Real-World Experience Using Bimekizumab for the Treatment of Moderate-to-Severe Psoriasis From a Single Outpatient Dermatology Clinic.
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ABSTRACT:
SUBMITTER: Cirone KD
PROVIDER: S-EPMC10908189 | biostudies-literature | 2024 Jan-Feb
REPOSITORIES: biostudies-literature
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Real-World Experience Using Bimekizumab for the Treatment of Moderate-to-Severe Psoriasis From a Single Outpatient Dermatology Clinic.
Cirone Katrina D KD Lovegrove Fiona E FE
Journal of cutaneous medicine and surgery 20231229 1
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Project description:ImportancePalmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules remain challenging to treat. Studies suggest that an interleukin 17 or interleukin 36 loop acts synergistically in these diseases to induce palmoplantar pustules.ObjectiveTo assess the effectiveness of bimekizumab in treating PPP and palmoplantar plaque psoriasis with pustules.Design, setting, and participantsThis case series involved 21 adults with PPP (11 patients) or palmoplantar plaque psoriasis with pustules (10 patients) treated at 1 of 7 tertiary dermatological centers in France from September 2022 through June 2023. All patients treated with bimekizumab for at least 3 months were included in the analyses.Main outcomes and measuresThe main outcome was the posttreatment Investigator Global Assessment (IGA), scored as 0 (complete clearance), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe). When relevant, evolution of joint pain and nail involvement was reported. Tolerance and potential adverse events were noted.ResultsA total of 21 patients (mean [range] age, 46 [24-68] years; 19 females) were included. Eleven patients had isolated PPP, and 10 had palmoplantar plaque psoriasis with pustules. All of them, except 2 who received bimekizumab as first systemic therapy, had not responded to at least 1 systemic treatment (median [range], 3 [1-7] treatments), and/or had adverse events leading to the discontinuation of the treatment. Complete clearance (IGA score, 0) was achieved by 17 patients in 1 to 4 months. Three patients achieved an IGA score of 1, and 1 achieved an IGA score of 2. Three patients with PPP also presented with acrodermatitis continua of Hallopeau. Nail involvement showed 50% to 70% improvement after 4 to 6 months of bimekizumab treatment for these 3 patients. Two patients had SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome; both had complete clearance of skin lesions associated with joint pain improvement. Four patients (19%) with candidiasis were successfully treated with oral antifungal agents. None of the patients had to stop bimekizumab treatment due to adverse events.Conclusions and relevanceThe findings of this case series suggest that bimekizumab could be an appealing approach for treating PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome. Prospective randomized placebo-controlled clinical trials are needed to confirm these encouraging initial results.
| S-EPMC10701662 | biostudies-literature
Project description:BackgroundPsoriasis imposes a significant treatment burden on patients, particularly impacting well-being and quality of life (QoL). The psychosocial impact of psoriasis treatments remains unexplored in most patient populations.ObjectiveTo assess the impact of adalimumab on health-related QoL (HRQoL) in Korean patients with psoriasis.MethodsThis 24-week, multicenter, observational study, assessed HRQoL in Korean patients treated with adalimumab in a real-world setting. Patient-reported outcomes (PROs) including European Quality of Life-5 Dimension scale (EQ-5D), EQ-5D VAS, SF-36, and DLQI were evaluated at week 16 and 24, versus baseline. Patient satisfaction was assessed using TSQM.ResultsAmong 97 enrolled patients, 77 were assessed for treatment effectiveness. Most patients were male (52, 67.5%) and mean age was 45.4 years. Median baseline body surface area and Psoriasis Area and Severity Index (PASI) scores were 15.00 (range 4.00~80.00) and 12.40 (range 2.70~39.40), respectively. Statistically significant improvements in all PROs were observed between baseline and week 24. Mean EQ-5D score improved from 0.88 (standard deviation [SD], 0.14) at baseline to 0.91 (SD, 0.17) at week 24 (p=0.0067). The number of patients with changes in PASI 75, 90, or 100 from baseline to week 16 and 24 were 65 (84.4%), 17 (22.1%), and 1 (1.3%); and 64 (83.1%), 21 (27.3%), and 2 (2.6%), respectively. Overall treatment satisfaction was reported, including effectiveness and convenience. No unexpected safety findings were noted.ConclusionAdalimumab improved QoL and was well-tolerated in Korean patients with moderate to severe psoriasis, as demonstrated in a real-world setting. Clinical trial registration number (clinicaltrials.gov: NCT03099083).
