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Abstract Number: 503

Safety Update On Certolizumab Pegol in Patients with Active Rheumatoid Arthritis with Long Term Exposure

Xavier Mariette1, RF. van Vollenhoven2, Vivian P. Bykerk3, Marc de Longueville4, Catherine Arendt4, Kristel Luijtens5 and John J. Cush6, 1Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France, 2Clinical Trials Unit Department of rheumatology, The Karolinska Institute, Stockholm, Sweden, 3Rheumatology, Hospital for Special Surgery, New York, NY, 4Global Medical Affairs, UCB Pharma, Brussels, Belgium, 5UCB Pharma, Brussels, Belgium, 6Baylor Research Institute, Dallas, TX

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Anti-TNF therapy and certolizumab pegol

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Session Information

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

Session Type: Abstract Submissions (ACR)

Background/Purpose: The safety of certolizumab pegol (CZP) in rheumatoid arthritis (RA) has been reported in previous pooled analyses of clinical trials. An update of long-term safety data of CZP in RA with a cut-off date of 30 Nov 2011 is provided.

Methods: The pooled analysis included 10 completed randomized controlled trials (RCTs) of CZP in RA and their open-label extensions (OLEs). Pooling was done across all doses. Some patients (pts) received CZP 400 mg Q2W (twice the registered dose) as per protocol. Adverse events were defined as those occurring after first dose and within a maximum of 84 days of last dose. Serious adverse events (SAEs) were defined conservatively by the regulatory definition1 with the addition of opportunistic infections (OIs), malignancies and medical events important to the investigator. Serious infectious events (SIEs) were defined according to the regulatory definition with addition of the need for IV antibiotics. Search terms for OIs were defined by 6 external experts and validated by the steering committee (JC, VB, RVV and XM). All cases of death, SIEs (including OIs) and malignancies were manually reviewed by external experts, classified according to pre-defined standard procedures and validated by the study authors. Deaths were categorized as primarily associated with cardiovascular (CV), infectious, malignant or other causes; malignancies were classified as non-melanoma skin cancer (NMSC), solid tumors or lymphoma. Incidence rates (IR) and event rates (ER) per 100 pt-years (PY) are presented.

Results: By 30 Nov 2011, 4049 RA pts had received CZP in all studies (RCTs and OLEs) for a total of 9277 PY. Mean exposure to CZP in all studies was 2.1 yrs (Y) (min 0.04, max 7.6); median exposure was 0.7 Y. SIEs were the most common SAEs. In total, 43 tuberculosis (TB) infections occurred in 43 pts, of which 39 occurred in Central and Eastern Europe (CEE). 58 deaths occurred in CZP pts (IR: 0.63/100 PY) as a result of 19 CV events, 13 infections, 13 malignancies and 18 other causes. 65 CZP pts in all studies developed malignancies (ER: 0.72/100 PY), with 60 pts developing solid tumors (ER: 0.67/100 PY) and 5 developing lymphoma (0.05/100 PY).

Conclusion: No new safety signals associated with CZP have emerged in this updated long-term safety analysis. While SIE rates were higher for CZP than for PBO in the RCTs, they did not increase with continued exposure to CZP. Due to the shorter duration of PBO treatment compared with CZP, comparisons between the CZP and PBO groups should be interpreted cautiously. TB incidence may be explained by high recruitment in CEE prior to 2007. The rates of malignancies and serious infections are in line with CZP data reported in the product label and anti-TNF registry data.2,3

References

1. http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm

2. Dixon et al. Arth Care Res. 2010;62:755.

3. Galloway et al. Rheumatol. 2011;50:124.

RCTs

All studies
(RCTs and OLEs)

PBO
N=1137

All CZP doses
N=2965

All CZP doses
N=4049

Total exposure (PY)

373

1302

9277

Mean exposure (days)

110

152

782

Median exposure (days)

111

112

267

IR/  100 PY

ER/ 100 PY

N pts

% pts

IR/ 100 PY

ER/ 100 PY

N pts

% pts

IR/ 100 PY

ER/ 100 PY

N pts

% pts

AEs

362.27

589.10

713

62.7

335.86

568.30

2048

69.1

188.83

328.93

3561

87.9

Leading to death

0.27

–

1

0.1

0.84

–

11

0.4

0.63

–

58

1.4

SAEs

17.01

21.73

61

5.4

20.97

29.49

260

8.8

13.96

21.31

1063

26.3

SIEs

1.35

1.34

5

0.4

5.61

6.07

72

2.4

3.64

4.32

323

8.0

All malignancies excluding NMSC

0.81

1.34

3

0.3

0.69

0.77

9

0.3

0.70

0.72

65

1.5

OIs*

0

0

0

0

1.0

1.08

13

0.4

0.67

0.69

62

1.5

*Treatment-emergent adverse events of oesophageal candidiasis were included as OIs

 

 ADDIN EN.REFLIST


Disclosure:

X. Mariette,

UCB Pharma,

5;

R. van Vollenhoven,

UCB Pharma,

5;

V. P. Bykerk,

UCB Pharma,

5;

M. de Longueville,

UCB,

3;

C. Arendt,

UCB Pharma,

3;

K. Luijtens,

UCB Pharma,

3;

J. J. Cush,

UCB Pharma,

5.

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