SAFETY RESULTS FROM A RCT OF LJP 394 IN SLE PATIENTS WITH A HISTORY OF RENAL DISEASE

Daniel J Wallace, MD¹, M H Cardiel, MD², J A Tumlin, MD³, R Furie, MD⁴, C Hura, MD⁵, V Strand, MD⁶, S Wang, PhD⁷, I Yushmanova, MD⁷ and K R Heilbrunn, MD⁷.

¹ Research, Wallace Rheumatic Study Center, Los Angeles, CA, United States
² Depto. Inmunology Y Rheumatology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, CP, Mexico
³ Renal Division, Emory University, Atlanta, GA, United States
⁴ Rheumatology, No. Shore University Hospital, Manhasset, NY, United States
⁵ Research Dept., San Antonio Kidney Disease Ctr., San Antonio, TX, United States
⁶ Stanford University, Palo Alto, CA, United States
⁷ La Jolla Pharmaceutical Co., San Diego, CA, United States

Purpose:
To assess the safety and efficacy of LJP 394 in the treatment of SLE patients (pts) with a history of renal disease.

A multi-center, phase 3 RCT was conducted to compare weekly IV infusions of 100 mg LJP 394 or placebo (PBO) in SLE pts with a history of renal disease for up to 22 months. Safety analyses included assessment of adverse events (AE's), changes in lab parameters and vital signs in all 317 randomized pts (158 LJP 394, 159 PBO).

Baseline characteristics were similar between treatment groups. Mean duration of treatment exposure was 315 days in LJP 394 group and 336 days in PBO group. There were no differences in the overall incidence of AE's or serious adverse events (SAE's) between both groups. AE's were reported in 139 (88.0%) pts receiving LJP 394 and 142 (89.3%) pts receiving PBO. SAE's were reported in 62 pts: LJP 394: 30(19.0%); PBO: 32(20.1%). Three SAE's were considered possibly related to study drug, 2 LJP 394 (angioedema and nephritis); 1 PBO (fever). Four deaths were reported during treatment or within 30 days of discontinuing study drug, 3 LJP 394 (2 sepsis, 1 pneumonia) and 1 PBO (sepsis). Types and severity of reported AE's were similar between treatment groups. 8 pts in each group discontinued study drug due to AE's, abnormal labs or deterioration in clinical status. Changes from baseline in lab parameters and vital signs in LJP 394 and PBO treated pts were comparable.

In both treatment groups, 83% pts were receiving prednisone 20 mg/day at baseline; in the LJP 394 and PBO groups, 48% and 42%, respectively, were taking other immunosuppressive agents at baseline.

Weekly intravenous administration of LJP 394 100 mg was well tolerated for up to 22 months in SLE pts with a history of renal disease.

Presented at the
36th Annual Meeting of the American Society of Nephrology
San Diego, CA
November 12-17, 2003