Outcome and safety of TNF
antagonist therapy in 475 consecutive outpatients (with rheumatoid arthritis or spondyloarthropathies) treated by a single physician according to their eligibility for clinical trials
- 07/12/10
, Stéphanie Benoist-Gérard, Benoît le Goff, Florence Muller-Chevalet, Yves Maugars
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Abstract |
Objective |
To investigate the effectiveness and safety of TNF⍺ antagonists in patients with rheumatoid arthritis (RA) or spondyloarthropathies (SpA) treated by a single physician, according to the presence of the inclusion and non-inclusion criteria used to select patients for pivotal clinical trials.
Methods |
Effectiveness was evaluated based on four categories defined by the DAS28-ESR and BASDAI values, from a very good response (mean DAS-28-ESR less than 3.2 and mean BASDAI less than 2.0) to failure (DAS28-ESR unchanged or greater than 5.1 and BASDAI unchanged). Serious adverse events were defined as events that required permanent TNF⍺ antagonist discontinuation or that led to sequelae, hospital admission, or death.
Results |
The study included 475 patients, 230 with RA, 226 with SpA, 10 with juvenile-onset arthritis, and nine with unclassifiable arthritis. Mean number of TNF⍺ antagonists used per patient was 1.3 and mean duration of TNF⍺ antagonist treatment was 28±23 months. Overall, 41% of patients met the inclusion and non-inclusion criteria used in pivotal trials; the proportion was 43% in the RA group and 40% in the SpA group. These patients had a 3-fold higher rate of very good responses (54 versus 19%) and a 5-fold lower rate of failures (5 versus 25%) compared to the other patients. Of the 15 (3%) patients who died, none met pivotal trial criteria. The group that met pivotal trial criteria had a significantly lower rate of serious adverse events (11 versus 16%; Chi2, p=0.0001), although age was similar in the two groups (53±16 years versus 57±14 years).
Conclusion |
Patients meeting the selection criteria used in pivotal trials had a higher response rate and significantly fewer serious adverse events.
Le texte complet de cet article est disponible en PDF.Keywords : Rheumatoid arthritis, Ankylosing spondylitis, Spondyloarthropathies, TNF⍺ antagonists, Infliximab, Etanercept, Adalimumab, Eligibility, Trials, Recommendations, Daily practice, Real life, Effectiveness, Outcome, Toxicity, Side effects, Death
Plan
Vol 77 - N° 6
P. 564-569 - décembre 2010 Retour au numéro
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