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Tacrolimus may be used to treat shield ulcers, epitheliopathy without adjuvant steroids

Jairia Dela Cruz
16 Jan 2017

Topical tacrolimus appears to be effective against shield ulcers and corneal epitheliopathy, successfully treating patients even without adjuvant steroids, according to data from an open cohort study.

The strong potency of the topical drug that allows treatment without steroids is beneficial for the long-term management of refractory inflammatory ocular surface diseases, researchers said. “[Furthermore] the complications associated with steroid use can be eliminated.”

In a cohort of 791 refractory allergic conjunctivitis patients with epitheliopathy or shield ulcers, the addition of topical or oral steroid to tacrolimus produced a small and insignificant effect.

After 1 month of treatment, corneal epitheliopathy scores improved in all patients treated with tacrolimus alone or in combination with topical steroids with no significant intergroup differences. The scores declined from 1.73 at baseline to 0.81 with tacrolimus alone (p=0.000), 1.75 to 0.80 with adjuvant fluorometholone, and 1.83 to 0.91 with adjuvant betamethasone. Receipt of oral steroids showed no significant benefit. [Ophthalmology 2016;doi:10.1016/j.ophtha.2016.11.002]

The calculated reductions induced by steroids in epitheliopathy scores were −0.02 for fluorometholone, 0.02 for betamethasone and −0.02 for oral steroids vs −0.93 with tacrolimus alone.

In patients with shield ulcer (score 3) particularly, the adjusted mean epitheliopathy score at 1 month decreased to 1.38 with tacrolimus alone, 1.41 with adjuvant fluorometholone and 1.46 with adjuvant betamethasone. There was no significant difference.

Researchers said such scores indicated that the presence of severe palpebral conjunctival symptoms, including giant papillae, was a significant resisting factor for topical tacrolimus.

“Topical steroids did not significantly affect the time course after adjustment of these factors during the treatment course. In addition, such resisting clinical symptoms themselves are generally refractory to topical steroids; however, topical tacrolimus significantly mitigated such signs, although it required several months. This may explain why topical steroids did not have significant additive effects,” they continued.

The mean age of the study cohort was 15.9, with majority being male (82.8 percent) and 30.09 percent having shield ulcers. Of the patients, 337 were treated with tacrolimus alone and the remaining 454 received adjuvant topical steroids. Oral steroid use was reported by 2.3 percent.

Despite the absence of significant additive effect with adjunctive topical steroid use, there is no indication in the findings that topical steroids are completely unnecessary for successful treatment, researchers said.

“For example, tacrolimus eye drops often cause a stinging sensation or conjunctival redness, especially in the beginning of treatment of severely inflamed eyes. This can be avoided by topical steroid pretreatment before the use of topical tacrolimus,” they added.

Dr Marcus Ang from the Corneal and External Eye Disease Department at the Singapore National Eye Centre and who was not involved in the study told MIMS that the steroid-sparing effect of tacrolimus was a welcome addition to the therapeutic options of clinicians for patients with severe allergic keratoconjunctivitis who might require long-term steroids.

“[Steroid dependence increases] the risk of complications such as secondary raised intraocular pressure, glaucoma and cataracts,” Dr Ang explained.

He also pointed out that in the study, it was suggested that while tacrolimus might be used without steroids in patients with severe epitheliopathy, the topical drug might not have any other effects on the disease such as papillae.

“Steroids remain the mainstay of treatment, while tacrolimus may be a useful steroid-sparing agent,” Dr Ang said.

Given that some patients may require long-term steroids, clinicians need to closely monitor them for complications such as glaucoma, he added.

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