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1、Defining Remission in Rheumatoid ArthritisPart 1: Why is a new remission definition in rheumatoid arthritis needed?Background Increasing numbers of patients reach remission Abundance of remission definitions strict definitions:American Rheumatism Association (Pinals); SDAI/CDAI loose definitions:DAS
2、/DAS28; mARA; SJC0/TJC0/ESR10; MDANeed for a uniform definition (RA trials, practice)Etymology Remittere (L): to send back; to decrease; to relax. Remission (med dictionary): an abatement or lessening of the manifestations of a disease (Wiki): the state of absence of disease activityin patients with
3、 a chronic illness, with the possibility of return of disease activityConcept: Key Points Remission is a state, not change or transition Absence of disease activityConcept: Remission Related but not identical to remission: Cure: disease does not return Arrest: disease progression is stopped Intermis
4、sion: period of no activity between two periods of active disease Remission is antithetical to the following: Relapse: return of disease activity Flare: substantial increase of disease activityCurrent Definitions: American Rheumatism Association* 5 or more must be fulfilled for at least 2 consecutiv
5、e months: Morning stiffness not exceeding 15 minutes No fatigue No joint pain (by history) No joint tenderness or pain on motion No soft tissue swelling in joints or tendon sheaths ESR (W) 30 mm/h (f); 20 mm/h (m)* Pinals RS, et al. Arthritis Rheum 1981;24:1308-15.ARA (Pinals) 3 groups of RA patient
6、s classified according to the rheumatologist: complete remission partial remission active disease Sensitivity 72%; Specificity 90% (against partial remission)Problems with ARA (Pinals) Definition Depends on measures not widely assessed now in RA trials: Morning stiffness (absent in many patients wit
7、h active RA) Tendon sheath swelling Very strict definition Attainment very rare in RA trials Thus unrealistic target for treatment success Many unvalidated modifications in useDAS/DAS 28 Threshold for Remission* DAS: Ritchie joint index and 44 swollen joint ct DAS28: 28 tender 43:1252-5.DAS/DAS28 Re
8、mission Validation against ARA (Pinals) criteria in Nijmegen data, moderately active disease Modified ARA (Pinals) criteria used: Fatigue not assessed Remission defined as 4 out of 5 remaining criteria Sensitivity and specificity against modified ARA (Pinals) 87%SDAI/CDAI Remission SDAI = (28TJC) +
9、(28SJC) + MDGA + PtGA + CRP* CDAI = (28TJC) + (28SJC) + MDGA + PtGA* SDAI remission 3.3* CDAI remission 2.8* Developed in patient profile exercise and validated in observational datasets* Smolen JS et al. Rheumatology. 2003;42:244 * * Aletaha D et al. Arthritis Rheum. 2005;52:2625Other Definitions o
10、f Remission and Related States PAS and RAPID3:* both based solely on patient reported outcomes Minimal Disease Activity:* developed at OMERACT, based on core set measures Yet other definitions exist, both for remission and minimal disease activity* Wolfe F et al. J Rheumatol 2005;32:2410-5. * Wells
11、GA et al. J Rheumatol 2005;32:2016-24.Another Reason to Define Remission: Associated with Best Functional Outcome (BeSt Data)Koevoets et al. Arthritis Rheum 2009; 60 Suppl 10:957.Mean HAQ score at year 4Mean disease activity at year 4DAS- CRP ESRDAS28-SDAI CDAICRP ESRHow Strict Are Current Definitio
12、ns? Prevalence of Remission in QUEST-RA* Survey of RA patients in 24 countriesSokka T et al. Arthritis Rheum 2008;58:2642-51.010203040ARAPhGA 0.3RAPID3 1SJC (42), TJC = 0, ESR = ARASJC (28), TJC = 0 ESR = ARACDAI 2.8DAS28 2.6Aletaha et al. Arthritis Res Ther. 2005;7:R796-806.60200-204020601020303010
13、05432Time-averaged disease activityR=0.58R=0.59R=0.54DAS28SDAICDAIChange in Larsen scoreLevels of RA Disease Activity Measures Are Associated With X-ray Progression Background: Conclusion Strict and loose definitions of RA remission ARA (Pinals), CDAI/SDAI, PAS/RAPID3 - strict Modified ARA, DAS28 -
14、loose No definition universally used Variability in how each definition is operationalized Remission leads to better RA outcomes Agreement on need for uniform definition(s)ACR/EULAR 2011 Provisional Definition of Rheumatoid Arthritis Remission:How was it developed and how will it work?Who was involv
15、ed? A broad Parent Committee, including representatives of ACR, EULAR and OMERACT, set out goals, defined the tasks, evaluated interim analyses RA trialists/clinicians + patient experts A smaller Working Committee carried out the analyses and presented findings to the Parent CommitteeOutline of Approach Charge from committee Survey committee members on threshold for remission Address whether patient reported outcomesshould be included Create possible definitions of remission Test possible definitions Predictive validity Face validity Decide on definition(s) of remission Address remai
