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Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial.
Arthritis Rheum 2002; 46(12):3251-8AR

Abstract

OBJECTIVE

To evaluate the safety and efficacy of a humanized monoclonal antibody against CD154 (IDEC-131) in patients with active systemic lupus erythematosus (SLE).

METHODS

In this phase II, double-blind, placebo-controlled, multiple-center, multiple-dose study, 85 patients with mild-to-moderately active SLE were randomized to receive 6 infusions of IDEC-131, ranging from 2.5 mg/kg to 10.0 mg/kg, or placebo over 16 weeks. Efficacy was assessed at week 20, primarily by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and secondarily, by multiple measures of disease activity. Safety was assessed through week 28 by clinical and laboratory evaluation. Immunogenicity studies were also performed.

RESULTS

SLEDAI scores improved from the baseline levels of disease activity in all groups, including the placebo group. However, these scores were not statistically different among the IDEC-131 treatment and placebo groups at week 20. Evaluations of secondary variables did not indicate significant differences between the IDEC-131 treatment and placebo groups. The type and frequency of adverse events were similar between the IDEC-131 and placebo groups.

CONCLUSION

IDEC-131 administered at doses ranging 2.5-10.0 mg/kg over 16 weeks was safe and well tolerated in patients with SLE. Efficacy of the drug compared with placebo was not demonstrated. There were statistically significant improvements from baseline in all groups, including the placebo group.

Authors+Show Affiliations

University of California, Los Angeles School of Medicine, USA. kkalunian@mednet.ucla.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

12483729

Citation

Kalunian, Kenneth C., et al. "Treatment of Systemic Lupus Erythematosus By Inhibition of T Cell Costimulation With anti-CD154: a Randomized, Double-blind, Placebo-controlled Trial." Arthritis and Rheumatism, vol. 46, no. 12, 2002, pp. 3251-8.
Kalunian KC, Davis JC, Merrill JT, et al. Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2002;46(12):3251-8.
Kalunian, K. C., Davis, J. C., Merrill, J. T., Totoritis, M. C., & Wofsy, D. (2002). Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial. Arthritis and Rheumatism, 46(12), pp. 3251-8.
Kalunian KC, et al. Treatment of Systemic Lupus Erythematosus By Inhibition of T Cell Costimulation With anti-CD154: a Randomized, Double-blind, Placebo-controlled Trial. Arthritis Rheum. 2002;46(12):3251-8. PubMed PMID: 12483729.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial. AU - Kalunian,Kenneth C, AU - Davis,John C,Jr AU - Merrill,Joan T, AU - Totoritis,Mark C, AU - Wofsy,David, AU - ,, PY - 2002/12/17/pubmed PY - 2003/1/11/medline PY - 2002/12/17/entrez SP - 3251 EP - 8 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 46 IS - 12 N2 - OBJECTIVE: To evaluate the safety and efficacy of a humanized monoclonal antibody against CD154 (IDEC-131) in patients with active systemic lupus erythematosus (SLE). METHODS: In this phase II, double-blind, placebo-controlled, multiple-center, multiple-dose study, 85 patients with mild-to-moderately active SLE were randomized to receive 6 infusions of IDEC-131, ranging from 2.5 mg/kg to 10.0 mg/kg, or placebo over 16 weeks. Efficacy was assessed at week 20, primarily by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and secondarily, by multiple measures of disease activity. Safety was assessed through week 28 by clinical and laboratory evaluation. Immunogenicity studies were also performed. RESULTS: SLEDAI scores improved from the baseline levels of disease activity in all groups, including the placebo group. However, these scores were not statistically different among the IDEC-131 treatment and placebo groups at week 20. Evaluations of secondary variables did not indicate significant differences between the IDEC-131 treatment and placebo groups. The type and frequency of adverse events were similar between the IDEC-131 and placebo groups. CONCLUSION: IDEC-131 administered at doses ranging 2.5-10.0 mg/kg over 16 weeks was safe and well tolerated in patients with SLE. Efficacy of the drug compared with placebo was not demonstrated. There were statistically significant improvements from baseline in all groups, including the placebo group. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/12483729/Treatment_of_systemic_lupus_erythematosus_by_inhibition_of_T_cell_costimulation_with_anti_CD154:_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1002/art.10681 DB - PRIME DP - Unbound Medicine ER -