ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2655

Clinically Important Worsening (CIW) of RA Disease Activity Requiring an Increase in Therapy Can be Identified Using a Combined Patient and Physician Report of Flare

VP Bykerk1,2, Clifton O. Bingham III3, Ernest H. Choy4, Daming Lin2, Rieke Alten5, Robin Christensen6, Daniel E. Furst7, Francis Guillemin8, Sarah Hewlett9, Amye L. Leong10, Lyn March11, Thasia Woodworth12, Gilles Boire13, Carol Hitchon14, Shahin Jamal15, Edward C. Keystone16, Janet E. Pope17, J Carter Thorne18, Diane Tin19, Susan J. Bartlett20,21,22 and CATCH Investigators and OMERACT Flare Group, 1Rheumatology, Hospital for Special Surgery, New York, NY, 2Rheumatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, 3Rheumatology, Johns Hopkins University, Baltimore, MD, 4Cardiff University, Institute of Infection and Immunity, Tenovus Building, University Hospital of Wales, Cardiff, United Kingdom, 5Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, 6The Parker instutute, RC, Copenhagen, Denmark, 7Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 8University of Lorraine, Nancy, France, 9Academic Rheumatology, University of West of England, Bristol, United Kingdom, 10Spokesperson; Strategic Relations, BONE AND JOINT DECADE, Santa Barbara, CA, 11Department of Rheumatology, Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute, University of Sydney & Department of Rheumatology, Royal North Shore Hospital, St Leonards, Sydney, Australia, 12Medicine, Division of Rheumatology, David Geffen School of Medicine, Los Angeles, CA, 13Department of Medicine/Division of Rheumatology, Université de Sherbrooke, Sherbrooke, QC, Canada, 14Department of Rheumatology, University of Manitoba, Winnipeg, MB, Canada, 15Vancouver Coastal Health, Vancouver, BC, Canada, 16Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, 17Monsignor Roney Bldg/Rheum, University of Western Ontario, St Joseph Health Care, London, ON, Canada, 18University of Toronto, Toronto, ON, Canada, 19The Arthritis Program, Southlake Regional Health Centre, Newmarket, ON, Canada, 20Medicine , Divisions of Clinical Epidemiology, Rheumatology, Respirology, McGill University, Montreal, QC, Canada, 21Division of Rheumatology, Johns Hopkins University, Baltimore, MD, 22Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , ,

Session Information

Date: Tuesday, November 10, 2015

Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: A reference point
for clinically important worsening (CIW) of RA disease activity requiring
retreatment or escalation is needed for randomized trials of treatment
withdrawal. These studies are usually performed in patients (pt) in states of low
disease activity (LDA) or remission (REM). Restarting RA therapy needs a Pt-MD concordant
assessment of worsening (“flare”) to maximize adherence. Here we examine the
construct and convergent validity of a combined Pt-MD concordant report of
flare that indicates CIW in pts who are in LDA/REM. 

Methods: CATCH (Canadian early ArThritis CoHort)
Pts were eligible for study if they were in DAS28 REM or LDA at first (V1) of 2
sequential visits (3 or 6 months apart).  RA flare was assessed at the 2nd
visit (V2). Pts reported if their RA was flaring (yes/no) and if yes the
severity and duration. Concurrently, MDs classify them as flaring (yes/no). Changes
in disease activity and treatment, OMERACT core flare domains, MD measures,
inflammatory markers, and DAS28 were assessed in pts reporting flare, MDs classifying
flare, and when Pt-MDs were concordant in identifying flare.

Results: Of 849 RA pts who completed
OMERACT flare questions twice between 11/2011-10/2014, 360 (42%) were in LDA or
REM at the 1st of paired visits. Pts most often reported a flare
duration lasted >14 days in Pt-MD concordant flares with mean (SD) severity
rating of 5.0 (2.3)(Table 1). DAS28 worsening was less in MD-report of flare
DAS28 0.9 (1.3) vs 1.8 (1.2) in Pt-MD concordant flare. Prior treatment
reduction/withdrawal was observed in 36% of Pt-MD flares with subsequent treatment
addition in 61% at/after the 2nd “Flare”.  Mean differences in
measures of RA disease activity, (PROs, clinical, and laboratory assessments),
were significant in pt-reported flare, and of greater magnitude with concordant
Pt-MD flare. This was notable for all measures in the existing RA core set for
monitoring disease activity and the expanded OMERACT Flare Core Set (Table 2). 
 

