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Published on: July 7, 2017
Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study
Donald A Mahler1, Saling Huang, Mohammad Tabrizi
1Section of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756-0001, USA. Donald.a.mahler@hitchcock.org
Insights
This study found that a monoclonal antibody targeting interleukin-8 (IL-8) improved shortness of breath in COPD patients. Further research is recommended for this IL-8 therapy in COPD treatment.
Area of Science:
- Pulmonology
- Immunology
- Clinical Trials
Background:
- Chronic Obstructive Pulmonary Disease (COPD) is a significant respiratory illness.
- Interleukin-8 (IL-8) plays a role in the inflammatory processes of COPD.
Purpose of the Study:
- To evaluate the efficacy and safety of a fully human monoclonal antibody against IL-8 in COPD patients.
- To determine if IL-8 neutralization can improve COPD symptoms.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 109 stable COPD patients.
- Patients received monthly IV infusions of the anti-IL-8 monoclonal antibody or placebo over 3 months.
Main Results:
- The anti-IL-8 antibody group showed a greater improvement in the Transition Dyspnea Index (TDI) score compared to placebo.
- A higher proportion of patients receiving the antibody achieved a clinically significant improvement in dyspnea.
Conclusions:
- Neutralizing IL-8 with monoclonal antibody therapy shows potential for improving dyspnea in COPD.
- These findings support further investigation of IL-8 targeted therapies for COPD.
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 IgG(2) 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.