scholarly journals AB0640 LONG-TERM EFFECTIVENESS AND DRUG SURVIVAL OF GOLIMUMAB IN PATIENTS AFFECTED BY PSORIATIC ARTHRITIS WITH CUTANEOUS INVOLVEMENT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1614.1-1615
Author(s):  
G. L. Fonti ◽  
M. S. Chimenti ◽  
A. D’antonio ◽  
M. Teoli ◽  
F. Caso ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Smoking Habit ◽  
Survival Rates ◽  
Real Life ◽  
Peripheral Arthritis ◽  
Cutaneous Manifestations ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Tnf Α ◽  
Joint Symptoms

Background:Psoriatic arthritis (PsA) is a chronic immune-mediated disease associated with psoriasis (PsO). Overexpression of inflammatory cytokines such as tumor necrosis factor (TNF)-α plays a key role in the pathogenic mechanisms. Golimumab (GLM) is a fully human monoclonal antibody IgG1k neutralizing TNF-α approved for PsA and PsO, but effectiveness evaluation in real life remains a crucial issue.Objectives:In a real-life setting, to determine the survival rate of GLM (drug survival) at 48 months in the global population, in different clinical settings, and the effectiveness of GLM in improving joint symptoms and cutaneous manifestations in patients affected by moderate to severe PsA with cutaneous involvement.Methods:We collected retrospectively from 1 January 2014 to 31 December 2019 data from 105 patients affected by PsA, according to the Classification for Psoriatic Arthritis (CASPAR) criteria, who started treatment with GLM. Inclusion criteria were age > 18 years and had a diagnosis of PsA > 6 months, the presence of peripheral arthritis (at least one active joint) and active PsO. Relevant anamnestic, clinical, biochemical data and biological treatment line were collected at baseline (T0) and after 6 (T6), 12 (T12), 24 (T24) and 48 (T48) months of GLM treatment. Comparisons between baseline and 48 months continuous variables were performed using a paired t-test or a Wilcoxon signed-rank test for paired samples. The drug survival rates were analyzed using Kaplan-Meier estimates. Drug survival rates were read from the Kaplan-Meier survival curves. Differences in drug survival between groups were analyzed using a log-rank (Mantel-Cox) test, by stratifying for sex, BMI, smoking habit and line of treatment. A p-value <0.05 was considered as statistically significant.Results:Peripheral arthritis was present in 67 (63.8%) cases, axial disease in 37 (35.3%), enthesitis and PsO as prominent manifestations in 82 (78%) and 84 (80%) patients respectively. Erosive disease was present in 38 (36.2%) of patients at baseline. The most frequent comorbidities were MetS described in 20 (19%) patients and cardiovascular disease described in 33 (31.4%) patients, probably due to the high incidence of smokers (33 (31.4%) of patients) and to the elevate BMI score (27.1±6.0). At 48 months, the 42% (44 of 105) (figure 1A) of the patients have discontinued therapy; the most frequent reason was insufficient response/loss of efficacy (30 patients (28.6%) out of 105). Unexpectedly, no statistical significant difference emerged according to gender (p=0.652), BMI (p=0.655), smoking habit (p=0.466) and line of treatment (p=0.208) (figure 1B-E). Finally, the effectiveness of GLM in improving joint symptoms and cutaneous manifestations was confirmed once again, with a statistical significant improvement at 48 months in clinical (BASDAI p<0.0001; PASI p<0.01; DAPSA p<0.0001) and biochemical (CRP<0.05) data.Conclusion:This multicentric study revealed a high drug persistence of GLM in real-life patients, although the presence of comorbidities. Unlike what is known in literature, our study population presented no differences in terms of clinical response and efficacy between male and female, smokers and no-smokers, obese and health-weight patients, different line of treatment. On the other hand, efficacy and safety of GLM has been demonstrated once again also in real-life treatments.References:No references.Disclosure of Interests:giulia lavinia fonti: None declared, Maria Sole Chimenti: None declared, Arianna D’Antonio: None declared, miriam teoli: None declared, Francesco Caso: None declared, Luisa Costa: None declared, marco tasso: None declared, Augusta Ortolan: None declared, Mariagrazia Lorenzin: None declared, Paola Conigliaro: None declared, paola triggianese: None declared, Raffaele Scarpa: None declared, Roberto Perricone: None declared, Roberta Ramonda Speakers bureau: Novartis, Celgene, Janssen, Pfizer, Abbvie, Lilly

scholarly journals Long-term effectiveness and drug survival of golimumab in patients affected by psoriatic arthritis with cutaneous involvement

