PT - JOURNAL ARTICLE AU - Catherine Beauvais AU - Françoise Fayet AU - Alexandra Rousseau AU - Christelle Sordet AU - Sophie Pouplin AU - Yves Maugars AU - Rose Marie Poilverd AU - Carine Savel AU - Véronique Ségard AU - Béatrice Godon AU - Christian L’amour AU - Aleth Perdriger AU - Fabienne Brin AU - Patricia Peyrard AU - Fabienne Chalier AU - Béatrice Pallot-Prades AU - Sophie Tuffet AU - Isabelle Griffoul AU - Laure Gossec TI - Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: a multicentre randomised clinical trial AID - 10.1136/rmdopen-2021-001828 DP - 2022 Mar 01 TA - RMD Open PG - e001828 VI - 8 IP - 1 4099 - http://rmdopen.bmj.com/content/8/1/e001828.short 4100 - http://rmdopen.bmj.com/content/8/1/e001828.full SO - RMD Open2022 Mar 01; 8 AB - Objective To evaluate the effect of a nurse-led patient education on safety skills of patients with inflammatory arthritis treated with biologic disease-modifying antirheumatic drugs (bDMARDs).Methods This is a multicentre, open-labelled, randomised controlled trial comparing an intervention group (face-to-face education by a nurse at baseline and 3 months later) with a control group (usual care) at the introduction of a first subcutaneous bDMARD. The primary outcome was score on the BioSecure questionnaire at 6 months (0–100 scale), a validated questionnaire assessing competencies in dealing with fever, infections, vaccination and daily situations. The secondary outcomes were disease activity, coping, psychological well-being, beliefs about medication, self-efficacy and severe infection rate.Results 129 patients with rheumatoid arthritis and spondyloarthritis were enrolled in nine rheumatology departments; 122 completed the study; 127 were analysed; and 64 received the intervention (mean duration: 65 min at baseline and 44 min at 3 months). The primary outcome was met: the BioSecure score was 81.2±13.1 and 75.6±13.0 in the education and usual care groups (difference: +6.2, 95% CI 1.3 to 11.1, p=0.015), demonstrating higher safety skills in the education group. Exploratory analyses showed better skills regarding infections, greater willingness for vaccinations and greater adherence-related behaviours in the education group. Coping was significantly more improved by education; other secondary outcomes were improved in both groups, with no difference.Conclusions Educating patients was effective in promoting patient behaviours for preventing adverse events with bDMARDs. An education session delivered to patients starting a first bDMARD can be useful to help them self-manage safety issues.Trial registration number NCT02855320.Data are available upon reasonable request by contacting the principal investigator (CB; catherine.beauvais@aphp.fr) and/or the data manager (AR; alexandra.rousseau@aphp.fr). Deidentified participant data will be available upon request by contacting the principal investigator (CB; catherine.beauvais@aphp.fr) and/or the data manager (AR; alexandra.rousseau@aphp.fr). Reuse of data is permitted with a signed data access agreement.