| S-EPMC10112372 | biostudies-literature
Project description:BackgroundBimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, and is a promising drug for patients with moderate-to-severe plaque psoriasis.ObjectivesThis study aimed to assess the efficacy and safety of bimekizumab in treating patients with psoriasis and to determine the optimal maintenance dosing schedules of bimekizumab.Methods and designEligible trials were identified from PubMed, Cochrane Controlled Register of Trials, Embase, ClinicalTrials.gov, and Chinese medical databases. Only double-blind, randomized, active comparator, or placebo-controlled trials of bimekizumab treatment on patients with psoriasis were included in this study.ResultsFive studies were identified, which included 2473 patients with moderate-to-severe plaque psoriasis. The results indicated that bimekizumab had better efficacy than placebo or active comparator for Psoriasis Area and Severity Index (PASI) 90 [risk ratio (RR) = 29.29, 1.52; 95% confidence interval (CI) = 10.30-83.30, 1.06-2.19], PASI 100 (RR = 59.87, 2.06; 95% CI = 15.06-237.99, 1.12-3.79), and Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (RR = 21.55, 1.36; 95% CI = 9.25-50.19, 1.02-1.81). Faster onset of clinically meaningful responses was observed with bimekizumab compared with both active comparators (RR = 2.59; 95% CI = 1.32-5.10) and placebo (RR = 40.46; 95% CI = 13.19-124.13), with PASI 75 response observed at week 4 after one dose. Subgroup analysis showed no significant difference in the reduction of PASI scores between 320 mg q4w dosage and q8w dosage (RR = 1.00; 95% CI = 0.96-1.03). Rates of patients with adverse events (AEs) were comparable in the bimekizumab and active comparator groups (RR = 1.13; 95% CI = 1.01-1.26), and oral candidiasis was one of the most common treatment-emergent AEs.ConclusionThe results of this meta-analysis suggest that bimekizumab is more efficacious and has a rapid onset of action than active comparators and placebo in the treatment of moderate-to-severe plaque psoriasis. After 16 weeks of initial maintenance treatment, both bimekizumab maintenance dosing schedules (320 mg every 4 and 8 weeks) had similar efficacy.
| S-EPMC10084576 | biostudies-literature
Project description:BackgroundReal-world evidence plays a pivotal role in validating the efficacy of biologic drugs beyond the controlled environment of randomized trials. This study aimed to evaluate the effectiveness of tildrakizumab in treating moderate-to-severe psoriasis within a real-world setting over a 52-week period in Portugal.MethodsThis multicentric, prospective, observational study included adult patients with moderate-to-severe psoriasis. All participants received tildrakizumab 100 mg at weeks 0 and 4, followed by a maintenance dose every 12 weeks, and were monitored for 52 weeks. Primary endpoints were determined based on Psoriasis Area and Severity Index (PASI) assessments at baseline, 16 (±2) weeks, 28 (±2) weeks and 52 (±2) weeks.ResultsA total of 54 patients were enrolled in the study (56% men, mean age of 50.3 ± 14.4 years). Half of the sample (n=27) had no prior experience with biologic treatments. About 74% of patients (n=40) presented at least one comorbidity during the study, with psoriatic arthritis being the most prevalent (29.6%). By week 52, there was a significant decrease in the mean PASI from 17.8±10.3 at baseline to 1.3±1.9 (p<0.001), indicating an overall improvement of 93%. By week 52, more than 85% of patients attained PASI ≤5, more than 80% reached PASI ≤3, and nearly 60% achieved PASI ≤1. Infections were observed in 9.3% of patients, and one patient required hospitalization (1.9%). The cumulative proportion of patients continuing treatment at 52 weeks was 88.9%.ConclusionsThis study demonstrates that tildrakizumab is an effective and safe agent for the treatment of moderate-to-severe psoriasis in a diverse, real-world setting.