2021 ◽  
Author(s):  
Maria Sole Chimenti ◽  
Paola Conigliaro ◽  
Francesco Caso ◽  
Luisa Costa ◽  
Augusta Ortolan ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Smoking Habit ◽  
Survival Rates ◽  
Real Life ◽  
Wilcoxon Test ◽  
Cutaneous Manifestations ◽  
Drug Survival ◽  
Real Life Setting ◽  
Insufficient Response

Abstract Objectives To determine the effectiveness of golimumab (GLM) in improving joint, periarticular structures and cutaneous manifestations in patients with moderate to severe psoriatic arthritis (PsA) with cutaneous psoriasis in different real-life clinical settings and 48-month drug survival. Methods Clinical and laboratory records were collected from PsA patients treated with GLM at baseline (T0) and after 6, 12, 24, 36, and 48 months of treatment. Comparisons were performed using a paired t-test or Wilcoxon test. Drug survival rates were analyzed using Kaplan–Meier estimates. p value < 0.05 was considered statistically significant. Results Data from 105 patients were collected. PsO occurred in 80% of patients and enthesitis in 78%, peripheral and axial arthritis in 63.8% and 35.3%, respectively, while erosions in 36.2%. The main comorbidities were cardiovascular diseases (31.4%) and metabolic syndrome (MetS) (19%). A statistically significant improvement in articular and cutaneous psoriasis was registered at T48 of GLM-therapy in clinical (DAPSA p < 0.0001; PASI p < 0.01; BASDAI p < 0.0001) and laboratory (CRP < 0.05) indexes. Gender (p = 0.652), BMI (p = 0.655), smoking habit (p = 0.466), and line of treatment (p = 0.208) did not affect treatment efficacy nor persistence. At T48, 42% of patients discontinued GLM: the most frequent reason was an insufficient response or loss of efficacy (28.6%). Conclusion A 48-month GLM high drug persistence of PsA patients was observed in real-life, in patients presenting high disease activity, elevated prevalence of comorbidities, and more than one line of treatment at baseline. Patients’ characteristics as gender, smoke, BMI, different lines of treatment, and concomitant methotrexate treatment affected treatment persistence, making GLM effective and safe in moderate-severe PsA in a long-term real-life setting. Key Points• Golimumab was effective in psoriatic arthritis, including both musculoskeletal and cutaneous manifestations. • Golimumab effectiveness and drug survival were not affected by comorbidities and patient-related characteristics. • The 4-year drug survival curves confirm the efficacy and safety of golimumab in psoriatic arthritis patients in a real-life setting.

Two-year survival rates of anti-TNF-α therapy in psoriatic arthritis (PsA) patients with either polyarticular or oligoarticular PsA

2015 ◽  
Vol 44 (3) ◽  
pp. 192-199 ◽  
Author(s):  
F Iannone ◽  
S Lopriore ◽  
R Bucci ◽  
C Scioscia ◽  
MG Anelli ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Survival Rates ◽  
Tnf Α

Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

2016 ◽  
Vol 51 (5) ◽  
pp. 388-393 ◽  
Author(s):  
María Henar García-Lagunar ◽  
María Rocío Gutiérrez-Cívicos ◽  
María Sergia García-Simón ◽  
Pablo Conesa-Zamora ◽  
Enrique Jimenez-Santos ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Effects ◽  
Dosage Regimen ◽  
Survival Rates ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Tnfα Inhibitors ◽  
Treatment Objective ◽  
Factor Α

