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

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.

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4393 ◽

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

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OP0160 Response and drug survival of 1st TNF inhibitor in 370 patients with psoriatic arthritis in a real life setting – what is the role of co-medication with methotrexate?:

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2012-eular.1843 ◽

2013 ◽

Vol 71 (Suppl 3) ◽

pp. 108.2-108 ◽

Cited By ~ 1

Author(s):

K.M. Fagerli ◽

E. Lie ◽

D. van der Heijde ◽

M.S. Heiberg ◽

S. Kalstad ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Real Life ◽

Tnf Inhibitor ◽

Drug Survival ◽

Real Life Setting

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Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting

Frontiers in Pharmacology ◽

10.3389/fphar.2019.00965 ◽

2019 ◽

Vol 10 ◽

Cited By ~ 12

Author(s):

Mayara Costa de Camargo ◽

Bruna Cipriano Almeida Barros ◽

Izabela Fulone ◽

Marcus Tolentino Silva ◽

Miriam Sanches do Nascimento Silveira ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Adverse Events ◽

Real Life ◽

Biological Agents ◽

Real Life Setting

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SAT0307 Impact of the modified rheumatic disease comorbidity index(MRDCI) on drug survival of first line anti-tnfΑ drugs in patents affected with psoriatic arthritis in real life setting

10.1136/annrheumdis-2018-eular.2216 ◽

2018 ◽

Author(s):

M. Fornaro ◽

V. Venerito ◽

L. Cantarini ◽

M.G. Anelli ◽

F. Cacciapaglia ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Rheumatic Disease ◽

Real Life ◽

First Line ◽

Drug Survival ◽

Real Life Setting ◽

Comorbidity Index

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Long-Term Retention Rate of Golimumab in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Spondyloarthritis in a Real-Life Setting

JCR Journal of Clinical Rheumatology ◽

10.1097/rhu.0000000000001695 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Belén Serrano-Benavente ◽

Larissa Valor ◽

Tamara del Río Blasco ◽

Iustina Janta ◽

Roberto González Benítez ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Retention Rate ◽

Real Life ◽

Term Retention ◽

Real Life Setting ◽

Long Term Retention

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SAT0423 LONG-TERM SURVIVAL OF THE FIRST BIOLOGIC TREATMENT IN PSORIATIC ARTHRITIS AND THE EFFECT OF THE SELECTED TREATMENT ON DRUG SURVIVAL; TURKBIO REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3909 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1165-1166

Author(s):

S. B. Kocaer ◽

T. Yüce İnel ◽

Y. Erez ◽

A. Köken Avşar ◽

S. Uslu ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Survival Rates ◽

Biologic Agent ◽

Biologic Drugs ◽

Biologic Treatment ◽

Necrosis Factor Alpha ◽

Term Survival ◽

Drug Survival ◽

Significant Difference

Background:Currently, biologic treatments are used effectively in patients with psoriatic arthritis (PsA).Objectives:The aim of this study was to evaluate and compare long-term drug survival of the first biologic treatments including adalimumab, certolizumab, etanercept, golimumab, infliximab, secukinumab and ustekinumab in patients with PsA.Methods:PsA patients, electronically registered at each visit in the TURKBIO database between 2011 and 2019 were included in the study. PASW 18.0 for Windows was used for statistical analysis. Drug survival rates were calculated by Kaplan Meier method.Results:355 patients (227 women; axial PsA = 48, peripheral PsA = 307) were included in the study (Table 1). Adalimumab was the most commonly used first biologic treatment (n=125; 37.6%). The rate of drug survival was found to be 0.75 at month 60 in patients receiving the first biologic treatment (Figure 1). There was no significant difference in drug survival rate between tumor necrosis factor alpha inhibitor (TNFi) and non-TNFi biologic drugs (p=0.56). No difference was also found in drug survival rates between each biologic treatment.Table 1.Initial demographic and clinical datas of patients with PsAPsA Patients (n=355)Females, n (%)227 (63,9)Age of diagnosis, years*34,6 (27-42)CRP baseline*6 mg/ L (3-15)ESR baseline*24 mm/h (10-38)Smoking, n (%)Current99 (28,5)Never192 (55,3)Previous56 (16,2)HLA B27 positivity,n (%)41 (26,4)First biologic agent, n (%)-TNFi332 (95,4)AdalimumabEtanercept125 (37,6)80 (24,1)Golimumab52 (15,6)Certolizumab44 (13,3)Infliximab31 (9,4)- Other biologic agents16 (4,6)Secukinumab13 (81,3)Ustekinumab3 (18,7)*median (min-max)Conclusion:The results of this study establish that more than half of patients with PsA can remain in their initial biologic treatment over a long term. It has been observed that the choice of biologic treatment did not effect the drug survival in PsA.Disclosure of Interests:None declared

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