UK’s MHRA Issues Warning to Providers Over Dupilumab Ocular Adverse Reactions

By Jeff Craven, MD /alert Contributor
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The UK’s Medicines and Healthcare Regulatory Agency (MHRA) is warning healthcare providers to be on the lookout for ocular adverse reactions in their patients taking dupilumab and report any new or worsening ocular adverse reactions.

Dupilumab is currently used as a treatment for severe asthma or severe atopic dermatitis in children 6 years and older and as a treatment for moderate-to-severe atopic dermatitis in adolescents 12 years and older in the US, UK, and in other countries. While ocular adverse reactions from taking dupilumab are a known side effect identified in the clinical trials that led to its approval and in post marketing studies, some patients with worsening symptoms can develop ulcerative keratitis with serious corneal damage, the regulator said.

“It is not currently possible to predict who may experience the rarer and most serious ocular adverse reactions, such as ulcerative keratitis. It is therefore important, with all ocular reactions, for patients to receive prompt care, with treatment provided as appropriate to prevent or minimise damage to the eye,” MHRA said in its statement to providers.

In total, the MHRA received 479 reports of ocular side effects from dupilumab up to September 2022, which included 111 serious reports, including 9 cases of ulcerative keratitis in 5 patients. According to the dupilumab product information, conjunctivitis, and allergic conjunctivitis are considered common (1 in 10 patients), while side effects such as dry eye, blepharitis, eye pruritus, and keratitis are considered uncommon (1 in 1,000 patients).

Although MHRA has received no current reports, the regulator is asking healthcare providers to also monitor patients taking tralokinumab, another monoclonal antibody that inhibits IL-13 signaling and carries risks of conjunctivitis and keratitis. MHRA is urging patients who take either of these medications to recognize signs of new or worsening eye pain, vision loss, and an increase in ocular pressure as a need for urgent ophthalmological consultation, as most dupilumab ocular reactions can be managed. The regulator also noted they are currently creating expert-based consensus guidelines on dupilumab-related ocular surface disorder management.

“UK clinical experience is that dupilumab treatment does not usually need to be discontinued in the event of ocular reactions,” MHRA wrote. “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 recognise serious reactions, and when ophthalmological referral is necessary.”


Disclosures: MD /alert could not confirm financial disclosures at the time of reporting.

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