Abatacept therapy and safety management.
OBJECTIVE
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.


CONCLUSIONS
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.
Pham
Thao
T
Service de Rhumatologie, CHU Conception, Marseille, France. thao.pham@mail.ap-hm.fr
Claudepierre
Pascal
P
Constantin
Arnaud
A
Fautrel
Bruno
B
Gossec
Laure
L
Gottenberg
Jacques-Eric
JE
Goupille
Philippe
P
Hachulla
Eric
E
Masson
Charles
C
Morel
Jacques
J
Saraux
Alain
A
Schaeverbeke
Thierry
T
Wendling
Daniel
D
Mariette
Xavier
X
Sibilia
Jean
J
D000069594:Abatacept; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D017751:Safety Management / Q000379:methods*; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069594:Abatacept