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Preliminary Reports |

Efficacy and Safety of a Monoclonal Antibody Recognizing Interleukin-8 in COPD*: A Pilot Study

Donald A. Mahler, MD, FCCP; Saling Huang, PhD; Mohammad Tabrizi, PhD; Gregory M. Bell, MD
Author and Funding Information

*From Dartmouth Medical School (Dr. Mahler), Lebanon, NH; and Abgenix, Inc. (Drs. Huang, Tabrizi, and Bell), Fremont, CA.

Correspondence to: Donald A. Mahler, MD, FCCP, Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756-0001; e-mail: Donald.a.mahler@hitchcock.org



Chest. 2004;126(3):926-934. doi:10.1378/chest.126.3.926
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Study objective: To investigate the efficacy and safety of a fully human monoclonal antibody recognizing the chemokine interleukin (IL)-8 in patients with COPD.

Design: Randomized, double-blind, parallel-group, placebo-controlled trial.

Setting: Eighteen clinics/hospitals in the United States.

Patients: One hundred nine patients with stable COPD.

Interventions: Three IV infusions of either monoclonal antibody recognizing IL-8 (800-mg loading dose; 400-mg subsequent doses) or active buffer solution administered monthly over a 3-month period.

Measurements and results: The differences in the transition dyspnea index (TDI) total score, the primary outcome measure, between fully human monoclonal IgG2 antibody directed against IL-8 and placebo were 0.8, 1.0, 0.8, and 0.3 at week 2 (p = 0.046) and months 1 to 3, respectively. At all time points, the proportion of patients achieving ≥ 1 point improvement in the TDI was greater for the monoclonal antibody group compared with the placebo group: 28% vs 11% at week 2 (p = 0.028). There were no significant differences observed for lung function, health status, 6-min walking distance, and adverse events between groups.

Conclusions: The results of this phase 2 study suggest that neutralization of IL-8 with monoclonal antibody therapy may improve dyspnea in patients with COPD. These results support the further investigation of monoclonal antibody therapy targeting IL-8 for the treatment of this disease.

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