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Abstract Number: 379

Persistency and Predictors of Persistency of Adalimumab Among Rheumatoid Arthritis (RA) Patients in a US Registry

Allan Gibofsky1, Katherine C. Saunders2, Arijit Ganguli3, Mary Cifaldi4, Shannon Grant5, Jerry Clewell4, Neelufar Mozaffarian4, James Shaw6, Reva McCaskill4, George W. Reed7 and Jeffrey D. Greenberg8, 1Medicine and Public Health, Hospital for Special Surgery, New York, NY, 2Corrona, LLC., Southborough, MA, 3AbbVie, North Chicago, IL, 4Abbott Laboratories, Abbott Park, IL, 5Axio Research LLC, Seattle, WA, 6Global Health Economics and Outcomes Research, Abbott, Abbott Park, IL, 7University of Massachusetts Medical School, Worcester, MA, 8Rheumatology, NYU Hospital for Joint Diseases, New York, NY

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Anti-TNF therapy and rheumatoid arthritis (RA)

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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:

There are limited observational data to guide physician decision-making when choosing to begin a patient on a new biologic treatment. Understanding real-world trends in persistency on therapy and factors related to persistency would aid in this process. We sought to identify predictors of persistence on adalimumab (time to discontinuation and change in treatment) in a large US registry of RA patients.

Methods:

The CORRONA registry is a large, multicenter, longitudinal database of RA patients enrolled from > 90 academic and private practices across the USA. RA patients enrolled in CORRONA between March 2002 and September 2011 who initiated adalimumab and had at least one follow up visit post-initiation were included in this analysis. Discontinuation of adalimumab and treatment change were modeled separately. Discontinuation was defined as stoppage of adalimumab for any duration, while treatment change included discontinuation of adalimumab, change in adalimumab dose/frequency, or adding /discontinuing a DMARD. Kaplan-Meier curves were used to estimate persistence quartiles. Associations between patient characteristics and persistence were estimated using univariate and multivariate proportional hazards (PH) regression models.

Results:

1639 patients initiated adalimumab and had at least one follow-up visit, 1003/1639 patients discontinued adalimumab, with a Kaplan-Meier estimate of median days to discontinuation: 632 (95% CI: 564.5 – 717). A multivariable model showed risk of discontinuation was associated with prior use of another biologic, number of swollen joints, duration of RA and prednisone use at initiation (Table 1). 1358/1639 patients experienced some form of treatment change. Median days to treatment change: 276 (95% CI: 258 – 298). Likelihood of treatment change increased with prior use of biologics, number of swollen joints and prednisone use at initiation; it decreased with concomitant use of MTX at initiation (Table 1). Hazard Ratios represent the baseline risk association.

Conclusion:

In the CORRONA registry, persistence on adalimumab was inversely correlated with factors suggestive of high disease severity. Patients using concurrent MTX with adalimumab at initiation were less likely to experience a change in their treatment compared to non-MTX users.

 

Table 1.

 

Hazard Ratio

(95% Confidence Interval)

P-value

Predictors of Discontinuation

   Use of previous biologic

1.532*

(1.259-1.864)

<0.0001

   SJC at initiation

1.010+

(1.001-1.018)

0.0301

   RA duration at initiation

1.005

(1.002-1.007)

0.0002

   Prednisone use at initiation

1.279

(1.180-1.386)

<0.0001

Predictors of Change in Treatment

   Use of previous biologic

1.613*

(1.438-1.809)

<0.0001

   SJC at initiation

1.015

(1.007-1.023)

0.0001

   Prednisone use at initiation

1.116

(1.069-1.166)

<0.0001

   MTX use at initiation

0.876

(0.835-0.919)

<0.0001

SJC, swollen joint count

*time varying association. HR estimates initial risk association; association decreases over time

+time varying association. HR estimates initial risk association; association increases over time


Disclosure:

A. Gibofsky,

Abbott Laboratories,

1,

Amgen,

1,

Bristol-Myers Squibb,

1,

GlaxoSmithKline,

1,

Johnson & Johnson,

1,

Pfizer Inc,

1,

Abbott Laboratories,

5,

Amgen,

5,

Genentech/Roche,

5,

Pfizer Inc,

5,

Abbott Laboratories,

8,

Amgen,

8,

Genentech/Roche,

8,

Pfizer Inc,

8;

K. C. Saunders,

Corrona,

3;

A. Ganguli,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

M. Cifaldi,

Abbott Laboratories,

1,

Abbott Laboratories,

3;

S. Grant,

Axio Research LLC,

3;

J. Clewell,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

N. Mozaffarian,

Abbott Laboratories,

1,

Abbott Laboratories,

3;

J. Shaw,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

R. McCaskill,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

G. W. Reed,

Corrona,

2,

University of Massachusetts Medical School,

3,

Corrona,

5,

Harvard Medical School,

;

J. D. Greenberg,

Corrona,

4,

AstraZeneca, Novartis, Pfizer,

5.

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