Dupilumab - risk of ocular adverse reactions and need for prompt management

Dupilumab - risk of ocular adverse reactions and need for prompt management

• dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signalling
• in the UK
  • for adults and adolescents older than 12 years, it is licensed for use in moderate to severe atopic dermatitis and as add-on maintenance treatment for severe asthma
  • for adults, it is also licensed as an add-on therapy with intranasal corticosteroids for severe chronic rhinosinusitis with nasal polyposis
• potential for adverse reactions affecting the eye with dupilumab was established in the initial clinical trials
  • further ocular adverse reactions have been identified during post-marketing clinical use
  • although most ocular reactions are mild, some can become serious

Advice for healthcare professionals:

• dupilumab is commonly associated with cases of conjunctivitis and allergic conjunctivitis, eye pruritus, blepharitis, and dry eye and with infrequent cases of keratitis and ulcerative keratitis, especially in patients with atopic dermatitis
• be alert to the risks of ocular reactions and promptly review new onset or worsening ocular symptoms, referring patients for ophthalmological examination as appropriate
• sudden changes in vision or significant eye pain that does not settle warrant urgent review
• discuss with patients or caregivers the potential for, and symptoms of, ocular side effects at initiation of dupilumab, including symptoms of conjunctivitis and dry eye (which can also include paradoxical eye watering), keratitis and ulcerative keratitis
• advise patients to promptly report new-onset or worsening eye symptoms to their healthcare professional so that appropriate treatment can be initiated – advise patients not to self-manage ocular symptoms
• ensure that patients who develop conjunctivitis or dry eye that does not resolve following initial treatment, or patients with signs and symptoms suggestive of keratitis (especially eye pain and vision changes), undergo ophthalmological examination, as appropriate
• a UK expert consensus-based guidance on the management of people with dupilumab-related ocular surface disorders is currently being developed by relevant national specialty organisations
• we remind healthcare professionals that tralokinumab, another interleukin-13 inhibitor recently licenced for use in atopic dermatitis, is also associated with common cases of conjunctivitis and allergic conjunctivitis as well as uncommon cases of keratitis, and that patients treated with tralokinumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination
• report any suspected adverse drug reactions associated with dupilumab or tralokinumab on a Yellow Card

Reference:

• MHRA. Dupilumab - risk of ocular adverse reactions and need for prompt management. Drug Safety Update volume 16, issue 4: November 2022: 1.