Background/Purpose: Biologics are known to entail specific risks; therefore teaching patients safety skills, appropriate behaviours in situations of risks and what decisions to take in these situations is necessary. The level of knowledge of safety competences are not well known in patients treated by biologics.The objective of the study was to describe the safety competences of patients treated by biologics for inflammatory arthritis and to determine the factors associated with a lower level of competences.

Methods: Data were obtained from a national cross-sectional survey. To be as representative as possible of the patients treated by biologics, rheumatologists were randomly sampled from the national directory. They were invited to include 3 to 5 consecutive patients treated by biologics whatever their inflammatory arthritis diagnosis.All patients completed a 55-item questionnaire (BioSecure*) assessing patients’ self-care safety skills and sociodemographic characteristics, type of information received, quality of life and coping style data. Rheumatologists completed personal and practice data.The questionnaire measuring knowledge and skills regarding biologics was developed by health professional and patients using 3 steps: elaboration of an exhaustive list of competences, selection via a Delphi technique then elaboration of a questionnaire for the 26 competences selected. The questionnaire includes a series of multiple-choice questions on knowledge and on clinical situations grouped in dimensions.

Results: Of the 671 patients included, 67% were women, 62% had RA and 38% spondylarthritis, 63% were treated by subcutaneous antiTNF. The mean age was 53±13 years old. Patients received information during a medical consultation (90%), a consultation with a nurse (30%), with a written booklet (59%) and during a therapeutic education program (11%). The median total score (percentage of right items) was 73 (interquartile 60-82). Knowledge items had not higher percentages of correct answers than behavioural skills items. Scores and number (%) of patients with a number of correct answers lower than 50% are described in the table. In multivariate analysis, several patients’ factors were associated with a lower level of competences: living alone, a lower education level, living in a big city, not to be employed and having not received written information or therapeutic education. Rheumatologists treating more than 80 patients with biologists had an increased risk of having their patients in the moderate skills group compared to the high skills group.

		N° items				Patients with a  n° of wright items < 50%
			Median	Q1	Q3	N	%
Biologics management		11	100.0	90.9	100.0	12	(1.8)
	General knowledge	4	100.0	75	100.0	24	(3.6)
	Communication	4	100.0	100	100	17	(2.5)
When to consult		15	73.3	53.3	86.7	145	(21.4)
	Fever	11	81.8	54.5	90.9	127	(18.8)
	Infectious symptoms	4	75.0	25	100	188	(27.8)
Specific situations		19	73.7	52.6	84.2	128	(18.9)
	Vaccination. Injuries	8	62.5	50	87.5	167	(24.7)
	Dental care	2	100.0	50	100	79	(11.7)
	Surgery	7	85.7	57.1	100	86	(12.7)
	Planning child conception	2	50.0	0	100	336	(49.6)
Sub-cutaneous injection		3	66.7	66.7	66.7	245	(36.2)

Conclusion: Safety competences can be improved, especially competences needed to deal with infectious symptoms, vaccinations, planned surgery and planning child conception. These results provide also elements to help identifying patients who need therapeutic education or to adapt the messages given.

*L Gossec. Ann Rheum Dis 2010;69(Suppl3):476

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