A double-blind, placebo-controlled study of anti-CD5 immunoconjugate in patients with rheumatoid arthritis. The Xoma RA Investigator Group.
OBJECTIVE
To evaluate the efficacy of an anti-CD5 ricin-linked immunoconjugate (CD5-IC) in patients with rheumatoid arthritis (RA).


METHODS
A total of 104 evaluable patients were enrolled in a multicenter, double-blind, multiple-dose, placebo-controlled study of CD5-IC.


RESULTS
Treatment with CD5-IC in doses up to 8 mg/m2/day for 4 days in 1 month failed to produce marked or prolonged T cell depletion and was no more effective than placebo in ameliorating disease manifestations. An unexpectedly high placebo response was observed in 48% of the patients. Adverse events were correlated with the dose of CD5-IC, but the treatment was generally well-tolerated.


CONCLUSIONS
At the doses used in this study, CD5-IC was ineffective for treating RA.
Olsen
N J
NJ
Vanderbilt University, Nashville, Tennessee 37232, USA.
Brooks
R H
RH
Cush
J J
JJ
Lipsky
P E
PE
St Clair
E W
EW
Matteson
E L
EL
Gold
K N
KN
Cannon
G W
GW
Jackson
C G
CG
McCune
W J
WJ
Fox
D A
DA
Nelson
B
B
Lorenz
T
T
Strand
V
V
D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000276:immunology / Q000628:therapy*; D018956:CD5 Antigens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D018796:Immunoconjugates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008212:Lymphocyte Depletion; D008875:Middle Aged; D012276:Ricin; D013997:Time Factors; D016896:Treatment Outcome
D018956:CD5 Antigens; D018796:Immunoconjugates; D012276:Ricin