| S-EPMC10954292 | biostudies-literature
Project description:Bimekizumab, which suppresses both interleukin (IL)-17A and IL-17F, has recently been approved as a biologic for psoriasis. We aimed to evaluate the real-world effectiveness and safety of bimekizumab for psoriasis and to identify predictive factors for its treatment responsiveness. We analyzed 36 Japanese patients with psoriasis (19 with psoriasis vulgaris and 17 with psoriatic arthritis) from May 2022 to September 2023. All patients received bimekizumab (320 mg every 4 weeks) until week 16. Seventeen patients (43.2%) had experienced bio-switch. The median (interquartile range) baseline total psoriasis area and severity index (PASI) was 6 (3.2-20.0). Total PASI rapidly and significantly decreased at week 4 by a median 79.8% from baseline, and gradually decreased thereafter. The PASI on the trunk, and upper and lower limbs rapidly and significantly decreased at week 4 compared to baseline and plateaued thereafter. The neutrophil-to-lymphocyte ratio and neutrophil number significantly decreased at week 16 compared to baseline. At weeks 4, 8, 12, and 16, the achievement rate of absolute PASI ≤2 was 72.2%, 80.6%, 92.9%, and 96.4%, respectively; that of absolute PASI ≤1 was 41.7%, 61.3%, 85.7%, and 82.1%; that of PASI 75 was 55.5%, 52.9%, 69.7%, and 75.8%; that of PASI 90 was 36.1%, 50.0%, 57.6%, and 62.9%; and that of PASI 100 was 19.4%, 38.2%, 51.5%, or 57.6%, respectively. Linear multivariate regression analysis revealed that younger age was associated with a higher percentage reduction of total PASI at weeks 4 and 8. There were no serious or fatal adverse events during treatment. In conclusion, bimekizumab rapidly and remarkably reduced the total PASI together with high achievement rates of absolute PASI ≤1 and ≤2, and with favorable safety in real-world clinical practice. Younger age may be a predictive factor for a good treatment response to bimekizumab.
| S-EPMC11484122 | biostudies-literature
Project description:BackgroundModerate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD.ObjectivesA multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from ≥12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined.MethodsData of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes.ResultsOne hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event.ConclusionsDupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.
| S-EPMC9542087 | biostudies-literature
Project description:IntroductionDose escalation and reduction of biologic treatments are frequent in clinical practice. The aim of this systematic review is to summarise evidence on dose adjustment of biologic treatments for moderate-to-severe plaque psoriasis in the real-world.MethodsA systematic review of real-world evidence on dose adjustment of biologics for plaque psoriasis was performed. Searches were conducted in BIOSIS Previews®, Embase®, International Pharmaceutical Abstracts, MEDLINE®, and SciSearch® in March 2020. Real-world studies that reported biologic dose adjustment for moderate-to-severe plaque psoriasis were included.ResultsThe search identified 162 papers, and 20 studies with 30,912 patients were included from 2014 to 2020. More studies reported on dose escalation than dose reduction. For adalimumab, 3-54% of patients had dose reduction while 0-37% had dose escalation. For infliximab, only two studies reported a dose reduction, with rates of 22-29%, while dose escalation rates varied from 14 to 67%. Dose reduction rates of 5-49% were reported for etanercept while 0-55% of patients had doses escalated. For ustekinumab, dose escalation and reduction rates ranged from 3 to 37% and 7 to 42%, respectively. Two studies reported on dose adjustment for secukinumab; in one 52% of patients initiated on 150 mg instead of the recommended 300 mg, while another reported no dose increase.ConclusionsDose adjustment of biologics for psoriasis is common, with escalation more frequently reported than reduction. Dose escalation may have economic and safety consequences, while dose reduction may impact efficacy. These aspects are important to consider when making decisions on treatment dosing.
| S-EPMC8322248 | biostudies-literature
Project description:Real-world data on gender differences in quality of life among psoriasis patients before and during treatment are scarce. This study analysed data of 748 adults with moderate-to-severe psoriasis enrolled in the Swiss Dermatology Network of Targeted Therapy registry between 2011 and 2023. Quality of life was assessed using the Dermatological Life Quality Index at baseline and at 3, 6, 12, 18, and 24 months. At baseline, women reported significantly lower quality of life than men, with higher Dermatological Life Quality Index scores in the IL-17 inhibitor group (15.0 vs 11.0, p = 0.027), IL-12/23 inhibitor group (7.5 vs 7.0, p = 0.049), and non-biologic therapy group (13.0 vs 9.0, p < 0.001). Although quality of life improved across all subgroups during the follow-up period, women treated with IL-12/23 inhibitors continued to report worse quality of life compared with men after 2 years (p < 0.05), while no significant differences were observed with other therapies. These findings emphasize that women with psoriasis experience lower quality of life at treatment initiation and throughout non-biologic and biologic therapies, underlining the importance of addressing gender-specific differences in the management of psoriasis.
| S-EPMC11833253 | biostudies-literature
Project description:BackgroundReal-world clinical data on psoriasis patients receiving different biological agents is needed, especially in Asian populations.ObjectivesOur aim is to compare and analyze the efficacy and safety profile of four biological agents (etanercept, adalimumab, ustekinumab and secukinumab) in a real-world setting in Taiwan.MethodsWe retrospectively analyzed the clinical data of all patients with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index (PASI) ≥ 10) who received etanercept, adalimumab, ustekinumab or secukinumab between January 2011 and December 2018 in a tertiary hospital in Taiwan.ResultsA total of 119 treatment episodes in 75 patients were included in this study. Ustekinumab was used in 49 treatment episodes, followed by secukinumab in 46 treatment episodes, adalimumab in 14 treatment episodes and etanercept in 10 treatment episodes. The proportion of the biologic-naïve was highest in etanercept (100%) and lowest in secukinumab (23.9%). The PASI-75, -90 and -100 were the highest in secukinumab (91.3%, 82.6%, 41.3%, respectively), followed by ustekinumab (79.6%, 44.9%, 16.3%), adalimumab (64.3%, 28.6%, 7.1%) and etanercept (50.0%, 30.0%, 0%). The rate of adverse events that required treatment was highest for secukinumab (15.2%), followed by adalimumab (14.3%), ustekinumab (8.2%), and etanercept (0%), including 4 cases of infections, 2 cases of cardiovascular diseases and 4 cases of cancers.ConclusionsThis real world data showed differential efficacy and safety of the four biological agents.
| S-EPMC7771674 | biostudies-literature
Project description:IntroductionPsoriasis is a chronic immune-mediated inflammatory skin disease that occurs in 2.5-3.5% of the general population. Infliximab (INF), a TNF-α inhibitor biologic agent, is a long-standing efficacious treatment for psoriasis; however, not all patients sustain a long-term response (LTR) because of a number of factors including antibody production. There is a paucity of studies assessing infliximab efficacy over a period ≥ 5 years.MethodsA retrospective cohort chart review of our clinic patients who had undergone ≥ 5 years of treatment with infliximab for chronic plaque psoriasis was performed. The following variables were recorded and analyzed with the Fisher exact test: age, sex, body mass index ([BMI]; normal weight [NW], overweight [OW], obese [OB]), changes in infliximab strength (dose or frequency), concomitant systemic therapy, and side effects. Clinical improvement was assessed by comparing the total body surface area (tBSA) affected by psoriasis before and after treatment.ResultsThere was a significant difference in likelihood of achieving LTR between the NW, OW and OB groups (p = 0.044). Non-normal-weight patients (OW + OB) were significantly more likely to achieve and sustain LTR than NW patients (OR 9.07, p = 0.020). There were no other significant associations for the other evaluated variables.LimitationsPatients who began treatment with infliximab before 2009 (prior to the use of the clinic's electronic medical record) were excluded. The Psoriasis Area and Severity Index (PASI) was not available for this study.ConclusionSurprisingly, patients who are overweight or obese are more likely to obtain long-term clinical benefit in their psoriasis symptoms with infliximab therapy than patients who are normal weight.
| S-EPMC7477063 | biostudies-literature