 

Conclusion:  A concordant Pt-MD report of
flare can provide a feasible assessment of CIW of RA disease activity
associated with worsening in ACR RA core set measures and domains in the expanded
OMERACT Flare core set. This anchor for CIW is often associated with stopping
or reducing treatment and with subsequent increases in therapy.  These data
provide a rationale for using this Pt-MD anchoring construct to identify CIW
for existing and new RA disease activity measures.  

 

Table 1: Patient and MD Reported Flare Characteristics, DAS28 worsening, and changes in treatment.

Patients Previously in DAS28 LDAS or REM (N=360)

Patient Flare (Yes)

MD Flare

Patient Flare Yes/ MD Flare

 

N=58 (16%)

N=71 (20%)

N=28 (8%)

Flare severity (0-10) (mean SD)

4.4 (2.1)

4.5 (2.6)

5.0 (2.3)

Duration of flare

   1-3 days

   4-7 days


   8-14 days


   >14 days

 

12 (21%)

6 (10%)

12 (21%)

28 (48%)

 

5 (18%)

4 (14%)

6 (21%)

13 (46%)

 

5 (18%)

4 (14%)

6 (21%)

13 (46%)

Change in DAS28:

  DAS28 at time of flare

3.2 (1.4)

3.0 (1.4)

3.9 (1.4)

  DAS28 at previous visit

2.1 (0.7)

2.1 (0.6)

2.1 (0.7)

  Worsening of DAS28

1.1 (1.4)

0.9 (1.3)

1.8 (1.2)

Treatment Reduced/Stopped Before Flare Assessment

  Recent Treatment Reduction (from visit 1)

22 (38%)

29 (41%)

9 (32%)

  Recent Treatment Cessation (from visit 1)

19 (33%)

28 (39%)

7 (25%)

  Recent Treatment Reduction or Cessation (from visit 1)

24 (41%)

34 (48%)

10 (36%)

Treatment Increase with Flare

MD Intent to increase Treatment Increase (at 2nd Visit)

25 (45%)

37 (53%)

17 (61%)

Observed Treatment Increase (Visit 2 or next visit):

Non MTX DMARDS

MTX added/increased (dose or po to sc)

Biologics added/switched (not due to side effect)

Steroids (po/IM or IA; not used in prior visit)

NSAIDs added (not used in the prior visit)

 

9 (16%)

2 (6%)

2 (3%)

7 (12%)

3 (5%)

 

10 (14%)

3 (7%)

3 (4%)

7 (10%)

3 (4%))

 

7 (25%)

1 (7%)

2 (7%)

4 (14%)

2 (7%)

 

Table 2: Changes in ACR Core Set and OMERACT Flare Core Set Domains with Patient-MD Report of Flare.

Patients Previously in DAS28 LDAS or REM

Patient Flare (yes) *

Mean Difference

of Change

(95% CI)

Pt Yes Flare

/ MD Yes Flare

Pt No Flare

/ MD No Flare

Mean Difference

 of Change

(95% CI)

Domains

Yes

No

N = 58

N = 302

N = 28

N = 219

OMERACT Flare Questionnaire Items (0-10)

Pain

1.7 (2.4)

-0.4 (1.8)

2.0 (1.4, 2.7)

2.3 (2.6)

-0.5 (1.7)

2.7 (1.7, 3.8)

Stiffness

1.3 (3.0)

-0.3 (1.7)

1.6 (0.8, 2.4)

2.1 (3.1)

-0.4 (1.7)

2.5 (1.3, 3.7)

Function

1.6 (2.7)

-0.3 (1.9)

1.9 (1.2, 2.6)

1.8 (2.7)

-0.4 (1.8)

2.2 (1.1, 3.2)

Fatigue

0.6 (3.1)

-0.3 (2.1)

0.9 (0.1, 1.8)

1.6 (3.0)

-0.5 (1.9)

2.1 (0.9, 3.3)

Participation

1.5 (2.7)

-0.3 (1.8)

1.8 (1.1, 2.5)

1.8 (2.7)

-0.4 (1.6)

2.2 (1.1, 3.3)

