Session Information
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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