Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement

Atsuki Fukushima, Yuichi Ohashi, Nobuyuki Ebihara, Eiichi Uchio, Shigeki Okamoto, Naoki Kumagai, Jun Shoji, Etsuko Takamura, Yayoi Nakagawa, Kenichi Namba, Hiroshi Fujishima, Dai Miyazaki, Atsuki Fukushima, Yuichi Ohashi, Nobuyuki Ebihara, Eiichi Uchio, Shigeki Okamoto, Naoki Kumagai, Jun Shoji, Etsuko Takamura, Yayoi Nakagawa, Kenichi Namba, Hiroshi Fujishima, Dai Miyazaki

Abstract

Background: The objective of this study was to investigate the efficacy of topical 0.1% tacrolimus in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement.

Methods: This prospective observational study included 1436 patients with refractory allergic conjunctivitis whose condition had responded poorly to conventional antiallergic drugs and/or topical steroids and/or topical cyclosporine. All patients received tacrolimus eye drops twice daily during the study period. Ten clinical signs and six clinical symptoms were rated on a four-grade scale. The primary endpoint was the change from baseline in total clinical signs and symptoms score at the last observation or following 6 months of treatment.

Results: Total signs and symptoms score significantly decreased after 1 month of treatment (p<0.001). Giant papillae and corneal lesions were also reduced by tacrolimus eye drop use (p<0.001). The drug proved effective in patients whose condition did not respond well to topical cyclosporine therapy. About 50% of all patients using topical steroids were weaned. The most common adverse reaction was a transient burning sensation (3.20%).

Conclusions: Tacrolimus eye drops are highly effective in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement, and may reduce or replace topical steroid use.

Trial registration number: UMIN 000008640.

Keywords: Conjunctiva; Drugs; Immunology; Inflammation; Treatment Medical.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Change from baseline in total symptom and sign scores during the 6-month study period (n=1436 patients). Error bars represent 1 SD. The statistical significance of each score change was evaluated using the Wilcoxon signed rank test.
Figure 2
Figure 2
Distribution of giant papillae (A) and corneal involvement (B) scores. The statistical significance of each score change from baseline was evaluated using the Wilcoxon signed rank test.
Figure 3
Figure 3
Changes from baseline in total sign and symptom scores in patients who did not respond well to prior cyclosporine ophthalmic solution therapy. Error bars represent 1 SD. The statistical significance of each score change was evaluated using the Wilcoxon signed rank test.
Figure 4
Figure 4
Proportions of patients using topical steroids at baseline and throughout the 6-month period during which the patients received topical tacrolimus eye drops.

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Source: PubMed

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