Anti-tumor necrosis factor-alpha therapy in the ordinary clinical setting: Three-year effectiveness in patients with rheumatoid arthritis.
OBJECTIVE
The aim was to estimate the proportion of patients with rheumatoid arthritis (RA) achieving low disease activity by anti-tumor necrosis factor-alpha (TNF-alpha) therapy in an ordinary clinical setting.


METHODS
Thirty-three patients with active RA despite methotrexate treatment were included in an open phase IV study of infliximab in combination with methotrexate. The mean age was 53years (range 21-71) and mean disease duration 10.7years (1-32). Treatment was changed in cases of insufficient response or intolerable adverse events. Response status to infliximab was assessed according to the American College of Rheumatology (ACR 20). Disease activity score (DAS28) was assessed at baseline and at weeks 26, 54, 80, 106 and 158. Low disease activity is defined as DAS28 <or=3.2.


RESULTS
ACR20 response to infliximab was recorded in 73% and 33% of the patients at weeks 26 and 158, respectively. Infliximab was discontinued in 16 patients, 15 of whom started other anti-TNF-alpha therapy. The baseline DAS28-score of 6.3 (95% CI 5.9-6.6) was significantly reduced after 26weeks to 4.1 (95% CI 3.6-4.7) and was later nearly stable. Low DAS28 was achieved by 36% of the patients at week 26, and by 15-24% at later assessments.


CONCLUSIONS
RA disease activity was significantly reduced, but DAS28 <or=3.2 was recorded in only 1/4 of the assessments. Increasing this proportion should be subject to continuous quality improvement efforts.
Kvalvik
Anne Grimstvedt
AG
Haugesund Rheumatism Hospital, Karmsundsgaten 134, Post office box 2175, N-5504 Haugesund, Norway. anne.grimstvedt.kvalvik@hsr.as
Lefsaker
Liv
L
Dyvik
Siri
S
Brun
Johan Gorgas
JG
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006304:Health Status; D006801:Humans; D000069285:Infliximab; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D011239:Prednisolone; D000069285:Infliximab; D008727:Methotrexate