Krystel Aouad1,2, Philippe Gaudin3, Olivier Vittecoq4, Jacques Morel5, Jean-Marie Berthelot6, Eric Senbel7, Thierry Schaeverbeke8, Frédéric Lioté9, René-Marc Flipo10, Alexandrine Pinta11, Francis Guillemin12, Bruno Fautrel1,13. 1. Rheumatology Department, Pitié Salpêtrière hospital, Sorbonne Université - Assistance Publique Hôpitaux de Paris, Paris, France. 2. Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon. 3. Rheumatology Department, Hôpital Sud, A Michallon, Echirolles, France. 4. Rheumatology & CIC-CRB 1404 Department, Rouen University Hospital and Normandie University, UNIROUEN, Rouen, France. 5. Rheumatology Department, CHU and University of Montpellier, Montpellier, France. 6. Rheumatology Department, CHU Nantes, Nantes, France. 7. Rheumatology Department, Sainte Marguerite Hospital, Marseille, France. 8. Rheumatology Department, CHU Bordeaux, Université V Segalen, Bordeaux, France. 9. Rhumatology Department, CHU Lariboisière, Centre Viggo Petersen, Université de Paris-AP-HP, Paris, France. 10. Rheumatology Department, Université de Lille, CHU Lille, Lille, France. 11. ROCHE, Boulogne Billancourt, France. 12. Inserm CIC 1433, Epidémiologie clinique, CHRU Nancy, Nancy, France. 13. Sorbonne University-INSERM, U1136-6, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
Abstract
OBJECTIVE: The Flare Assessment in RA (FLARE-RA) self-administered questionnaire aims to identify patients who had flare in the interval between two consultations. This study aimed to establish a threshold for FLARE-RA score to identify RA flare. METHODS: The Tocilizumab SubCutAneous study evaluated the efficacy and safety of s.c. tocilizumab (TCZ) to patients with active RA. Disease activity was assessed with the DAS28ESR at baseline and at week 2 (W2), W4, W12 and W24. The FLARE-RA questionnaire was administered at W12 and W24. Patient satisfaction, assessed at baseline and W24 with the Patient Acceptable Symptom State (PASS), was used as a surrogate marker of no flare. A correlation was sought between the FLARE-RA score at W12 and W24 and the area under the receiver operating characteristic (ROC) curve (AUC) for monthly DAS28ESR. The optimal FLARE-RA cut-off below which patient satisfaction reached the PASS was explored with an ROC curve. RESULTS: A total of 139 patients were included (mean age 57.3 ± 13.8 years, 74.1% women, mean RA duration 10.8 ± 9.2 years, mean DAS28ESR 5.8 ± 1.1). The correlation between the FLARE-RA score and DAS28ESR AUC was moderate at all times: ρ = 0.41 at W12 (P < 0.0001) and 0.51 at W24 (P < 0.0001). The optimal cut-off for the FLARE-RA score to identify absence of flare (i.e. an acceptable situation based on the PASS) was 2.3 with an AUC of 0.81. CONCLUSION: FLARE-RA and DAS28ESR assessment differ; we propose a FLARE-RA cut-off of 2.3, below which the situation (i.e. without flare) is acceptable for patients.
OBJECTIVE: The Flare Assessment in RA (FLARE-RA) self-administered questionnaire aims to identify patients who had flare in the interval between two consultations. This study aimed to establish a threshold for FLARE-RA score to identify RA flare. METHODS: The Tocilizumab SubCutAneous study evaluated the efficacy and safety of s.c. tocilizumab (TCZ) to patients with active RA. Disease activity was assessed with the DAS28ESR at baseline and at week 2 (W2), W4, W12 and W24. The FLARE-RA questionnaire was administered at W12 and W24. Patient satisfaction, assessed at baseline and W24 with the Patient Acceptable Symptom State (PASS), was used as a surrogate marker of no flare. A correlation was sought between the FLARE-RA score at W12 and W24 and the area under the receiver operating characteristic (ROC) curve (AUC) for monthly DAS28ESR. The optimal FLARE-RA cut-off below which patient satisfaction reached the PASS was explored with an ROC curve. RESULTS: A total of 139 patients were included (mean age 57.3 ± 13.8 years, 74.1% women, mean RA duration 10.8 ± 9.2 years, mean DAS28ESR 5.8 ± 1.1). The correlation between the FLARE-RA score and DAS28ESR AUC was moderate at all times: ρ = 0.41 at W12 (P < 0.0001) and 0.51 at W24 (P < 0.0001). The optimal cut-off for the FLARE-RA score to identify absence of flare (i.e. an acceptable situation based on the PASS) was 2.3 with an AUC of 0.81. CONCLUSION: FLARE-RA and DAS28ESR assessment differ; we propose a FLARE-RA cut-off of 2.3, below which the situation (i.e. without flare) is acceptable for patients.