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

Maria Sole Chimenti,Francesco Caso,Maria Grazia Lorenzin,Paola Triggianese,Roberta Ramonda,Paola Conigliaro,Augusta Ortolan,Luisa Costa,Marco Tasso,Roberto Perricone,Giulia Lavinia Fonti

doi:10.1007/s10067-021-05874-6

Maria Sole Chimenti, Francesco Caso + Show 9 more

Open Access

https://doi.org/10.1007/s10067-021-05874-6

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Abstract

ObjectivesTo 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.MethodsClinical 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.ResultsData 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%).ConclusionA 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.

Highlights

Psoriatic arthritis (PsA) is a chronic inflammatory disease, belonging to the group of spondyloarthritis (SpA), typically associated with psoriasis (PsO) and characterized by the presence of both articular and periarticular structures involvement [1]
GLM is a TNF inhibitors (TNFi) approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the treatment of active rheumatoid arthritis, active PsA, active ankylosing spondylitis, severe non-radiographic axial SpA, polyarticular juvenile idiopathic arthritis, and moderate to severe active ulcerative colitis [7]
Limited data are available on the effectiveness and safety of GLM in patients affected by both PsO and PsA in bio-naïve and tumor necrosis factor (TNF)-insufficient responders (TNFIR), in particular concerning skin sustained efficacy

Summary

Introduction

Psoriatic arthritis (PsA) is a chronic inflammatory disease, belonging to the group of spondyloarthritis (SpA), typically associated with psoriasis (PsO) and characterized by the presence of both articular and periarticular structures involvement [1]. Etanercept, infliximab, adalimumab, golimumab (GLM), and certolizumab have been demonstrated to be effective in PsA and in distinctive aspects of the disease, as skin disease, peripheral arthritis, enthesitis, and dactylitis. Their effectiveness was demonstrated in improving quality of life and work ability and in reducing radiographic progression [6]. Clinical trials as GO-REVEAL studies demonstrated a satisfactory efficacy of GLM in improving PsA signs and symptoms and in treating the structural damage caused by the disease [8]. Limited data are available on the effectiveness and safety of GLM in patients affected by both PsO and PsA in bio-naïve and TNF-insufficient responders (TNFIR), in particular concerning skin sustained efficacy

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