6/10/2023 0 Comments Pixen for windows![]() ![]() Clinical trial data have indicated that keratitis, conjunctivitis and allergic conjunctivitis are associated with tralokinumab use. To date, there is very limited UK clinical experience with its use. Tralokinumab, an antibody that inhibits interleukin-13 signalling, has more recently been licenced in the UK for moderate-to-severe atopic dermatitis in adult patients. We are also alerting healthcare professionals prescribing tralokinumab. 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. It is not currently possible to predict who may experience the rarer and most serious ocular adverse reactions, such as ulcerative keratitis. The review recommended that updates should be made to the product information for dupilumab to include the adverse drug reaction ‘dry eye’ and also to emphasise the need for prompt and appropriate management of any potential ocular reactions. We sought independent advice from the Gastroenterology, Rheumatology, Immunology and Dermatology Expert Advisory Group to the Commission on Human Medicines, as well as ophthalmology expertise. We recently reviewed the risk of dry eye and also serious ocular side effects associated with dupilumab. We have received a small number of Yellow Card reports of ulcerative keratitis with serious corneal damage associated with dupilumab treatment. Although most ocular reactions are mild, some can become serious. Further ocular adverse reactions have been identified during post-marketing clinical use. ![]() The potential for adverse reactions affecting the eye with dupilumab was established in the initial clinical trials. if you experience significant eye pain that does not settle, or changes in your vision, it is important to speak to your doctor without delayĭupilumab is a monoclonal antibody that inhibits interleukin-4 and interleukin-13 signalling and is used in moderate to severe atopic dermatitis in adults and adolescents 12 years and older.ĭupilumab is also used in children aged 6 years and older with severe atopic dermatitis or severe asthma, and in adults with severe asthma (see background section for detailed indication).talk to your doctor or another healthcare professional promptly if you have any new or worsening eye problems, such as watering, itching, redness, swelling, eye dryness, a feeling of gritty eyes, or a sensation of a foreign body in the eye.Do not attempt to self-manage new or worsening eye problems – seek medical help most side effects of the eye are mild, but some can become serious if they are not managed properly.dupilumab has been linked to side effects affecting the eye, especially in patients with atopic eczema (atopic dermatitis).report any suspected adverse drug reactions associated with dupilumab or tralokinumab on a Yellow CardĪdvice for healthcare professionals to give to patients or parents and caregivers:.we remind healthcare professionals that tralokinumab (Adtralza▼), 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.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.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.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.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.sudden changes in vision or significant eye pain that does not settle warrant urgent review.be alert to the risks of ocular reactions and promptly review new onset or worsening ocular symptoms, referring patients for ophthalmological examination as appropriate.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. ![]()
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