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Barriers to therapy adherence in a group of Italian patients with systemic lupus erythematosus

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

 

  1. Laboratory of Cellular and Molecular Immunology, Department of Interdisciplinary Medicine, University of Bari Medical School, Bari, Italy. elvira.favoino@uniba.it
  2. Laboratory of Cellular and Molecular Immunology, Department of Interdisciplinary Medicine, University of Bari Medical School, Bari, Italy.
  3. Laboratory of Cellular and Molecular Immunology, Department of Interdisciplinary Medicine, University of Bari Medical School, Bari, Italy.
  4. Systemic Lupus Erythematosus Italian Group-ODV, Italy.
  5. Systemic Lupus Erythematosus Italian Group-ODV, Italy.
  6. Internal Medicine Unit, Department of Interdisciplinary Medicine, University of Bari Medical School, Bari, Italy.
  7. Internal Medicine Unit, Department of Interdisciplinary Medicine, University of Bari Medical School, Bari, Italy.
  8. Rheumatology Section, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
  9. Centre for Medical Sciences, University of Trento and Internal Medicine Division, Santa Chiara Hospital, Provincial Health Care Agency (APSS), Trento, Italy.
  10. Clinical and Research Section of Rheumatology and Clinical Immunology, Fondazione Policlinico Campus Bio-Medico, Rome; and Rheumatology and Clinical Immunology, Department of Medicine, University of Rome Campus Biomedico, School of Medicine, Rome, Italy.
  11. Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.
  12. Rheumatology Section, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
  13. Clinical and Research Section of Rheumatology and Clinical Immunology, Fondazione Policlinico Campus Bio-Medico, Rome; and Rheumatology and Clinical Immunology, Department of Medicine, University of Rome Campus Biomedico, School of Medicine, Rome, Italy.
  14. Rheumatic and Systemic Autoimmune Diseases Unit, Department of Interdisciplinary Medicine, University of Bari Medical School, Bari, Italy. federico.perosa@uniba.it

CER19103
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Received: 15/07/2025
Accepted : 10/12/2025
In Press: 06/03/2026

Abstract

OBJECTIVES:
The aim of this cross-sectional study was to investigate the prevalence and associated barriers of non-adherence to therapy (NAT) in a large cohort of Italian patients with SLE.
METHODS:
This multicentre cross-sectional study included 432 adult SLE patients. Adherence to therapy (AT) was assessed through the Medication Adherence Self-Report Inventory (MASRI) and adherence rates <80% were considered non-adherent. Psychological distress was evaluated via the Hospital Anxiety and Depression Scale (HADS). Barriers to AT were identified using a 32-item questionnaire addressing patient-, therapy-, socioeconomic-, and healthcare-related factors. Statistical analyses were performed to identify associations with NAT.
RESULTS:
NAT was observed in 38% of patients and was significantly associated with younger age (p<0.001) and higher HADS scores (p<0.001). Common patient-related barriers included forgetfulness (OR=11.56, p<0.001), daily routine changes (OR=5.29, p<0.001), and perceived hassle (OR=4.85, p<0.001). Key therapy-related barriers included fear (OR=29.15, p<0.001) and suffering (OR=5.73, p<0.001) side effects. Among socioeconomic barriers, only cost concerns were associated with NAT (OR=3.75, p=0.002). Healthcare system-related issues such as long waiting list (OR=2.01, p=0.003), divergent medical opinions (OR=2.10, p=0.001), and prescribed delay (OR=2.36, p=0.004) were more frequent in NAT patients. ROC curve analysis revealed an association between age ≤48 years and the presence of NAT and related behavioural barriers.
CONCLUSIONS:
NAT is prevalent among Italian SLE patients and is driven by a combination of modifiable patient, therapy, and healthcare system barriers. Younger patients are at high risk of NAT due to behavioural and psychosocial barriers. Age-targeted interventions are needed to enhance adherence and outcomes.

Rheumatology Article