Background: The introduction of anti–tumor necrosis factor α (anti-TNFα) drugs has improved the clinical outcomes in rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, these drugs may cause adverse effects that motivate a change in or discontinuation of the treatment. Objective: To evaluate the causes of discontinuation or changes in the dosage regimen in a cohort of patients with RA and AS treated with infliximab, adalimumab, etanercept, and golimumab under clinical practice conditions. Methods: This was a retrospective observational study that included patients with RA or AS treated with anti-TNFα drugs between 2008 and 2013. Changes in the dosage regimen, reasons for treatment discontinuation, and adverse effects were recorded and analyzed. Time to discontinuation was estimated using Kaplan-Meier survival analysis. Results: A total of 123 patients with RA and 93 patients with AS were treated with anti-TNFα therapy. During the study, 55.3% of RA patients and 41.7% of AS patients had stopped the treatment. The most frequent changes were modifications in the dosing, and the most frequent adverse effects were reactions after the infusion or injection (53.8% and 66.7% in RA and AS, respectively). Drug survival of etanercept in RA (67.9%) is greater than for adalimumab and infliximab, whereas drug survival of infliximab in AS (70.0%) is greater than for etanercept and adalimumab at 5 years, although there were no significant differences ( P = 0.098 in RA and 0.194 in AS). Conclusions: The main cause of discontinuation of anti-TNFα is therapeutic failure in both diseases. Etanercept and infliximab have the best survival rates in RA and AS, respectively.

Treatment response, drug survival and safety of anti-tumour necrosis factor α therapy in 193 patients with psoriatic arthritis: A twelve-year “real life” experience

2015 ◽  
Vol 82 (1) ◽  
pp. 31-37 ◽  
Author(s):  
Anne-Sophie Soubrier ◽  
Peggy Bele-Philippe ◽  
Bernard Cortet ◽  
Nassima Ramdane-Sebbane ◽  
Marie-Astrid Bacle-Boutry ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Treatment Response ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Life Experience ◽  
Real Life ◽  
Tumour Necrosis Factor Α ◽  
Drug Survival ◽  
Factor Α ◽  
Necrosis Factor

Golimumab in real-life settings: 2 Years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis

2017 ◽  
Vol 47 (1) ◽  
pp. 108-114 ◽  
Author(s):  
Florenzo Iannone ◽  
Leonardo Santo ◽  
Maria Grazia Anelli ◽  
Romano Bucci ◽  
Angelo Semeraro ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Clinical Outcomes ◽  
Real Life ◽  
Drug Survival

scholarly journals AB0740 SECOND-LINE BIOLOGIC DMARDs SURVIVAL IN PSORIATIC ARTHRITIS. DATA FROM A SPANISH THIRD-LEVEL HOSPITAL.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1665.2-1666
Author(s):  
J. Arroyo Palomo ◽  
I. Del Bosque Granero ◽  
A. Corral Bote ◽  
B. A. Blanco Cáceres ◽  
J. Bachiller-Corral
Keyword(s):  
Survival Analysis ◽  
Psoriatic Arthritis ◽  
Second Line ◽  
Hla B27 ◽  
First Line ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Level Hospital ◽  
Necrosis Factor ◽  
Axial Involvement

