharma. R. Bajracharya: Shareholder/stock ownership; UCB Pharma. Other; Employee of UCB Pharma. V. Taieb: Shareholder/stock ownership; UCB Pharma. Other; Employee of UCB Pharma. C.T. Ritchlin: Consultancies; AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie.

Insulin Resistance Impairs Biological Agents Response in Moderate-to-Severe Plaque Psoriasis: Insights from a Prospective Cohort Study in China.

Psoriasis and insulin resistance (IR) are closely related, but it remains unclear whether IR affects the treatment of patients with psoriasis. The objective of this study was to investigate whether IR impairs the treatment response to biologic agents in patients with moderate-to-severe plaque psoriasis. This project was based on a prospective cohort study design. Data for this study were collected from the Shanghai Psoriasis Effectiveness Evaluation CoHort (SPEECH), which is a prospective cohort exploring treatment strategies for psoriasis in China. IR was assessed using the triglyceride glucose-body mass index (TyG-BMI). Psoriasis severity was assessed using the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). Multiple logistic regression was used to explore the differences between patients with high and low levels of IR. Subgroup and sensitivity analyses were performed to examine the robustness of the study results. A total of 290 patients were included in the analysis. Based on the median TyG-BMI, the patients were divided into two groups: High and Low. The High group exhibited a higher prevalence of diabetes, higher BMI, fasting blood glucose, and triglyceride compared with the Low group. Further analysis of the treatment efficacy revealed that the High group had lower response rates for PASI 75, PASI 90, and PGA 0/1 after 12 weeks of treatment. In the Low group, 81.94% of patients achieved PASI 75, 58.33% achieved PASI 90, and 75.69% achieved PGA 0/1. However, the proportion of responses at each endpoint was significantly lower in the High group. The impairment in response to PGA 0/1 was more significant in the High group, indicated by lower odd ratios. Subsequent subgroup analysis and sensitivity analysis produced consistent results. IR is associated with lower effectiveness of biologics in patients with psoriasis. [www.chictr.org.cn], identifier [ChiCTR2000036186].

Ultrasound Assessment of Psoriatic Arthritis Patients With Clinically Normal Nails and Evaluation of its Correlation with the Disease Activity: A Case-Control Study.

Nail unit is one of the targets of ultrasound (US) assessment. We aimed to compare ultrasound parameters of clinically normal nail unit in psoriatic arthritis (PsA) patients with healthy controls (HC) and evaluate their correlations with disease activity. This was a cross-sectional study including patients with PsA and matched HC. Tender (TJC) and swollen joint count (SJC), Psoriasis Area and Severity Index (PASI), and Disease Activity in Psoriatic Arthritis (DAPSA) were collected in PsA patients. Patients underwent US assessment of fingernails with a study of morphological changes and measurement of the thickness of nail bed (NBT), nail plate (NPT), and adjacent skin (ST). Correlation between nail unit parameters and disease activity was studied. We evaluated 22 PsA patients (219 nails) and 21 HC (210 nails). Mean DAPSA was 21.56 ± 14.36 and mean PASI was 2.19 ± 3.8. PsA patients had more US morphological changes than HC (16.89 vs 3.33%, P = .03). NPT comparison between identical fingernails of PsA and HC did not reveal significant difference. However, NBT was significantly higher in HC (1.77 vs 2.07 mm, P = .027) as well as ST (2.26 vs 2.59 mm, P = .003). TJC and ST were positively correlated (r = .46, P = .03). No correlation was noted between disease activity scores and NPT, NBT, or ST in PsA patients. In biologic parameters, ESR was negatively correlated with ST (r = -.41, P = .05). Nail bed and adjacent skin US morphological changes were contributive to distinguish psoriatic from healthy nails. Adjacent skin thicknessmeasurement was positively correlated with TJC and ESR, suggesting that it could be used as an indicator of disease activity in PsA.

Efficacy and Safety of Secukinumab in US Patients with Psoriatic Arthritis: A Subgroup Analysis of the Phase 3 FUTURE Studies.

The aim of this work is to evaluate secukinumab vs. placebo in a challenging-to-treat and smaller US patient subpopulation of the international FUTURE 2-5 studies in patients with psoriatic arthritis (PsA). Data were pooled from US patients enrolled in the phase 3 FUTURE 2-5 studies (NCT01752634, NCT01989468, NCT02294227, and NCT02404350). Patients received secukinumab 300 or 150 mg with subcutaneous loading dose, secukinumab 150 mg without subcutaneous loading dose, or placebo. Categorical efficacy and health-related quality-of-life (QoL) outcomes and safety were evaluated at week 16. Subgroup analyses were performed based on tumor necrosis factor inhibitor (TNFi) status and body mass index (BMI). For hypothesis generation, odds ratios (ORs) for American College of Rheumatology (ACR) 20/50/70 and Psoriasis Area and Severity Index (PASI) 75/90/100 responses by treatment were estimated using logistic regression without adjustment for multiple comparisons. Of 2148 international patients originally randomized, 279 US patients were included in this pooled analysis. Mean BMI was > 30 kg/m2 and 55.2% had prior TNFi treatment. ORs for ACR20/50/70 significantly favored patients receiving secukinumab 300 mg and 150 mg with loading dose vs. placebo (P < 0.05), but not those receiving secukinumab 150 mg without loading dose vs. placebo. For PASI75, ORs favored all secukinumab groups over placebo (P < 0.05); for PASI90 and PASI100, only the secukinumab 300-mg group was significantly favored over placebo (P < 0.05). In this challenging sub-population of US patients with PsA, secukinumab provided rapid improvements in disease activity and QoL. Patients with PsA and active psoriasis might benefit more from secukinumab 300mg than 150mg.

