Adalimumab effective but not a cure for uveitis
Adalimumab (Humira, AbbVie), an immunosuppressive biologic therapy, improves the symptoms of non-infectious active uveitis, but causes some adverse events and does not cure the disease, according to researchers.
Median time to treatment failure was 24 weeks in a group of patients treated for uveitis with adalimumab compared with 13 weeks in a matched group treated with a placebo.
Used for years in rheumatoid arthritis and other autoimmune disorders, adalimumab gained approval in May from the European Medicines Agency (EMA) for use in non-infectious intermediate and posterior uveitis and panuveitis in adult patients who can’t be treated effectively with corticosteroids. It received similar approval in June from the US Food and Drug Administration (FDA).
Now researchers from Europe and the USA have published in the New England Journal of Medicine one of the clinical trials that led to these approvals.
Clinicians have long relied on corticosteroids to treat uveitis. These treatments frequently cause ocular and systemic adverse events, so immunosuppressant therapies have emerged as an alternative, or second-line therapy. But few randomised controlled trials have examined their safety and efficacy.
Some research has suggested that the proinflammatory cytokine tumour necrosis factor alpha (TNF-alpha) has a role in uveitic inflammation. Serum and aqueous humour levels of TNF-alpha are up-regulated in patient with uveitis.
A fully human anti-TNF-alpha monoclonal antibody, adalimumab effectively lowers inflammation in multiple other disorders.
Related: Clinical pearls for treating uveitis
The researchers wanted to see how well the medication could work in patients with uveitis. They recruited patients in 18 countries and randomly assigned 110 to treatment with adalimumab and 107 to a placebo.
57% of the patients were women, 80% were white, and 45% had a diagnosis of panuveitis. Their mean age was 42.7 years, and the mean duration of their uveitis was 46 months.
There were no significant demographic differences between the two groups, and their exposure to glucocorticoids was similar.