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Abstract Number: 486

Impact of Adalimumab Therapy On Laboratory Parameters of Interest in Patients with Early or Long-Standing Rheumatoid Arthritis

Daniel Furst1, Ana P. Lacerda2, Nupun Andhivarothai3, Jasmina Kalabic4 and Neelufar Mozaffarian3, 1David Geffen School of Medicine, Div of Rheumatology, University of California at Los Angeles, Los Angeles, CA, 2Abbott Laboratories, São Paulo, Brazil, 3Abbott Laboratories, Abbott Park, IL, 4Abbott GmbH & Co. KG, Ludwigshafen, Germany

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Adalimumab, laboratory tests, rheumatoid arthritis (RA) and safety

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose: The systemic inflammation of rheumatoid arthritis (RA) can have detrimental effects on the hematopoietic and cardiovascular systems. Additionally, effective DMARD treatments for RA can be hemato- or hepatotoxic. The effects of adalimumab (ADA) in combination with methotrexate (MTX) therapy on these systems in patients with early or long-standing RA have not been previously summarized. This analysis evaluates the effects of ADA+MTX therapy compared to MTX monotherapy on laboratory and vital sign parameters relevant to hematopoietic, cardiovascular, and hepatic organ systems.

Methods: Clinical trials DE013 and OPTIMA (MTX-naïve patients, early RA, mean duration=0.8 yrs in DE013, 0.35 yrs in OPTIMA) and DE019 (MTX-incomplete responders, long-standing RA, mean duration=11 yrs) were double-blind studies that compared ADA+MTX therapy to MTX monotherapy for ≥6 months. This post hocanalysis determined the percentage of patients who developed neutropenia, lymphocytopenia, thrombocytopenia, anemia, reduction in Hgb from baseline, increases in creatinine, increases in AST or ALT, and prevalence of stage 2 hypertension at any time during the first 6 months of ADA treatment. Mean laboratory values and vital signs (all studies) and fasting lipids (OPTIMA only) were determined at baseline and 6 months and compared using a contrast within a one-way analysis of variance.

Results: Incidence rates for laboratory abnormalities are listed in the table. After 6 months, mean increase in Hgb levels was higher in ADA+MTX arms than in the MTX-only arms in early RA and in long-standing RA. Mean HDL cholesterol changes were not different in the ADA+MTX treatment group compared to MTX alone. Mean total and LDL cholesterol increased numerically with ADA+MTX therapy vs. MTX alone. No differences were observed in the incidences or mean changes in serum creatinine, ALT, or AST between ADA+MTX therapy and MTX alone.

Conclusion: Over an observation period of 6 months, RA patients treated with ADA+MTX exhibited laboratory abnormalities and hypertension at levels and frequencies similar to those seen in patients treated with MTX alone. In fact, ADA+MTX therapy was associated with a statistically significantly reduced incidence of anemia and lymphocytopenia. Similar results were observed whether evaluating ADA treatment in MTX-naïve patients or in those with long-standing RA.

 

Table. Incidence and mean change from baseline in laboratory values of interest at 6 months of treatment

 

Early RA

Long-standing RA

PBO+MTX

N = 774

ADA+MTX

N = 783

PBO+MTX

N = 200

ADA+MTX

N = 207

Incidence, n (%)

Neutropenia

<1500 to 500/mm3

14 (1.8)

25 (3.2)

0

1 (0.5)

<500/mm3

1 (0.1)

1 (0.1)

0

0

Lymphocytopeniaa

<800 to 500/mm3

56 (7.2)

25 (3.2)*

37 (18.5)

17 (8.2)*

<500 to 200/mm3

15 (1.9)

3 (0.4)*

4 (2.0)

2 (1.0)

Thrombocytopeniaa

50,000 to <75,000/mm3

0

1 (0.1)

0

0

Anemia

Hgb <10.0–8.0 g/dL

55 (7.1)

28 (3.6)*

11 (5.5)

3 (1.4)*

Hgb <8.0–6.5 g/dL

4 (0.5)

2 (0.3)

0

0

Hemoglobin decreased

Hgb decrease -3.0 to -1.0 g/dL

263 (34.0)

176 (22.5)*

71 (35.5)

45 (21.7)*

Hgb decrease >-3.0 g/dL

3 (0.4)

0

1 (0.5)

2 (1.0)

Serum creatinine increased

>1.5 to 3X ULN

5 (0.6)

1 (0.1)

0

0

>3 to 6X ULN

0

1 (0.1)

0

0

>6X ULN

0

0

1 (0.5)

1 (0.5)

AST increased

AST >3–5X ULN

8 (1.0)

10 (1.3)

1 (0.5)

1 (0.5)

AST >5X ULN

2 (0.3)

1(0.1)

2 (1.0)

0

ALT increased

ALT >3–5X ULN

17 (2.2)

23 2.9)

1 (0.5)

2 (1.0)

ALT >5X ULN

3(0.4)

5 (0.6)

2 (1.0)

0

Stage 2 hypertensionb

79 (10.2)

82 (10.5)

52 (26.0)

64 (30.9)

Mean change from baseline

Hemoglobin, g/dL

0.24

0.45*

0.18

0.44*

Fasting lipidsc

HDL cholesterol, mmol/L

0.078

0.119

–

–

LDL cholesterol, mmol/L

0.193

0.284*

–

–

Cholesterol, mmol/L

0.280

0.438*

–

–

*P <.05 for ADA+MTX vs. PBO+MTX; χ 2 test for incidence rates. an=0 for low values/categories not shown; bsystolic BP≥160 mm Hg or diastolic BP≥100 mm Hg; cOPTIMA study only. /mm3, cells per cubic millimeter; ADA, adalimumab; AST, aspartate transaminase; ALT, alanine transaminase; g/dL, gram per deciliter; HDL, high-density lipoprotein; Hgb, hemoglobin; LDL, low-density lipoprotein; MTX, methotrexate; PBO, placebo; RA, rheumatoid arthritis; ULN, upper limit of normal.


Disclosure:

D. Furst,

Abbott, Actelion, Amgen, BiogenIdec, BMS, Centocor, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, and UCB,

2,

Abbott, Actelion, Amgen, BiogenIdec, BMS, Centocor, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, and UCB,

5,

Abbott, Actelion, Amgen, BiogenIdec, BMS, Centocor, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, and UCB,

8;

A. P. Lacerda,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

N. Andhivarothai,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

J. Kalabic,

Abbott Laboratories,

3,

Abbott Laboratories,

1;

N. Mozaffarian,

Abbott Laboratories,

1,

Abbott Laboratories,

3.

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