整形外科より慢性関節リウマチで、「エンブレル皮下注25mg0.5mLシリンジ」の申請。

 米国リウマチ学会の診療ガイドラインは、「新規にRAと診断された患者の多くに対して、診断から3カ月以内に抗リウマチ薬(DMARDs)を始めるべき」と書いてあるが、何からか?不明。

米国FDAでは、以下の5成分が承認されている。

# Etanercept、国内)エンブレル皮下注、適応あり 15,309円、1週1回50mg

# Infliximab、国内)レミケード点滴静注用100、適応あり100,285円、8週1回最大10mg/kg

# Adalimumab、国内)ヒュミラ皮下注40mgシリンジ0.8mL、適応あり 71,097円、2週1回最大80mg

# Certolizumab

# Golimumab

 どれがいいのか?

Systematic review: comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis.

Ann Intern Med. 2008 Jan 15;148(2):124-34. Epub 2007 Nov 19.

メモ)

・RAの症状の軽減、関節機能の向上、X線上の症状進行の予防、評価の幅が広い

・抗TNF抗体とメトトレキサートの比較(いずれも単剤)では、臨床的反応性は同程度だが、X線上のアウトカムは抗TNF抗体薬の方が良好

・短期の副作用に関しては大きな差は見られない。

BACKGROUND: The comparative effectiveness of rheumatoid arthritis therapies is uncertain.

PURPOSE: To compare the benefits and harms of disease-modifying antirheumatic drugs (DMARDs) for adults with rheumatoid arthritis.

DATA SOURCES: Records limited to the English language and studies of adults were identified by using MEDLINE, EMBASE, The Cochrane Library, and International Pharmaceutical Abstracts from 1980 to September 2007.

STUDY SELECTION: Two persons independently selected relevant head-to-head trials and prospective cohort studies with at least 100 participants and 12-week follow-up and relevant good- or fair-quality meta-analyses that compared benefits or harms of 11 drug therapies. For harms, they included retrospective cohort studies.

DATA EXTRACTION: Information on study design, interventions, outcomes, and quality were extracted according to a standard protocol.

DATA SYNTHESIS: Head-to-head trials (n = 23), mostly examining synthetic DMARDs, showed no clinically important differences in efficacy among synthetic DMARDs (limited to methotrexate, leflunomide, and sulfasalazine) or among anti-tumor necrosis factor drugs (adalimumab, etanercept, and infliximab). Monotherapy with anti-tumor necrosis factor drugs resulted in better radiographic outcomes than did methotrexate but no important differences in clinical outcomes (for example, 20%, 50%, or 70% improvement according to American College of Rheumatology response criteria). Various combinations of biological DMARDs plus methotrexate improved clinical response rates and functional outcomes more than monotherapy with either methotrexate or biological DMARDs. In patients whose monotherapy failed, combination therapy with synthetic DMARDs improved response rates. Numbers and types of short-term adverse events were similar for biological and synthetic DMARDs. The evidence was insufficient to draw conclusions about differences for rare but serious adverse events for biological DMARDs.

LIMITATION: Most studies were short-term efficacy trials conducted in selected populations with few comorbid conditions.

CONCLUSION: Limited available comparative evidence does not support one monotherapy over another for adults with rheumatoid arthritis. Although combination therapy is more effective for patients whose monotherapy fails, the evidence is insufficient to draw firm conclusions about whether one combination or treatment strategy is better than another or is the best treatment for early rheumatoid arthritis.

→ 効果はあるが、どの薬剤がいいのか?は不明。ちょっと対象もアウトカムも広すぎる論文だ。もうちょっと調べよう。

これから)麻薬の〆、オーダリングマスタの修正、村上春樹を読み切る、写真を選ぶ。

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カテゴリー: EBM

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