Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

Objectives To evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD).Methods An intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts.Results 45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months.Conclusions A tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars

Cross-sectional study of self-care safety skills in 677 patients on biodrugs for inflammatory joint disease

International audienceRATIONALE:Biodrugs carry specific risks that patients must be aware of and capable of managing. Until now, few studies have addressed the self-care safety skills of patients taking biodrugs. The primary objective of this study was to describe the self-care safety skills of patients taking biodrugs for chronic inflammatory joint disease.METHODS:We conducted a nationwide cross-sectional survey. To obtain the most representative sample possible of patients taking biodrugs, we selected rheumatologists at random from the directory of the French Society for Rheumatology (SFR). Each rheumatologist was to include 5 consecutive patients receiving biodrugs. The BioSecure questionnaire was used to collect information on patient self-care safety skills.RESULTS:Of the 677 included patients, with a mean age of 53 years, 33% were males, 62% had rheumatoid arthritis, and 47% had previously received a therapeutic patient education (TPE) session. The median BioSecure score (percentage of correctly answered items) was 73% (interquartile range, 60-82). The dimensions with the lowest scores were the symptoms requiring a physician visit (median, 75), vaccinations (median, 75), contraception (median, 50), and subcutaneous biodrugs (median, 68). The replies to theoretical items (assessing knowledge) and those to problem-case items (assessing adaptive skills) were discordant.CONCLUSION:This study provides concrete data of use for improving the information and TPE of patients taking biodrugs. Skills regarding the symptoms that require a physician visit, vaccinations, contraception, and subcutaneous treatments need to be improved. Interesting information can be obtained by simultaneously testing knowledge and coping

Étude transversale des compétences de sécurité de 677 patients traités par biomédicament pour un rhumatisme inflammatoire

International audienceRationnelLes biomédicaments présentent des risques spécifiques que les patients doivent connaître et apprendre à gérer. Jusqu’à présent, le niveau des compétences de sécurité des patients sous biomédicament a été peu étudié. L’objectif principal de l’étude était de décrire les compétences de sécurité des patients sous biomédicament au cours des rhumatismes inflammatoires chroniques.MéthodesDesign : enquête nationale transversale. Afin d’être le plus représentatif possible des patients sous biomédicament, les rhumatologues ont été tirés au sort dans l’annuaire de la Société française de rhumatologie. Ils devaient inclure 5 patients consécutifs traités par biomédicament. Les compétences de sécurité ont été recueillies grâce au questionnaire Biosecure.RésultatsParmi les 677 patients inclus, 33 % étaient des hommes, l’âge moyen était de 53 ans, 62 % étaient suivis pour polyarthrite rhumatoïde et 47 % avait déjà bénéficié d’une séance d’éducation thérapeutique (ETP). Le score médian du questionnaire (pourcentage d’items correctement répondus) était de 73 % (interquartile 60–82). Les dimensions dont les scores étaient les moins bons étaient les symptômes devant amener à consulter (médiane 75), les vaccins (médiane 75), la contraception (médiane 50) et les biomédicaments sous-cutanés (médiane 68). Les réponses aux questions théoriques (compétences cognitives) et aux mises en situation (compétences adaptatives) correspondantes n’étaient pas concordantes.ConclusionCette étude apporte des résultats concrets pour améliorer l’information et l’ETP des patients sous biomédicament. Les compétences concernant les symptômes devant faire consulter, les vaccins, la contraception et les traitements sous-cutanées peuvent être améliorées. Il est intéressant de tester à la fois les connaissances théoriques et les mises en situation

Safety of biologics: Elaboration and validation of a questionnaire assessing patients’ self-care safety skills: The BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section

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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

International audienceObjective 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\textendash 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