Korean J Ophthalmol.  2012 Aug;26(4):241-247. 10.3341/kjo.2012.26.4.241.

Therapeutic Effect of 0.03% Tacrolimus Ointment for Ocular Graft versus Host Disease and Vernal Keratoconjunctivitis

• Ryu EH
• Kim JM
• Laddha PM
• Chung ES
• Chung TY

• KMID: 1387389
• DOI: http://doi.org/10.3341/kjo.2012.26.4.241

Abstract

PURPOSE
To determine whether topical tacrolimus might prove effective in the treatment of refractory anterior segment inflammatory diseases, and to evaluate its efficacy in eyes with ocular graft versus host disease (GVHD), and vernal keratoconjunctivitis (VKC).
METHODS
Twenty-eight eyes of 14 patients with anterior segment inflammation refractory to steroid treatment were treated with 0.03% tacrolimus ointment at the Samsung Medical Center, Seoul, Korea from March 2008 through August 2009. Seven patients had ocular GVHD and seven had VKC. We evaluated the conjunctival and corneal inflammatory change at one, two, four, and eight weeks after treatment with a scoring system. Time to initial response of treatment and therapeutic effect between GVHD and VKC was also analyzed. After the eight-week treatment period, patients were divided into two groups (maintenance group and discontinuance group). Eight patients maintained the treatment for an additional four months, and six patients discontinued the treatments. Therapeutic effect was also compared between the groups at eight weeks and six months after treatment.
RESULTS
The mean conjunctival and corneal inflammation score was reduced significantly at eight weeks after treatment (p < 0.0001). The therapeutic effect in conjunctival inflammation was first noted at week two after the initial treatment (p = 0.002); reduction in corneal inflammation was first noted at one week (p = 0.0009). When compared according to diagnosis, no therapeutic difference was detected between the groups (p > 0.05). Six months after treatment, we noted no therapeutic differences between the maintenance group and discontinuance group (p > 0.05).
CONCLUSIONS
0.03% tacrolimus ointment was safe and effective for use in anterior segment inflammatory disease refractory to steroid.

Keyword

Allergic conjunctivitis; Graft vs host disease; Tacrolimus

MeSH Terms

Administration, Topical
Adolescent
Adult
Child
Conjunctivitis, Allergic/*drug therapy
Female
*Graft vs Host Disease
Humans
Immunosuppressive Agents/*administration & dosage
Male
Middle Aged
Ointments
Prospective Studies
Statistics, Nonparametric
Tacrolimus/*administration & dosage
Treatment Outcome

Figure

• 

  Fig. 1 The conjunctival inflammatory score change. The degree of inflammation reduction by section was assessed at weeks one, two, four, and eight after beginning the tacrolimus ointment treatment. The mean conjunctival inflammation score was reduced significantly (p < 0.0001), from 2.46 ± 0.79 to 0.75 ± 0.40 at eight weeks after treatment. Meaningful reductions of inflammation initially appeared at week 2 (p = 0.002). Pre = pretreatment; Post = posttreatment.

• 

  Fig. 2 The corneal inflammatory score change. The degree of inflammation reduction by section was assessed at weeks one, two, four, and eight after the beginning of tacrolimus ointment treatment. The mean conjunctival inflammation score was reduced significantly (p < 0.0001), from 2.75 ± 1.00 to 0.80 ± 0.61 at eight weeks after treatment. Meaningful reductions in inflammation were initially observed at week 1 (p = 0.0009). Pre = pretreatment; Post = posttreatment.

• 

  Fig. 3 Palpebral conjunctival photo of a 14-year-old vernal keratoconjunctivitis patient. (A) Before treatment. Injected, engorged, and active giant papillae were noted. (B) After eight weeks of treatment, the active lesions look improved. (C) After six months of treatment. Giant papillae are flat and pale. The morphology of the papillae has changed, becoming reminiscent of a fibrotic scar.

• 

  Fig. 4 Corneal photo of 33-year-old graft versus host disease patient. (A) Prior to treatment, a large-sized corneal epithelial defect was noted. (B) After eight weeks of treatment, corneal lesions were more obviously improved.

• 

  Fig. 5 The conjunctival inflammatory score change according to the diagnosis. No differences were noted to exist between vernal keratoconjunctivitis (VKC) and graft versus host disease (GVHD) at each time point (p > 0.05). Pre = pretreatment; Post = posttreatment.

• 

  Fig. 6 The corneal inflammatory score change according to the diagnosis. We noted no differences between vernal keratoconjunctivitis (VKC) and graft versus host disease (GVHD) at each time point (p > 0.05). Pre = pretreatment; Post = posttreatment.

• 

  Fig. 7 The conjunctival inflammatory score change according to maintenance. At the final follow-up, no differences were noted between the maintenance group and the discontinued group (p > 0.05). Pre = pretreatment; Post = posttreatment.

• 

  Fig. 8 Corneal inflammatory score change according to maintenance. At the final follow-up, no differences were noted in the maintenance group and discontinued group (p > 0.05). Pre = pretreatment; Post = posttreatment.

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