GUIDELINES - Orencia therapy and safety management

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Joint Bone Spine. 2009 May;76 Suppl 1:S3-S55.

Abatacept therapy and safety management.

Pham T, Claudepierre P, Constantin A, Fautrel B, Gossec L, Gottenberg

JE, Goupille P, Hachulla E, Masson C, Morel J, Saraux A, Schaeverbeke

T, Wendling D, Mariette X, Sibilia J.

Service de Rhumatologie, CHU Conception, Marseille, France.

OBJECTIVES: To elaborate a how-to-use abatacept material intended to

help physicians in the management of patients with inflammatory

diseases treated with this drug in routine practice.

METHODS: 1) Selection of the relevant domains by a rheumatologists'

panel; 2) Search for published evidence in each domain; 3) Elaboration

of the clinical tool guide with a 3-level gradation of evidence

(evidence-based medicine EBM, official recommendations and expert's

opinion). The experts were 11 academic rheumatologists with a large

experience in prescribing abatacept and in managing rheumatoid

arthritis. They were all members of the CRI (Club Rhumatismes et

Inflammation), a section of the French Rheumatology Society dedicated

to the inflammatory rheumatic diseases. Each fact sheet was reviewed

by two other experts; 4) Regular updating based on medical literature

and postmarketing surveillance data.

RESULTS: Four domains were considered relevant: abatacept

contraindications, management of side effects or associated diseases

appearing during abatacept treatment, management of " practical

situations " such as surgery or pregnancy, physician and patient

information. After the literature analysis and discussion during an

experts' meeting, a consensus was reached on: a pre-treatment

checklist aimed at searching abatacept contraindications; a what-to-do

document when facing side effects or associated diseases (autoimmune

pathology, bacterial or viral infections, cardiovascular diseases,

intolerance to abatacept, solid or haematological malignancy) or

" practical situations " (surgery, pregnancy, vaccination, travel,

drug-drug interactions); an example of standard information letter to

be addressed to the attending physician (rheumatologist and general

practitioner); an example of standard information letter to be

addressed to the patient.

CONCLUSION: Based on both an EBM approach and an expert's opinion

approach, this abatacept clinical tool guide should provide assistance

to all physicians attending patients treated with abatacept. For a

better implementation in clinical practice, this tool guide will be

available online at www.cri-net.com and regularly updated.

PMID: 19560051

http://www.ncbi.nlm.nih.gov/pubmed/19560051

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