Tacrolimus treats steroid-refractory vernal keratoconjunctivitis

A small subset of patients, however, may still require an additional course of topical steroids.

Issue: February 2017

Tacrolimus eye ointment for steroid-refractory vernal keratoconjunctivitis significantly improved symptoms and signs after 12 weeks but did not significantly improve visual acuity, according to a study.

The biggest advantage of tacrolimus is that it does not cause cataracts or glaucoma in patients with vernal keratoconjunctivitis (VKC), so it can be used for prolonged periods of time. In addition, children who are often dependent on steroids or who have steroid-refractory VKC can benefit from tacrolimus treatment, Samrat Chatterjee, MS, told Ocular Surgery News.

“Overall, tacrolimus is a big blessing, and only now has the management of VKC been safer because of the avoidance of steroids. My co-author Dr. Agrawal and I use it in all patients who present with moderate to severe symptoms, and so should others,” Chatterjee said.

Reduced symptom scores

The open-label study enrolled 30 patients with VKC who had not responded to topical corticosteroid treatment for at least 4 weeks. Twenty-three patients were available for outcome analysis at the 12-week follow-up. The research was conducted at MGM Eye Institute in Raipur, a tertiary eye care facility in central India.

The patients were treated with 0.03% tacrolimus eye ointment (Aurolab) three times daily, 0.05% ketotifen eye drops twice daily and preservative-free artificial tears. Symptoms, such as itching, redness and watering, were graded on a four-point scale at enrollment, and the scores were compared after 12 weeks of treatment.

Tacrolimus eye ointment statistically significantly reduced total symptom scores from the mean baseline value of 10.3 to the mean value of 3.8 at 4 weeks (P < .0001) and to 3.4 at 12 weeks (P < .0001). Additionally, scores for redness, watering, itching, discharge and photophobia reduced significantly from baseline to 12-week follow-up visits. The total sign scores improved significantly as well, from a mean score of 8.7 at baseline to 4.0 at 12 weeks (P < .001).

Mean best corrected distance visual acuity improved from 0.19 logMAR at baseline to 0.11 logMAR at 12 weeks, but the difference was not statistically significant. There was no significant change in IOP between baseline and 12 weeks.

Study limitations

Chatterjee noted that the study had limitations.

“Long-term data are not available, and to design a prospective study is difficult because of the follow-up issue. The optimal strength is not known. At the time this study was carried out, 0.03% was the only strength that was available. Later, a 0.1% strength also became available, which we have also used. The latter caused significant stinging, and some patients and children discontinued using it. We did not encounter any discontinuation with the 0.03% strength, which, although it caused stinging, patients usually adapted to it within a week,” he said.

Treatment failure, defined as patients needing additional treatment with corticosteroids, was observed in 17% of patients.

Treatment limitations

Tacrolimus had limitations in treating certain patients in the study, Chatterjee said.

“A certain subset of patients does not respond to it, and I have not been able to identify any particular traits as to why some patients will still require an additional shorter course of topical steroids. Some patients who have been using tacrolimus for a long duration may also relapse, which could be due to tachyphylaxis. In those patients, a short tapering course of steroids over a few weeks helps, and then the patients can be maintained on tacrolimus. Secondly, we have not seen large cobblestone papillae disappear, as reported by some authors. That could depend on dose or duration of use, but my general impression is that tacrolimus is less helpful in those with large papillae,” he said. – by Robert Linnehan

Reference:
Chatterjee S, et al. Cornea. 2016;doi:10.1097/ICO.0000000000000918.

For more information:
Samrat Chatterjee, MS, can be reached at Cornea & Anterior Segment Services, MGM Eye Institute, 5th Mile, Vidhan Sabha Road, Raipur, Chhattisgarh, 493111, India; email: samrat@mgmeye.org.

Disclosure: Chatterjee reports no relevant financial disclosures.