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Abstract Number: 569

Clinical and Sociodemographic Characteristics of Patients with Rheumatoid Arthritis (RA) Starting Triple Therapy and a Combination of a TNF Inhibitor and Methotrexate from a Large US Registry

Joel Kremer1,2, J. Lynn Palmer3, George W. Reed4, Dimitrios A. Pappas5, Leslie R Harrold6, Jeffrey Greenberg1 and Jeffrey R. Curtis7, 1Corrona LLC, Waltham, MA, 2Albany Medical College and The Center for Rheumatology, Albany, NY, 3Corrona Research Foundation, Albany, NY, 4UMass Medical School, Worcester, MA, 5Columbia University, New York, NY, 6University of Massachusetts Medical School, Worcester, MA, 7University of Alabama at Birmingham, Birmingham, AL

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: rheumatoid arthritis (RA) and therapy

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Session Information

Date: Sunday, October 21, 2018

Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology

Session Type: ACR Poster Session A

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

Background/Purpose: The combination of methotrexate (MTX), hydroxychloroquine (HCQ) and sulfasalazine (SSZ) has been called Triple Therapy (Triple) and has been compared with a combination of TNF inhibitors and MTX (TNFi + MTX). We sought to examine the use of Triple in a large US registry and compare the clinical and sociodemographic characteristics of the patients starting either therapy to determine if there were clinically relevant differences at initiation.

Methods: All eligible initiations in the Corrona registry from 2001-2017 were considered. Initiation of Triple was defined as initiation of one or more of the three drugs resulting in the first time use of all three drugs. Initiation of TNFi+MTX was defined as the initiation of TNFi resulting in the first time use of TNFi + MTX. Initiations were in patients who were biologic/small molecule naïve. Sociodemographic, clinical and disease characteristics were compared at time of initiation between the therapies. Patients initiating Triple who later initiated TNFi+MTX were not included in the TNFi+MTX cohort. Standardized mean differences (SMDs) were used to compare patients initiating Triple vs TNFi+MTX therapy; |SMDs| >0.15 were considered clinically relevant.

Results: From 2001- 2017, we identified 3452 TNFi+MTX and 226 Triple eligible initiations. Table 1 describes patient characteristics with |SMDs|>0.15. Triple initiators were older, had longer disease duration, were more likely to have Medicare coverage, and more likely to be RF+ or CCP+. Triple initiators had a history of more comorbidities than TNFi+MTX initiators. TNFi +MTX initiators had higher disease activity measures than Triple initiators: CDAI and all its components, patient fatigue and mHAQ. There were larger differences in MD Global and joint counts (|SMDs|>0.30) than Pt Global and Pt Fatigue (|SMDs| < 0.19) At start of therapy patient pain and prednisone, analgesic and NSAID use were not different (|SMDs| <0.15).

Conclusion: Utilization of Triple was not common over a period of 16 years covered by the registry. Pts started on triple were older, had less severe RA and a higher comorbidity burden. These differences are likely to impact response to treatment as it appears that rheumatologists channeled pts with more severe RA to TNFi + MTX, while pts with a h/o comorbidities were more likely to receive Triple.

Table 1. Clinically relevant standardized differences (SMDs) between groups, all initiators

Triple

TNFi + MTX

Variable

N

Proportion

or Mean

N

Proportion

or Mean

SMD

P value

Age

225

59.94

3429

56.66

0.250

0.0003

Medicare Insurance

215

0.34

3248

0.27

0.178

0.01

Duration RA

224

8.64

3414

6.36

0.267

0.0001

RF+ or CCP+

160

0.82

2234

0.75

0.160

0.05

Hx Malignancy

226

0.15

3452

0.04

0.475

<0.0001

Hx Serious Infections

226

0.06

3452

0.03

0.209

0.002

Charlson Index

226

1.32

3452

1.21

0.230

0.008

CDAI

218

14.9

3332

20.66

-0.404

<0.0001

28 Tender Joint Count

218

4.14

3332

6.70

-0.370

<0.0001

28 Swollen Joint Count

218

4.50

3332

6.45

-0.314

<0.0001

Patient Global (0-100)

218

36.48

3332

40.60

-0.152

0.03

MD Global (0-100)

218

26.12

3332

34.53

-0.370

<0.0001

mHAQ (0-3)

224

0.39

3363

0.48

-0.185

0.007

Pt Fatigue (0-100)

119

36.53

1770

42.18

-0.187

0.05


Disclosure: J. Kremer, Corrona LLC, 1, 3; J. L. Palmer, Corrona LLC, 1, 3; G. W. Reed, Corrona, 1, 3; D. A. Pappas, Corrona, LLC, 3,Novartis, 9; L. R. Harrold, Corrona, LLC, 1,Pfizer, Inc., 2,Roche, Bristol-Myers Squibb, 5,Corrona, LLC, University of Massachusetts Medical School, 3; J. Greenberg, Corrona LLC, 1,Corrona LLC, 3,Eli Lilly, Genentech, Janssen, Pfizer Inc, 5; J. R. Curtis, AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Radius, Roche/Genentech, UCB, 2,AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Radius, Roche/Genentech, UCB, 5.

To cite this abstract in AMA style:

Kremer J, Palmer JL, Reed GW, Pappas DA, Harrold LR, Greenberg J, Curtis JR. Clinical and Sociodemographic Characteristics of Patients with Rheumatoid Arthritis (RA) Starting Triple Therapy and a Combination of a TNF Inhibitor and Methotrexate from a Large US Registry [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/clinical-and-sociodemographic-characteristics-of-patients-with-rheumatoid-arthritis-ra-starting-triple-therapy-and-a-combination-of-a-tnf-inhibitor-and-methotrexate-from-a-large-us-registry/. Accessed .
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