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.

Keywords: Drug survival; Golimumab; Long-term effectiveness; Psoriasis; Psoriatic arthritis; Real-life.

Fig. 1

A–D Golimumab effectiveness measured by composite clinimetric indexes and PASI score. **p < 0.01; ***p < 0.001; ****p < 0.0001. DAPSA Disease Activity in Psoriatic Arthritis, BASDAI Bath Ankylosing Spondylitis disease activity index, ASDAS-CRP Ankylosing Spondylitis Disease Activity Score-C-reactive protein based, PASI Psoriasis Area Severity Index

Fig. 2

A–D Golimumab effectiveness measured by patient-reported outcomes and inflammatory markers. **p < 0.01; ***p < 0.001; ****p < 0.0001. CRP C-reactive protein, GH global health, pVAS pain-visual analogue scale, HAQ health assessment questionnaire

Fig. 3

A–D. Forty-eight-month retention rate global (A) and according to gender (B), BMI (C), and smoke habit (D). M male, F female; < 25 normal weight, > 25 overweight, > 30 obese

Fig. 4

A–D Forty-eight-month retention rate according to comorbidities (A), gastro-enteric pathologies (B), metabolic dysfunctions (C), and thyroid disease (D). CoM comorbidities, GE gastro-enteric, Met metabolic dysfunctions, Thyr thyroid disease