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Abstract Number: 380

DMARD and Biologic Use During Pregnancy Among Rheumatoid and Psoriatic Arthritis Patients in the Corrona Registry

John J. Cush1, George Reed2, Katherine C. Saunders3, Joel M. Kremer4, Jeffrey D. Greenberg5 and Arthur Kavanaugh6, 1Baylor Research Institute, Dallas, TX, 2Division of Behavioral and Preventive Medicine, University of Massachusetts Medical School, Worcester, MA, 3Corrona, LLC., Southborough, MA, 4Center for Rheumatology, Albany Medical College, Albany, NY, 5Rheumatology, NYU Hospital for Joint Diseases, New York, NY, 6UCSD School of Medicine, La Jolla, CA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: pregnancy, rheumatoid arthritis (RA) and tumor necrosis factor (TNF)

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects I: Drug Studies/Drug Safety/Drug Utilization/Disease Activity & Remission

Session Type: Abstract Submissions (ACR)

Background/Purpose: CORRONA is a nationwide longitudinal disease-based registry that includes 32875 rheumatoid (RA) and 5462 psoriatic arthritis (PsA) patients. We sought to ascertain the frequency of pregnancy among 5377 women of childbearing age within the CORRONA registry and assess the impact of pregnancy on disease activity and medication use.

Methods: Females aged 18-45 yrs, diagnosed as RA or PsA with >12 mos follow-up were included.  A preconception (PRE) visit < 12 mos of a self-reported pregnancy (PREG) was required. Disease activity and therapy were assessed at PRE and  PREG visits and included CDAI, GAS, mHAQ, TJC, SJC and the % off all DMARDs or biologics (DMARD-free).  We tallied those who flared or improved (defined: 20% change in TJC+SJC) and the percent moving to or from low activity (CDAI remission or LDAS) and high activity (CDAI moderate or severe).  Therapies were classified as MTX, non-biologic DMARDs (NB-DMARD), TNF inhibitors (TNFi), other biologics (oBiologic) or all DMARDs (NB-DMARD or TNFi or oBiologic). The outcome of pregnancy was not the object of these analyses. While 251 total pregnancies (221 pts) were identified, 147 pregnancies (126 pts) met inclusion criteria.  No differences were observed between included and excluded patients.

Results: 147 pregnancies (130 RA, 17 PsA) were found for a frequency of 2.3%. Mean age was 32.4 yrs and disease duration 7.3 yrs. Time span from PRE to PREG was 4.9 mos (RA) and 6.3 mos (PsA).  Overall drug use and disease activity was less than that seen in nonpregnant CORRONA patients (data not shown).  At the PRE visit TNFi were most often used (54%) with surprisingly less MTX (16%), oBiologic (4%), Pred (23%), NSAIDs (34%) use (Table). At PRE 69% were in CDAI remission or LDAS.  PREG impact was modest with median change from PRE-PREG being zero for 8/10 activity measures. Joint counts improved in 31% and flared in 27% during PREG, with 36% having a 1-2 increase in joint count.  From the PRE to PREG, only 13% of 101 low activity pts worsened to high activity. Conversely, 43% of those with high activity improved to low activity during PREG. MTX and NB-DMARD decreased with PREG, yet some continued MTX (4%) or NB-DMARD (21%) at PREG. Biologic use was halved from 59% (PRE) to 29% (PREG) and DMARD-free rose from 28% to 61% during PREG.  61 patients were biologic free at PRE and only 2 (3.3%) started biologics during PREG.  Conversely of 80 PRE patients who took TNFi, 42 (53%) stopped TNFi during PREG.

Conclusion: TNFi were most frequently used in those apparently planning to become pregnant and also during PREG.  RA and PsA patients who become pregnant are likely to have low level disease activity and less commonly MTX, NB-DMARD, Pred or NSAIDs. While the literature suggests up to 80% of RA patients improve during PREG, this large CORRONA cohort showed less disease activity change with 12% moving from low to high activity and only 43% moving from high to low activity during PREG.

Comparison of Therapies and Activity Pre- and during Pregnancy

(n=147)

PRE

PREG

TJC

2.0

2.2

SJC

2.0

1.9

CDAI

7.8

7.7

GAS

5.9

6.0

Low Activity %

68.9

59.9

High Activity %

31.3

17.8

mHAQ

0.22

0.22

ESR mm/hr

20.5

22.4

MTX %

15.7

4.1

NB DMARD%

40.1

21.1

TNFi %

54.4

27.2

Other Biologics

4.1

2.0

DMARD Free %

27.9

61.2

Prednisone %

23.1

12.2

NSAID %

34.0

12.2


Disclosure:

J. J. Cush,

Genentch, Pfzer, UCB, Celgene, Amgen, Novartis, CORRONA, NIH,

2,

Jensen, Savient,Pfizer, BMS,Amgen, Genetech Abbott, UCB,

5;

G. Reed,

Corrona,

5,

Corrona,

2;

K. C. Saunders,

Corrona,

3;

J. M. Kremer,

Corrona,

1,

Bristol-Myers Squibb, Genentech, Pfizer, HGS, UCB,

2,

Corrona,

4,

Abbott, Amgen, Genentech, Pfizer,

5,

Abbott, Amgen, BMS,

8;

J. D. Greenberg,

Corrona,

4,

AstraZeneca, Novartis, Pfizer,

5;

A. Kavanaugh,

Amgen, Abbott, BMS, Celgene, Roche, UCB, Janssen, Pfizer,

2.

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