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Evaluation of adjuvant role of topical cyclosporine 1% in acute Stevens-Johnson syndrome: a randomised control trial
  1. Namrata Sharma1,
  2. Renu Venugopal1,
  3. Ritu Nagpal1,
  4. Priyadarshini K1,
  5. Kamna Verma1,
  6. Kaushal K Verma2,
  7. NR Biswas3,
  8. Thirumurthy Velpandian4,
  9. Seema Sen5,
  10. SN Dwivedi6,
  11. Radhika Tandon1,
  12. Jeewan S Titiyal1,
  13. Rasik Vajpayee7
  1. 1Rajendra Prasad Centre for Ophthalmic Science, All India Institute of Medical Sciences, New Delhi, India
  2. 2Department of Dermatology, All India institute of Medical Sciences, New Delhi, Delhi, India
  3. 3All India Institute of Medical Sciences, New Delhi, India
  4. 4Ocular Pharmacology, All India Institute of Medical Sciences, New Delhi, India
  5. 5Ocular Pathology, All India Institute of Medical Sciences, New Delhi, India
  6. 6Department of Biostatistics, All India institute of Medical Sciences, New Delhi, Delhi, India
  7. 7University of Melbourne, The Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
  1. Correspondence to Dr Namrata Sharma, Ophthalmology, All India Institute of Medical Sciences, New Delhi, Delhi, India; namrata.sharma{at}gmail.com

Abstract

Purpose To evaluate the role of topical cyclosporine A 1% (CsA) as an adjuvant therapy in patients with acute Stevens-Johnson syndrome (SJS).

Methods This is a randomised controlled trial in which 44 patients (88 eyes) with acute SJS, presenting within 3 months from the onset of the disease, were enrolled and randomised. Group A (n=44 eyes) patients received treatment with topical CsA 1% along with standard therapy consisting of topical corticosteroids, antibiotics and lubricants. Group B (n=44 eyes) patients received topical saline drops in combination with standard therapy. Various ocular surface parameters were assessed at baseline and the 6-month follow-up.

Results The mean age of patients (years) was 23.9±15.1 in the CsA group and 26.0±18.7 in the control group (p=0.6840). The mean time from disease onset to presentation (days) was 17.0±14.0 and 12.9±11.3 in CsA and control groups, respectively (p=0.1568). At presentation, the mean grades of severity scores of various parameters were comparable. At 6 months, both groups showed a significant improvement in the mean severity grades of conjunctival hyperaemia (A, p=0.001; B, p=0.0001), mucocutaneous junction involvement (A, p=0.001; B, p=0.0001) and meibomian gland involvement (A, p=0.0471; B, p=0.006). Compared with baseline, the grades of corneal keratinisation (baseline, 0.48±0.7; 6 months, 1.02±0.8; p=0.0015) and neovascularisation (baseline, 1.07±1.2; 6 months, 1.57±1.0; p=0.0412) worsened after 6 months of CsA therapy. Intergroup comparison of grades of various parameters however did not reveal any significant difference at 6 months.

Conclusions Adjuvant treatment with topical CsA is not superior to standard therapy, in cases of acute SJS.

  • Drugs
  • Ocular surface

Data availability statement

Data are available upon reasonable request. Data are available upon request.

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Data availability statement

Data are available upon reasonable request. Data are available upon request.

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Footnotes

  • X @rasikv

  • Contributors Guarantor: NS. Overall responsibility: NS. Study supervision: NS, RV, JST, SND. Conception and design: NS, RV, RV. Data collection: NS, RV, RN, PK, KV, KKV, NRB, TV, SS, SND, RT, JST, RV. Analysis and interpretation: NS, RV, RN, PK, SND, RV. Manuscript draft and review: NS, RV, RN, PK, SS, SND, RV. Administrative, technical or material support: NS, JST, RV, RT, SS, RV.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.