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The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects after the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment dupixent (dupilumab).
While Dupixent is already associated with rare cases of conjunctivitis and allergic conjunctivitis, dry eye and keratitis, and ulcerative keratitis, the MHRA asks health professionals to be alert for any of these eye-related side effects because “they are rare and It is currently not possible to predict who may experience the most serious ocular adverse reactions.”
Despite the new warning, expert ophthalmology and dermatology advice provided to the MHRA shows that most eye reactions seen with dupilumab are mild and manageable.
“Therefore, it is important for patients with all ocular reactions to receive prompt care, with appropriate treatment provided to prevent or minimize eye damage. It is important to recognize ‘red flags’ for immediate ophthalmological consultation such as eye pain, loss of vision and increased eye pressure,” said the MHRA.
Blockbuster Dupixent was first licensed in the UK in September 2017 for moderate to severe atopic dermatitis and as an add-on maintenance treatment for severe asthma in people over 12 years of age.
As of September 7, the MHRA says it has received 479 UK reports involving suspected eye side effects from dupilumab. Of these, 111 reports were considered serious, the MHRA noted that nine reports of ulcerative keratitis were received, representing five cases, and two of these cases involved corneal perforation. 18 reports involved children between the ages of 6 and 17.
But UK regulators have also noted that it is often not necessary to stop treatment, noting:
UK clinical experience is that dupilumab treatment usually does not need to be discontinued in case of ocular reactions. It is important for the patient to receive timely advice and intervention with appropriate care and management of ocular reactions and for patients and healthcare professionals to recognize serious reactions, and when ophthalmological referral is necessary.
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