A study on tumor necrosis factor-α single nucleotide polymorphisms and psoriasis vulgaris in Vietnam

This study aims to evaluate the association between tumor necrosis factor-α (TNF–α) single nucleotide polymorphisms and psoriasis vulgaris. This cross-sectional study involved 140 Vietnamese patients of Kinh ethnicity diagnosed with psoriasis vulgaris. The diagnosis of psoriasis vulgaris was based on clinical signs and symptoms. We used Sanger sequencing to analyze two SNPs rs1799964 and rs1799724. Data were analyzed by SPSS 25. SNP rs1799964 has the highest rate of TT genotype at 62.1%, more than double the heterozygous TC genotype at 30%, CC genotype has the lowest rate at 7.9%. CC genotype of SNP rs1799724 accounted for 90% and no homozygous genotype TT was detected. No statistically significant association was found between both SNPs and clinical features (p &gt;0.05). The Psoriasis Area and Severity Index (PASI) was significantly lower in patients with variant alleles (P =0.021). Our data show a significant negative association between SNPs variant alleles and disease’s severity. Studies with larger sample sizes and more biochemical indices may help identify reliably predictive markers for these SNPs.

Effectiveness, safety and impact of guselkumab on sexuality and perceived stigmatization in patients with psoriasis in routine clinical practice: Week 28 results from the prospective German multicentre G-EPOSS study.

G-EPOSS is a prospective, non-interventional, German multicentre study of patients with moderate-to-severe plaque psoriasis receiving guselkumab, a therapeutic monoclonal antibody targeting interleukin-23, in a real-world setting. The objective of the study was to evaluate the effectiveness and safety of guselkumab, including its impact on skin, health-related quality of life (HRQoL), sexuality, and perceived stigmatization. Patients (≥18 years old) received guselkumab per routine clinical practice. The primary endpoint was the proportion of patients achieving absolute Psoriasis Area and Severity Index (PASI) ≤ 3 at Week (W)28. Secondary endpoint assessments over 28 weeks included the Nail Psoriasis Severity Index (NAPSI), anogenital Physician's Global Assessment (aPGA), and Dermatology Life Quality Index (DLQI). Sexuality and perceived stigmatization were assessed by patients using the Relationship and Sexuality Scale (RSS) and Perceived Stigmatization Questionnaire (PSQ), respectively. Overall, 293 patients were included in the evaluable set population. Mean age and disease duration were 45.6 and 17.6 years, respectively. At baseline, mean PASI, aPGA and DLQI scores were 15.3, 2.7 and 11.3, respectively. In total, 25.9% of patients had received a prior biologic. Overall, 83.0% of patients achieved PASI ≤ 3, and 56.2%/35.1% achieved PASI ≤ 1/PASI = 0, respectively, at W28. Among those with NAPSI ≥ 1 and aPGA ≥ 1 at baseline, NAPSI = 0 and aPGA = 0 were achieved by 39.2% and 61.1% of patients, respectively, and 61.4% of patients achieved DLQI 0-1 at W28. Improvements were observed over 28 weeks across individual items of the DLQI, RSS and PSQ, indicating improved HRQoL and sex life, and decreased perceived stigmatization. Based on DLQI Question (Q)9, 53.6% of patients experienced sexual difficulties at baseline, which decreased to 12.1% at W28. DLQI Q9 responses were consistent with RSS item responses, highlighting DLQI Q9 as a sentinel for sexual impairment. Guselkumab improved overall skin symptoms and HRQoL in patients with psoriasis and decreased sexual impairment and perceived stigmatization. No new safety signals were observed. CNTO1959PSO4008.

Ultrasonographic and power doppler parameters of nails fail to differentiate between onychodystrophy in patients with psoriasis vulgaris or psoriatic arthritis

BackgroundNail involvement is frequent in patients with psoriasis (Pso) and psoriatic arthritis (PsA) and there is a relationship between nail involvement and inflammation of the enthesis. The main objective of the present study is to describe the ultrasound findings and clinical characteristics of nails from patients with psoriasis and psoriatic arthritis with and without nail dystrophy.MethodsA cross-sectional study including consecutive patients with PsO and PsA was carried out. The study patients were divided into 4 groups, totaling 120 participants. Group 1: patients with psoriasis vulgaris and clinically normal nails; Group 2: patients with psoriasis vulgaris and onychodystrophy; Group 3: patients with psoriatic arthritis and clinically normal nails; Group 4: patients with psoriatic arthritis and onychodystrophy; All patients were submitted to dermatological and rheumatological clinical analysis. Ultrasound examinations was performed by a single examiner, blinded to all clinical data, with ultrasound high resolution, in B-mode or gray-scale (GS), Power Doppler (PD) and Spectral Doppler.ResultsA significant difference was found between the groups regarding the variable Psoriasis Area and Severity Index (PASI) (p = 0.008) and body surface area (BSA) (p = 0.005), with patients with psoriatic arthritis having lower PASI and BSA compared to patients with only cutaneous psoriasis. A positive relationship was found with the average ultrasound thickness of the nail bed and the Nail Psoriasis Severity Index (NAPSI) in correlation analysis (rho = 0.344). When we grouped patients with psoriasis and psoriatic arthritis, there was no significant difference between the cutaneous psoriasis groups and the psoriatic arthritis groups in terms of nail plate GS (p = 0.442), nail bed PD (p = 0.124).ConclusionGreater nail bed thickness indicates early psoriatic nail disease, as confirmed in our study correlating NAPSI with nail bed thickness. Ultrasonography is a low-cost exam, promising in the evaluation, showing that the ultrasound grayscale is consistent with those who have dystrophic nails, but it can’t distinguish psoriasis from psoriatic arthritis, even in those with nail dystrophy.