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Abstract Number: 1856

Burden of Adverse Events Associated with Immunosuppressant Therapy for the Treatment of Systemic Lupus Erythematosus: A Systematic Literature Review

Alan Oglesby1, Arthur Weinstein2, Greg Dennis3, Alissa Shaul4, Tiffany Pokora4, Clark Paramore5, Lael Cragin6 and Siva Narayanan7, 1GlaxoSmithKline, Research Triangle Park, NC, 2Washington Hospital Center, Washington, DC, 3Human Genome Sciences, Inc., Rockville, MD, 4United BioSource Corporation, Bethesda, MD, 5United BioSource Corporation, Lexington, MA, 6United BioSource, Bethesda, MD, 7Global Health Economics and Outcomes Research and Epidemiology, Human Genome Sciences, Inc., Rockville, MD

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Adverse events and systemic lupus erythematosus (SLE)

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Session Information

Session Title: Epidemiology and Health Services Research: Rheumatic Disease Pharmacoepidemiology

Session Type: Abstract Submissions (ACR)

Background/Purpose: Past systematic literature reviews on adverse events (AEs) associated with immunosuppressants in patients with systemic lupus erythematosus (SLE) focused mostly on cyclophosphamide (oral: CYC; IV: IVC) and mycophenolate mofetil (MMF). The aim of this research is to quantify the incidence of AEs, identify discontinuation rates due to AEs and resource use and cost associated with AEs from CYC/IVC, MMF, azathioprine (AZA), methotrexate (MTX), and cyclosporine (CsA) in SLE patients.

Methods: A systematic review of English-language, MEDLINE- and EMBASE-indexed literature published between January 1980 and September 2011 was conducted using terms related to SLE, AEs, discontinuation, resource use and costs. After excluding case reports, case series, non-systematic reviews, studies of fewer than 50 patients, and articles without abstracts, 38 eligible non-review articles were identified (14 randomized controlled trials (RCTs) & 22 observational studies (OBS); results are presented here.

Results: The development of AEs ranged from 42.8% to 97.3%. Commonly noted AEs are shown in the table. Discontinuation rates due to AEs were 1.4-13% in short-term (<12 months) RCTs, 2.3–44.4% in long-term (>12 months) RCTs, and 0–21.8% in OBS. Eight studies reported resource use in terms of hospitalizations due to AEs; however, frequency measures used to report hospitalization varied among the studies resulting in an inability to make comparisons between studies. No studies reported costs associated with AEs.

 

Summary of Commonly Reported AEs by Intervention

 

>1 AE

Infections

GI

Amenorrhea and/or Ovarian Complications

Hematological

Death

AZA

 

 

 

 

 

 

RCTs (n=7)

NA

2.4-42.4%

3.2-21.4%

8.0-36.0%

6.0-50.0%

0.0-25.0%

OBS (n=3)

NA

NA

1.3%

1.4-5.6%

16.7%

NA

IVC

 

 

 

 

 

 

RCTs (n=8)

95.0%

11.8-77%

29.4-66.7%

2.2-56.3%

1.4-38.7%

2.7-20%

OBS (n=13)

57.5-65.0%

12.5-67.9%

18-58.8%

1.9-58%

2.5-7.7%

3.0-20%

Oral CYC

 

 

 

 

 

 

RCTs (n=3)

NA

33-40%

3.2%

36.0-71.0%

25.8%

6.5-22.2%

OBS (n=5)

NA

26-61%

7.0%

28.0-37.0%

7.0%

NA

CsA

 

 

 

 

 

 

RCTs (n=2)

NA

6.4-19.4%

17.0-30.6%

N/A

11.1-38.3%

4.3%

OBS (n=1)

62.5%

NA

3.9%

NA

NA

NA

NA: Not Available

 

 

 

 

 

 

MTX

 

 

 

 

 

 

RCTs (n=1)

93.0%

4.9%

56.1%

NA

26.8%

NA

OBS (n=0)

NA

NA

NA

NA

NA

NA

MMF

 

 

 

 

 

 

RCTs (n=5)

96.2-97.3%

12.5-68.5%

9.1-61.4%

0-6%

0.0-21.7%

1.9-5.0%

OBS (n=5)

42.8-66.7%

3.9-44.4%

4.2-38.9%

NA

0.5-5.6%

NA

 

Conclusion: The development of AEs associated with immunosuppressant medications in SLE patients was consistently high as reported in the SLE literature, while discontinuation due to these AEs varied from 0% to 44%. Studies describing costs and resource use associated with these AEs were sparse and warrant further study.


Disclosure:

A. Oglesby,

GlaxoSmithKline,

1,

GlaxoSmithKline,

3;

A. Weinstein,

HGS, Genentech, Savient, Pfizer,

2,

HGS, GSK, Pfizer,

5,

HGS, GSK,

8;

G. Dennis,

Human Genome Sciences, Inc. ,

1,

Human Genome Sciences, Inc.,

3;

A. Shaul,

United BioSource Corporation,

3;

T. Pokora,

United BioSource Corporation,

3;

C. Paramore,

United Biosource Corporation,

3;

L. Cragin,

United BioSource Corporation,

3;

S. Narayanan,

Human Genome Sciences, Inc. ,

1,

Human Genome Sciences, Inc. ,

3.

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