Review Article

Adverse Event Burden, Resource Use, and Costs Associated with Immunosuppressant Medications for the Treatment of Systemic Lupus Erythematosus: A Systematic Literature Review

Table 1

Summary of commonly reported AEs by intervention.

At least 1 AEInfectionsGIAmenorrhea HematologicalDeath
and/or ovarian complications

MMF
 RCTs ( )96.2–97.3%12.5–68.5%9.1–61.4%0–6%0–21.7%1.9–5.0%
 Observational ( ) 42.8–66.7%3.85–44.4%4.2–38.9%N/A0.5–5.6%N/A
MTX
 RCTs ( )93.0%4.9%56.1%N/A26.8%N/A
 Observational ( )N/AN/AN/AN/AN/AN/A
AZA
 RCTs ( )N/A2.4–42.4%3.2–21.4%8–36%6–50%0–25%
 Observational ( ) N/AN/A1.3%1.4–5.6%16.7%N/A
IVC
 RCTs ( )95%11.8–77%29.4–66.7%2.2–56.3%1.4–38.7%2.7–20%
 Observational ( ) 57.5–65%12.5–67.9%18–58.8%1.9–58%2.5–7.7%3.0–20%
Oral CYC
 RCTs ( )N/A33–40%3.2%36–71%25.8%6.5–22.2%
 Observational ( ) N/A26–61%7%28–37%7%N/A
CsA
 RCTs ( )N/A6.4–19.4%17.0–30.6%N/A11.1–38.3%4.3%
 Observational ( ) 62.5%N/A3.9%N/AN/AN/A

AZA: azathioprine; CsA: cyclosporine; CYC: cyclophosphamide; IVC: intravenous cyclophosphamide; MMF: mycophenolate mofetil; MTX: methotrexate; N/A: not available; RCT: randomized controlled trial.