Background:Psoriatic arthritis (PsA) covers a wide spectrum of disease manifestations, including arthritis, enthesitis, dactylitis and axial spondylitis. This range of symptoms presents a challenge to the treating physician. Biologic disease-modifying antirheumatic drugs (bDMARDs) have proven effective through randomized clinical trials; and most international PsA guides include them as main option upon first-line treatment failure. However, studies regarding drug efficacy after bDMARD switching are scarce, lower response rates and drug survival on consecutive lines has been explored in previous research.Objectives:To assess bDMARDs survival after first-line failure in PsA patients treated in a third-level hospital and to determine baseline clinical and laboratory parameters associated with drug survival.Methods:We conducted a retrospective, single-centre study. 47 patients who received a second-line bDMARD were included, with diagnosis of PsA according to the criteria of an expert rheumatologist. All patients were studied according to a standard protocol. Data regarding bDMARD prescribed, baseline characteristics, axial or peripheral involvement and immunological profile (included both HLA-B27 and HLA-Cw6) were extracted. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at bDMARD start were included, as well. Kaplan-Meier, log-rank analyses and Cox regression models were applied.Results:Of 47 patients receiving a second bDMARD, 55,3% (26) were female and mean (S.D.) age was 40,6 (12,52) years. Median (interquartile range) disease duration was 10,1 (3,7-14,8) years. Prescribed drugs were Adalimumab (ADL) (36,2%, 17), Etanercept (ETN) (27,6%, 13), Infliximab (IFX) (6,4%, 3), Golimumab (GOL) (10,6%, 5), Certolizumab (CTZ) (4,3%, 2), Secukinumab (SCK) (8,5%, 4) and Apremilast (APR) (6,4%, 3). 42,3% cases suffered from axial involvement, rest of the sample (57,6%) presented a pure peripherical form of PsA. HLA-B27 and -Cw6 were assessed in 80,9% (38) and 68,1% (32), respectively; of whom, HLA-B27 carriers were 10,5% and HLA-Cw6 positive, 46,9%. Mean CRP level was 10,25 mg/L and mean ESR was 23,17 mm. Patients showed mean and median global drug retention of 44,57 (29,8-59,3) and 23 months. At 12-month visit, drug survival was 70%, 47% at 24 months, and 33% at 4 years from onset. Mean drug persistence by bDMARD prescribed was: ADL, 62,1 months; ETN, 51,9 months; IFX, 39 months; GOL, 22,8 months; CTZ, 9,5 months; SCK, 13,5 months; and APR, 16,3 months. Through log-rank analyses, differences in drug retention were investigated by several variables. Female sex (30,35m, 16,5-44,2 m.) was identified as statistically significant different than male patients (62,5m, 35,6-89,4m, p=0,021). Although not significant, other differences were remarkable: non-axial involvement, HLA-Cw6 negativity, HLA-B27 positivity and CRP level over 5 mg/L. No differences were found between altered and normal ESR patients.Conclusion:Second-line bDMARD survival is lower in female PsA patients, according to our data and previous bibliography. Despite our reduced sample and possible bias, non-axial involvement, absence of HLA-Cw6, presence of HLA-B27 and higher levels of CRP at biologic onset might be predictors of better drug persistence. Further investigations are required on this field.References:[1]Glintborg B et al. Clinical Response, Drug Survival, and Predictors Thereof Among 548 Patients With Psoriatic Arthritis Who Switched Tumor Necrosis Factor α Inhibitor Therapy. Results from the Danish Nationwide DANBIO Registry. Arthritis Rheum 2013:65(5):1213-23.[2]Stober C et al. Prevalence and predictors of tumour necrosis factor inhibitor persistence in psoriatic arthritis. Rheumatology (Oxford) 2018:57(1):158-163.Table 1. Kaplan–Meier survival analysis of persistence according to sex.Table 2. Kaplan Meier survival analysis of persistence according to HLA-Cw6.Disclosure of Interests:None declared

scholarly journals Polymorphism in Gene for ABCC2 Transporter Predicts Methotrexate Drug Survival in Patients with Psoriasis

Medicina ◽  
2021 ◽  
Vol 57 (10) ◽  
pp. 1050
Author(s):  
Jasna Grželj ◽  
Maruška Marovt ◽  
Pij Marko ◽  
Irena Mlinarič-Raščan ◽  
Tanja Gmeiner ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Cox Regression ◽  
Real Life ◽  
Daily Practice ◽  
Cox Proportional Hazards ◽  
The Novel ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Novel Association ◽  
Drug Treatments

Background and Objectives: Methotrexate is widely prescribed for the treatment of moderate-to-severe psoriasis. As drug survival encompasses efficacy, safety, and treatment satisfaction, such studies provide insights into successful drug treatments in the real-life scenario. The objective was to define methotrexate drug survival and reasons for discontinuation, along with factors associated with drug survival, in a cohort of adult patients with moderate-to-severe plaque psoriasis. Materials and Methods: Data on methotrexate treatment were extracted from our institutional registry. Drug survival was estimated by Kaplan–Meier analysis, and predictors of drug survival were analyzed by Cox proportional hazards regression. Results: We included 133 patients treated with methotrexate. Due to significant effects of the year of treatment initiation, drug survival analysis was performed for 117 patients who started methotrexate in 2010 or later. Median methotrexate drug survival was 11.0 months. Overall, 89% of patients discontinued treatment, with over half of these (51%) due to lack of efficacy. Significantly longer drug survival was seen for patients who discontinued treatment due to lack of efficacy versus drug safety (p = 0.049); when stratified by sex, this remained significant only for women (p = 0.002). The patient ABCC2 rs717620 genotype was significantly associated with drug survival in both univariate log-rank and multivariate Cox regression analyses, with variant T allele associated with longer drug survival (hazard ratio, 0.606; 95% confidence interval, 0.380–0.967; p = 0.036). Conclusions: We have identified the novel association of patient ABCC2 rs717620 genotype with methotrexate drug survival. This pharmacogenetic marker might thus help in the management of psoriasis patients in daily practice.

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