Pt Global

1.9 (3.0)

-0.3 (2.1)

2.2 (1.3, 3.0)

2.6 (2.8)

-0.3 (2.2)

3.0 (2.1, 3.9)

Physician Measures

MD Global (0-10)

1.2 (2.3)

-0.1 (1.3)

1.3 (0.7, 2.0)

2.7 (2.1)

-0.3 (1.2)

3.0 (2.1, 3.8)

MD TJC28

2.8 (4.5)

0.3 (2.4)

2.4 (1.2, 3.7)

4.8 (5.5)

0.2 (1.9)

4.6 (2.4, 6.7)

MD SJC28

1.6 (4.0)

0.0 (1.4)

1.6 (0.5, 2.7)

3.4 (5.0)

-0.1 (1.2)

3.6 (1.6, 5.5)

Acute Phase Reactants

CRP (mg/L)

3.0 (11.0)

0.1 (5.9)

2.9 (-0.2, 6.1)

5.8 (15.0)

-0.1 (5.6)

5.9 (-0.4, 12.1)

ESR  (mm/Hr)

4.3 (11.6)

0.6 (8.7)

3.7 (0.4, 7.0)

6.3 (14.1)

0.4 (8.5)

5.9 (0.2, 11.5)

 

Disclosure: V. Bykerk, None; C. O. Bingham III, None; E. H. Choy, Abbott, Allergan, Amgen, AZ, BMS, BI, Chelsea, Chugai, DaiichiSankyo, EliLilly, Ferring, GSK, Hospita, ISIS, Jazz, Janssen, MedImmune, Merrimack, MSD, Napp, Novimmune, Novartis, PierreFabre, Pfizer, Regeneron, Roche, Sanofi-Aventis, ScheringPlough, UCB, T, 5; D. Lin, None; R. Alten, Horizon Pharma USA, Inc, 5,Horizon Pharma USA, Inc, 2; R. Christensen, None; D. E. Furst, Gilead, 2,GlaxoSmithKline, 2,NIH, 2,Novartis Pharmaceutical Corporation, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,Genentech and Biogen IDEC Inc., 2,UCB, 2,Abbvie, 5,Actelion Pharmaceuticals US, 5,Amgen, 5,Bristol-Myers Squibb, 5,Cytori, 5,Janssen Pharmaceutica Product, L.P., 5,Gilead, 5,GlaxoSmithKline, 5,NIH, 5,Novartis Pharmaceutical Corporation, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Genentech and Biogen IDEC Inc., 5,UCB, 5,Abbvie, 8,Actelion Pharmaceuticals US, 8,Bristol-Myers Squibb, 2,Amgen, 2,Actelion Pharmaceuticals US, 2,Abbvie, 2,UCB, 8; F. Guillemin, None; S. Hewlett, None; A. L. Leong, None; L. March, None; T. Woodworth, None; G. Boire, None; C. Hitchon, Health Sciences Centre Foundation, 2; S. Jamal, None; E. C. Keystone, Janssen Inc., 2,Abbott/AbbVie, 5,Amgen, 2,Bristol-Myers Squibb, 5,Janssen Inc., 5,Hoffmann-La Roche, Inc., 5,Janssen Inc., 2,Janssen Inc., 5,Merck Pharmaceuticals, 5,Merck Pharmaceuticals, 5,Pfizer Pharmaceuticals, 5,Pfizer Pharmaceuticals, 5; J. E. Pope, None; J. C. Thorne, Amgen, Canada, 5; D. Tin, None; S. J. Bartlett, PCORI, 2,NIH, 9.

To cite this abstract in AMA style:

Bykerk V, Bingham CO III, Choy EH, Lin D, Alten R, Christensen R, Furst DE, Guillemin F, Hewlett S, Leong AL, March L, Woodworth T, Boire G, Hitchon C, Jamal S, Keystone EC, Pope JE, Thorne JC, Tin D, Bartlett SJ. Clinically Important Worsening (CIW) of RA Disease Activity Requiring an Increase in Therapy Can be Identified Using a Combined Patient and Physician Report of Flare [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/clinically-important-worsening-ciw-of-ra-disease-activity-requiring-an-increase-in-therapy-can-be-identified-using-a-combined-patient-and-physician-report-of-flare/. Accessed .

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