Tocilizumab: therapy and safety management.
OBJECTIVE
To develop fact sheets about tocilizumab, in order to assist physicians in the management of patients with inflammatory joint disease.


METHODS
1. selection by a committee of rheumatology experts of the main topics of interest for which fact sheets were desirable; 2. identification and review of publications relevant to each topic; 3. development of fact sheets based on three levels of evidence: evidence-based medicine, official recommendations, and expert opinion. The 20 experts were rheumatologists and invited specialists in other fields, and they had extensive experience with the management of RA. They were members of the CRI (Club Rhumatismes et Inflammation), a section of the Société Francaise de Rhumatologie. Each fact sheet was revised by several. experts and the overall process was coordinated by three experts.


RESULTS
Several topics of major interest were selected: contraindications of tocilizumab; the management of adverse effects and concomitant diseases that may develop during tocilizumab therapy; and the management of everyday situations such as pregnancy, surgery, and immunizations. After a review of the literature and discussions among experts, a consensus was developed about the content of the fact sheets presented here. These fact sheets focus on several points: Several topics of major interest were selected: contraindications of tocilizumab; the management of adverse effects and concomitant diseases that may develop during tocilizumab therapy; and the management of everyday situations such as pregnancy, surgery, and immunizations. After a review of the literature and discussions among experts, a consensus was developed about the content of the fact sheets presented here. These fact sheets focus on several points: 1. in RA, initiation and monitoring of tocilizumab therapy, management of patients with specific past histories, and specific clinical situations such as pregnancy; 2. diseases other than RA, such as juvenile idiopathic arthritis; 3. models of letters for informing the rheumatologist and general practitioner; 4. and patient information.


CONCLUSIONS
These tocilizumab fact sheets built on evidence-based medicine and expert opinion will serve as a practical tool for assisting physicians who manage patients on tocilizumab therapy. They will be available continuously at www.cri-net.com and updated at appropriate intervals.
Pham
Thao
T
Service de Rhumatologie, CHU Conception, Marseille, France. thao.pham@mail.ap-hm.fr
Claudepierre
Pascal
P
Constantin
Arnaud
A
de Bandt
Michel
M
Fautrel
Bruno
B
Gossec
Laure
L
Gottenberg
Jacques-Eric
JE
Goupille
Philippe
P
Guillaume
Séverine
S
Hachulla
Eric
E
Masson
Charles
C
Morel
Jacques
J
Puéchal
Xavier
X
Saraux
Alain
A
Schaeverbeke
Thierry
T
Wendling
Daniel
D
Bruckert
Eric
E
Pol
Stanislas
S
Mariette
Xavier
X
Sibilia
Jean
J
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D000075202:Contraindications; D019317:Evidence-Based Medicine; D006801:Humans; D010353:Patient Education as Topic; D012307:Risk Factors; D017751:Safety Management
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C502936:tocilizumab