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Background: Biologic disease modifying drugs (bDMARDs) are highly effective treatments of IA such as rheumatoid arthritis (RA) and axial or peripheral spondyloarthritis (SpA). However, they lead to risks of infections and other side effects. Some of these adverse events may be prevented by patient education (PE) aimed at promoting patients’ safety skills. Objectives: To investigate the effect of a nurse-led PE on safety skills of patients with IA at the introduction of a first subcutaneous bDMARD. Methods: Multicentric randomized controlled trial comparing an intervention group (IG) to usual care (UC) at the time of the introduction of a first bDMARD. Inclusion criteria: patients with RA or SpA, biologic naive, eligible for a subcutaneous bDMARD according to the rheumatologist’s opinion. Intervention: a face-to-face nurse-led PE at baseline (BL) and 3 months later, ie, assessment by the nurse of the patients’ health beliefs and educational needs, education focused on safety skills, self-injections and motivation. The primary outcome was the acquisition of safety skills at 6 months measured by the Biosecure Questionnaire (0-100 scale), a 55 item validated questionnaire assessing competences to deal with fever, infections, vaccination, and other daily life situations (ref). The secondary outcomes were quality of life, severe infections rate, coping, psychological well-being and disease activity. Data were anaysed as intent-to-treat using multiple imputations. Results: 128 patients were included from 9 rheumatology departments between January 2017 and April 2018, 39 (30.7%) with RA, 72 (56.7%) with axial SpA, 16 (12.6%) with peripheral SpA; mean age 47.0 ±12.8 years, mean disease duration 6.1 ±7.5 years, 120 (94%) completed the study. BL mean self- reported information on RA treatments (0-10 numeric scale) was similar: 7.1±2.0 in IG; 6.8±2.1 in CG. The mean duration of the intervention was 65.5 ±17.9 minutes. The primary outcome was met: the Biosecure score at 6 months was 81.2 ±13.1 versus 75.6±13.0 in the IG and CG respectively (p =0.016), showing better skills in the IG. Secondary outcomes were also favorable. Conclusion: Safety is an important issue in the management of IA treated with bDMARDs. In this trial, a nurse-led patient education was shown for the first time to be effective in teaching patients the essential safety skills. References [1] Gossec, et al. Joint Bone Spine 2013;80:471-6. Acknowledgement: Grants : The “France Rhumatisme” Foundation and the therapeutic patient education Section of the French Society of Rheumatology. Disclosure of Interests: Catherine Beauvais: None declared, Francoise Fayet: None declared, Alexandra Rousseau: None declared, Christelle Sordet: None declared, Sophie Pouplin: None declared, Yves Maugars: None declared, Rose Marie Poilverd: None declared, Carine SAVEL: None declared, Veronique Segard: None declared, Beatrice Godon: None declared, Christian L’amour: None declared, Aleth Perdriger: None declared, Fabienne Brin: None declared, Patricia Peyrard: None declared, Fabienne Chalier: None declared, Beatrice Pallot Prades: None declared, Isabelle Griffoul: None declared, Laure Gossec Grant/research support from: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Sanofi, and UCB, Consultant for: AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, MSD, Nordic Pharma, Novartis-Sandoz, Pfizer, Roche, Sanofi, and UCB, Consultant for: L Gossec has received honoraria from Celgene as investigator for this study |
