Agnès Portier1, Laure Gossec2, Florence Tubach3, Toni Alfaiate3, Thao Pham4, Alain Saraux5, Martin Soubrier5, Thierry Schaeverbeke6, Jean-Francis Maillefert7, Xavier Mariette8, David Hajage3, Bruno Fautrel2. 1. Sorbonne Universités, UPMC Université Paris 06, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), 75013 Paris, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 75013 Paris, France; Rheumatology Department, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. Electronic address: aportier@hpsj.fr. 2. Sorbonne Universités, UPMC Université Paris 06, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), 75013 Paris, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 75013 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. 3. Département d'Épidémiologie et Recherche clinique, Hôpital Bichat, AP-HP, 75018 Paris, France; Inserm, CIC-EC 1425, UMR 1123, ECEVE, 75018 Paris, France; Université Paris Diderot, Sorbonne Paris Cité, UMR 1123, 75018 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. 4. Aix-Marseille University, AP-HM, Rheumatology Department, Sainte-Marguerite Hospital, 13006 Marseille, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. 5. Rheumatology Department, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. 6. Victor-Segalen-Bordeaux 2 University, Rheumatology Department, Pellegrin University Hospital, 33000 Bordeaux, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. 7. Burgundy University, Rheumatology Department, Dijon University Hospital, 21000 Dijon, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. 8. Paris Sud University-Paris 11, AP-HP, Rheumatology Department, Bicêtre Hospital, 94700 Le Kremlin-Bicêtre, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
Abstract
OBJECTIVES: Patient's and physician's perspective can differ in rheumatoid arthritis (RA). The aim was to define the concept of patient-reported flares. METHODS: Post-hoc analysis of a randomized controlled trial of a step-down strategy in RA patients treated with anti-TNF, in DAS28-remission for ≥6 months, randomized to either "spacing" or "maintaining" anti-TNF. The occurrence of patient-reported flares (PRF) was evaluated every 3 months for 18 months by: "Over the last 3 months, did you experience symptoms suggestive of disease exacerbation?". Visits with and without PRF were compared, using a linear mixed effects model, in terms of symptoms, disability based on the Health Assessment Questionnaire, quality of life based on Short Form 36 Health Survey and DAS28-based relapses (DBR), defined as an increase of DAS28>0.6 and an absolute value of DAS28>2.6. The agreement between PRF and DBR was measured by the kappa coefficient on repeated data. RESULTS: In all, 137 patients were analyzed: mean age 55±11 years, females 78%, mean RA duration 9.5±8.0 years. Over the 18 months, PRF concerned 27.2% of the 940 available visits. DBR and PRF were observed in 24% and 16% of 940 visits for 137 patients respectively. All the items were associated with PRF with standardized effect size between -0.58 (SF36 PCS) and 0.87 (DAS28). The agreement between PRF and DBR was moderate (κ=0.44). CONCLUSION: The concept of flare refers to more than just RA disease activity.
RCT Entities:
OBJECTIVES:Patient's and physician's perspective can differ in rheumatoid arthritis (RA). The aim was to define the concept of patient-reported flares. METHODS: Post-hoc analysis of a randomized controlled trial of a step-down strategy in RApatients treated with anti-TNF, in DAS28-remission for ≥6 months, randomized to either "spacing" or "maintaining" anti-TNF. The occurrence of patient-reported flares (PRF) was evaluated every 3 months for 18 months by: "Over the last 3 months, did you experience symptoms suggestive of disease exacerbation?". Visits with and without PRF were compared, using a linear mixed effects model, in terms of symptoms, disability based on the Health Assessment Questionnaire, quality of life based on Short Form 36 Health Survey and DAS28-based relapses (DBR), defined as an increase of DAS28>0.6 and an absolute value of DAS28>2.6. The agreement between PRF and DBR was measured by the kappa coefficient on repeated data. RESULTS: In all, 137 patients were analyzed: mean age 55±11 years, females 78%, mean RA duration 9.5±8.0 years. Over the 18 months, PRF concerned 27.2% of the 940 available visits. DBR and PRF were observed in 24% and 16% of 940 visits for 137 patients respectively. All the items were associated with PRF with standardized effect size between -0.58 (SF36 PCS) and 0.87 (DAS28). The agreement between PRF and DBR was moderate (κ=0.44). CONCLUSION: The concept of flare refers to more than just RA disease activity.
Authors: Elena Myasoedova; Cynthia S Crowson; Rachel E Giblon; Kathleen McCarthy-Fruin; Daniel E Schaffer; Kerry Wright; Eric L Matteson; John M Davis Journal: Clin Rheumatol Date: 2019-07-01 Impact factor: 2.980