Background/Purpose:  Autoimmune Inner Ear Disease (AIED) is characterized by rapidly progressive sensorineural hearing loss accompanied by tinnitus, with or without vertigo, which may progress to deafness if untreated. While corticosteroid (CS) therapy may be effective in 50-70% of cases, there is often difficulty in tapering CS without decline in hearing and there are significant associated side effects. Multiple immunosuppressive regimens have been used with mixed results. A recent open label trial demonstrated intratympanic (TM) Golimumab, a tumor necrosis-α inhibitor, to be effective in stabilizing hearing loss and allow 7 of 10 long-term CS-dependent patients to completely taper off of prednisone. In this retrospective case series, we report our experience with the use of subcutaneous (SC) Golimumab.

Methods:  Patients were diagnosed by experienced Otologists at House Ear Clinic and followed by Rheumatology at Cedars-Sinai for co-management of immunomodulatory therapy, from January 2013 to April 2016. Medication lists and hearing tests were reviewed throughout treatment with off-label SC Golimumab.

Results:  Five patients were identified with AIED with hearing loss initially responsive to CS and difficulty with sustaining hearing with taper. There were 3 male and 2 female patients, with a mean age of 57.4. In 2 patients, 1 male and 1 female, there was previous success with steroid taper and hearing stability during the TM Golimumab trial in 2012. Patient 1 was steroid dependent (30 mg QD) for 7 years prior to trial and was able to taper off. Once hearing declined after 15 months, she was started on SC Golimumab. She continues to be maintained off steroids and showed improvement in left ear word recognition scores. Patient 2 was able to taper off steroids in the TM trial. He needed to restart steroids 16 months after trial at 60 mg due to worsening hearing loss and tinnitus. He started SC Golimumab and was able to taper off steroids within 13 months with improvements in both hearing loss and tinnitus. Patient 3 required steroids off and on for 8 years due to hearing loss and severe attacks of vertigo. When he started SC Golimumab he was on Prednisone 20 mg and was able to taper to 4 mg in 11 months, with improvement in speech recognition in both ears. He has been free of severe vertigo attacks, now with only mild episodes. Patient 4 had symptoms of hearing loss, tinnitus and vertigo and was on Prednisone 11 mg when she started SC Golimumab. She was able to taper off completely within 12 months, with improvement in speech discrimination score in both ears and improvement in all her symptoms. Patient 5 was on and off steroids for several years due to hearing loss and vertigo. After initiation of SC Golimumab, he noted increase in speech recognition in the 2^ndmonth of therapy, improvement in vertigo and has been maintained off steroids. Golimumab was well-tolerated in all patients without significant complications or side effects to date.

Conclusion:  The preliminary data suggests that treatment with SC Golimumab may be considered a therapeutic option for patients with AIED, and is useful as a steroid-sparing agent. Larger studies are warranted to further explore the therapeutic potential of Golimumab in AIED.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/use-of-subcutaneous-golimumab-in-autoimmune-inner-ear-disease/