This work was performed in the Division of Otolaryngology–Head and Neck Surgery, Penn State Hershey Medical Center, Hershey, Pennsylvania, U.S.A.
Round window membrane permeability to golimumab in guinea pigs: A pilot study
Article first published online: 25 JUN 2013
Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.
Volume 123, Issue 11, pages 2840–2844, November 2013
How to Cite
Ghossaini, S. N., Liu, J. P. and Phillips, B. (2013), Round window membrane permeability to golimumab in guinea pigs: A pilot study. The Laryngoscope, 123: 2840–2844. doi: 10.1002/lary.24163
Golimumab was donated by Janssen Biotech.
This study was supported by a generous grant from the department of Surgery at Penn State Hershey Medical Center, Hershey, Pennsylvania, U.S.A.
The authors have no other funding, financial relationships, or conflicts of interest to disclose.
- Issue published online: 28 OCT 2013
- Article first published online: 25 JUN 2013
- Manuscript Accepted: 27 MAR 2013
- Manuscript Revised: 25 MAR 2013
- Manuscript Received: 2 FEB 2013
- Autoimmune inner ear disease;
- round window membrane permeability;
- tumor necrosis factor-α;
Autoimmune inner ear disorder is one of a few types of sensorineural hearing loss that is treatable and potentially reversible. Treatment involves oral steroids and methotrexate. Other treatment modalities have been tried with variable success. All such treatments are systemic, with inherent side effects limiting their effectiveness. Recently, tumor necrosis factor (TNF)-α blockers have been suggested as a modality of treatment. The objective of this study was to assess the round window membrane permeability to golimumab, a TNF-α blocker. This study is the first to look at the feasibility of local golimumab delivery into the inner ear, which may allow for targeted immune modulation of autoimmune inner ear disorders without the consequences of systemic treatment.
This is a single-blinded, placebo-controlled, pilot study using guinea pigs to assess round window membrane permeability to golimumab.
Golimumab was instilled into the guinea pigs' middle ear. Inner ear fluid was sampled through the round window membrane after approximately 30 minutes of drug exposure. Golimumab presence in the inner ear was assessed by enzyme-linked immunosorbent assay in both drug-treated and control ears.
Higher concentrations of golimumab were detected in the inner ear fluid samples of golimumab-exposed ears than in the control ears. The difference was statistically significant (P < .001).
Golimumab crosses the round window membrane and is detected in measurable concentrations in the inner ear fluid after 30 minutes of exposure to the membrane. Further studies are needed to learn its pharmacokinetics and the time needed to reach optimal concentration in the inner ear.
Level of Evidence
NA. Laryngoscope, 123:2840–2844, 2013