Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis.
BACKGROUND
A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.


METHODS
A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n = 142) or received a placebo (n = 143). The endpoint was a flare, defined as recurrence of synovitis.


RESULTS
At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p = 0.002). The risk of a flare was 2.0 times higher for patients receiving placebo than for those continuing the second-line drug (95% CI 1.27 to 3.17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.


CONCLUSIONS
Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.
ten Wolde
S
S
Department of Rheumatology, University Hospital Leiden, Netherlands.
Breedveld
F C
FC
Hermans
J
J
Vandenbroucke
J P
JP
van de Laar
M A
MA
Markusse
H M
HM
Janssen
M
M
van den Brink
H R
HR
Dijkmans
B A
BA
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012307:Risk Factors; D012720:Severity of Illness Index; D013375:Substance Withdrawal Syndrome / Q000453:epidemiology / Q000209:etiology; D013585:Synovitis / Q000139:chemically induced / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents