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NICE backs biologic for treating condition that can cause blindness

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A monoclonal antibody and a biodegradable corticosteroid implant have been approved for use by the NHS in England and Wales to treat an inflammatory eye condition that can lead to blindness.

Adalimumab (Humira) and dexamethasone intravitreal implant (Ozurdex) have been recommended as an option for treating non-infectious uveitis in the posterior segment of the eye in adults.

“Uncontrolled uveitis can also lead to irreversible deterioration of vision and ultimately blindness”

Annie Folkard

As a result of new technology appraisal guidance, published on Wednesday, routine treatment for the eye condition was no longer limited to steroids and immunosuppressants.

The National Institute for Health and Care Excellence said there was a “significant unmet need” for both adalimumab and dexamethasone intravitreal implant in treating the condition.

Non-infectious uveitis – caused by abnormal activation of the immune system in the middle part of the eye – can lead to reduced vision or vision loss. It can affect both children and adults and is more common in people with an existing inflammatory or autoimmune condition5.

Symptoms include blurred vision and floaters in the eye, and sometimes pain and redness. It may also lead to complications such as cystoid macular oedema, vitreous haze, cataracts, glaucoma and irreversible retinal damage.

Patients may also have sudden and temporary or progressive and permanent visual impairment. One patient expert told NICE they went blind in one eye within three months of the condition starting and others said it was common for patients to “suffer depression and anxiety and to feel isolated”.

“We finally have a routinely available treatment option”

Jessica Hall

In addition, NICE said it was told by clinicians there was currently no nationally agreed pathway for treating non-infectious uveitis. In practice, systemic steroids were used as a first-line treatment and immunosuppressants were either used alone or with steroids as a second-line.

Annie Folkard, co-founder of the Birdshot Uveitis Society, said: “We are delighted that there is now another treatment option for those adults with severe uveitis who have not responded to other forms of treatment and who are at greatest risk of going blind.

“The effects of uveitis can be devastating,” she said. “Not only can it make everyday tasks very difficult, but uncontrolled uveitis can also lead to irreversible deterioration of vision and ultimately blindness.”

Jessica Hall, eye health policy officer at the charity RNIB, said: “We very much welcome NICE’s recommendations, as we finally have a routinely available treatment option, which has been shown to be safe and effective for those adults most at risk of sight loss.”

Under NICE’s ruling, treatment with adalimumab is permitted where there is active disease, inadequate response or intolerance to immunosuppressants, systemic disease or both eyes are affected, and worsening vision with a high risk of blindness.

Treatment should be stopped if there is new active inflammatory chorioretinal or inflammatory retinal vascular lesions, or both, a two‑step increase in vitreous haze or anterior chamber cell grade or worsening of best corrected visual acuity by three or more lines or 15 letters.

Meanwhile, dexamethasone intravitreal implant is recommended if there is active disease – defined as current inflammation in the eye – and worsening vision with a risk of blindness.

The NHS is now required to comply with the recommendations and make it available for eligible patients in England and Wales within three months of the guidance being published.

However, it noted that the recommendations were not intended to affect NHS treatment started before the guidance was published. Adults having treatment outside these recommendations may continue without change “until they and their NHS clinician consider it appropriate to stop”.

Adalimumab, made by AbbVie, is a monoclonal antibody that reduces inflammation by inhibiting pro-inflammatory cytokine tumour necrosis factor-alpha.

Dexamethasone intravitreal implant, produced by Allergan, is a biodegradable corticosteroid implant that suppresses inflammation by inhibiting the expression of pro-inflammatory mediators.

The NICE recommendation for adalimumab is based on efficacy and safety data from two randomised controlled trials, called VISUAL-I and VISUAL-II.

The trials demonstrated that adult patients with either active or controlled non-infectious intermediate, posterior and panuveitis treated with adalimumab had a significantly lower risk for uveitic flare or decrease in visual acuity, compared to placebo.

Meanwhile, the HURON trial showed that dexamethasone had improved outcomes, such as vitreous haze score and visual acuity, compared with a sham procedure, said NICE.

The recommended dose of adalimumab for adults with non-infectious uveitis is an initial dose of 80mg, followed by 40mg every other week starting one week after the initial dose. Adalimumab is given by subcutaneous injection.

Treatment with adalimumab can be started in combination with corticosteroids or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be “tapered off” from two weeks after starting treatment.

The recommended dose of dexamethasone intravitreal implant is one implant, containing 700 micrograms of dexamethasone, to be administered intravitreally to the affected eye. Administration to both eyes concurrently is not recommended.

Repeat doses should be considered when a patient experiences a response to treatment but followed by a loss in visual acuity and, in the clinician’s opinion, may benefit from retreatment without being exposed to significant risk.

Adalimumab costs £704.28 for two pre-filled injections and each dexamethasone intravitreal implant costs £870, according to figures in NICE’s technology appraisal guidance.

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