CURRENT ADR NETWORK REPORT

Hearing loss with secukinumab (COSENTYX)?

A rheumatologist prescribes the interleukin inhibitor, secukinumab (COSENTYX), to treat a 57 year-old woman with psoriatic arthritis. During the three-month treatment period which comprised initially weekly injections of 150 mg and 150 mg every four weeks thereafter, flu-like symptoms with tonsillitis, otalgia and headache developed, followed by bilateral otitis externa, granulating otitis media with effusion, subtotal tympanic membrane perforation and, ultimately, inner ear damage with unilateral hearing loss and impaired balance (NETZWERK report 17.385). According to the Summary of Product Characteristics (SPC; 1), secukinumab increases the risk of infection with very common upper respiratory tract infections, e.g. nasopharyngitis and, uncommon, otitis externa. In clinical trials involving psoriasis patients otitis media has also been reported following administration of the 300 mg dose indicated for the treatment of psoriasis. Ear infections were generally more common following administration of the 300 mg dose compared to the 150 mg dose (2). The WHO (3) currently has a total of 24,729 reports of suspected adverse drug reactions to secukinumab on file, including 101 reports of ear infections, 11 relating to otitis media, 9 to otitis externa, 5 to perforated eardrum and 1 each to acute otitis media and labyrinthitis. Given the potential risk of permanent hearing impairment, we believe that greater attention should be paid to ear disorders developing during treatment with the interleukin inhibitor.

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