[Therapy of refractory chronic polyarthritis with tumor necrosis factor alpha receptor fusion proteins (TNFR55-IgG1)--results of double-blind placebo-controlled studies over 3 months].
AIM OF STUDIES: To determine the optimal dose regimen for i.v. TNFR55-IgG1 in refractory rheumatoid arthritis.


METHODS
218 patients with refractory rheumatoid arthritis were enrolled for two double-blind placebo-controlled multicenter trials (Europe and USA). They were treated with monthly i.v. placebo, 0.01, 0.05, 0.1 or 0.5 mg/kg TNFR55-IgG1 after a 4 week wash-out of DMARDs. An additional German trial compared biweekly i.v. 20 mg TNFR55-IgG1 and monthly 50 mg following a loading does of 100 mg in 60 patients.


RESULTS
TNFR55-IgG1 induced a substantial improvement already apparent one day after the first infusion. A maximal, dose dependent effect was reached after two weeks. Later, efficacy declined in parallel to an increase in anti-TNFR55-IgG1 antibodies resulting in an increased drug clearance. The drug was well tolerated with predominantly mild or moderate adverse events.


CONCLUSIONS
Intravenous TNFR55-IgG1 was well tolerated and effective in refractory rheumatoid arthritis but the treatment schedules tested could not stabilise the initial improvement.
van de Putte
L B
LB
University Hospital Nijmegen, Department of Rheumatology, Niederlande.
Sander
O
O
Rau
R
R
D000328:Adult; D000368:Aged; D015703:Antigens, CD / Q000737:chemistry* / Q000502:physiology; D001172:Arthritis, Rheumatoid / Q000276:immunology / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000737:chemistry* / Q000502:physiology; D047888:Receptors, Tumor Necrosis Factor, Type I; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D016896:Treatment Outcome
D015703:Antigens, CD; D018124:Receptors, Tumor Necrosis Factor; D047888:Receptors, Tumor Necrosis Factor, Type I; D011993:Recombinant Fusion Proteins
Therapie der refraktren chronischen Polyarthritis mit Tumornekrosefaktor alpha Razeptor-Fusionsproteinen (TNFR55-IgG1)--Ergebnisse aus doppelblinden placebokontrollierten Studien über 3 Monate.