A Consensus Conference Report on Psoriasis Therapy with Cyclosporine MEPC

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  • シクロスポリンMEPCによる乾癬治療のガイドライン2004年度版　コンセンサス会議報告
  • 生涯教育講座 シクロスポリンMEPCによる乾癬治療のガイドライン 2004年度版コンセンサス会議報告
  • ショウガイ キョウイク コウザ シクロスポリン MEPC ニ ヨル カンセンチリョウ ノ ガイドライン 2004ネンドバン コンセンサス カイギ ホウコク

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Abstract

The efficacy of cyclosporine microemulsion preconcentrate (cyclosporine MEPC) in the treatment of severe psoriasis is well-established, as demonstrated by numerous clinical trials. However, many dermatologists still continue to have some concerns regarding its use. These are mainly related to preconceptions about its side effects which include renal impairment and hypertension, and to the lack of guideline for the appropriate and effective use of cyclosporine MEPC in the treatment of severe psoriasis. A Japanese consensus conference was convened following an international conference held in Paris in order to amend The Japanese Guideline for Psoriasis Therapy with Cyclosporine MEPC. Expert reviewers presented and deliberated Japanese as well as international evidence on cyclosporine MEPC related to clinical efficacy, patient selection, and profiles of adverse drug reactions. They reached a consensus as to the proposed recommendations of the use of cyclosporine MEPC. The definition of difficult-to-treat in the context of patient selection for cyclosporine MEPC was changed from a PASI score ≧ 18 to 12, and “patients unsatisfied with the effects of their current therapy” was newly added concerning the impact of psoriasis on patients’ QOL in QOL assessments by patients. Because a dose of 2.5mg/kg/day has been reported to show adequate efficacy, a suggested range of 2.5 to 5.0mg/kg/day was set. Because, at the dose of 2.5 mg/kg/day, 70% improvement of PASI scores was achieved at 12-weeks, it was recommended that the course of subsequent therapy should be re-examined based on the efficacy checked after three months following the start of therapy. Patients’ QOL and patient assessment of efficacy were also added as efficacy outcome measures in addition to PASI score, affected body surface area, and degrees of pustules and pruritus. Serum creatinine level (S-Cr) was recommended as a measure for assessing renal impairment, and it was stated that a detailed kidney test should be performed by a renal specialist if S-Cr levels do not show any improvement about one month after withdrawal of treatment. The Guidelines will be revised in 2004 based on the consensus reached.

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