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Titolo:
DOSE-RANGE AND DOSE-FREQUENCY STUDY OF RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN PATIENTS WITH RHEUMATOID-ARTHRITIS
Autore:
CAMPION GV; LEBSACK ME; LOOKABAUGH J; GORDON G; CATALANO M; BORENSTEIN D; CALDWELL J; COHEN SA; COHEN SB; FLEISCHMANN R; HELLER MD; HOWARD P; JAFFER AM; KAINE JL; KITSIS E; KOPP EJ; MORELAND LW; OHANLAN M; PRUPAS M; ROSENBERG A; RUTSTEIN J; SACK MR; SCHIFF MH; SINGLETON CM; TABORN J; TINDALL E; WEAVER AL; YOCUM D;
Indirizzi:
AMGEN BOULDER INC,3200 WALNUT ST BOULDER CO 80301 SYNERGEN INC BOULDER CO 80301 GEORGE WASHINGTON UNIV,MED CTR WASHINGTON DC 20037 HALIFAX CLIN RES CTR DAYTONA BEACH FL 00000 CLIN RES CONSULTANTS TRUMBULL CT 00000 METROPLEX CLIN RES CTR DALLAS TX 00000 ARTHRITIS ASSOCIATES INC PEABODY MA 00000 ALLERGY & RHEUMATOL MED CLIN LA JOLLA CA 00000 SARASOTA ARTHRITIS CTR SARASOTA FL 00000 HOSP JOINT DIS & MED CTR NEW YORK NY 00000 N CAROLINA ARTHRITIS & ALLERGY CARE CTR RALEIGH NC 00000 UNIV ALABAMA BIRMINGHAM AL 00000 DESERT RES CTR LAS VEGAS NV 00000 COLORADO ARTHRITIS ASSOCIATES DENVER CO 00000 ARTHRITIS DIAGNOST & TREATMENT CTR SAN ANTONIO TX 00000 CLIN RES CTR AUSTIN TX 00000 DENVER ARTHRITIS CLIN DENVER CO 00000 ARTHRITIS CTR S TEXAS SAN ANTONIO TX 00000 MIDWEST ARTHRITIS CTR KALAMAZOO MI 00000 PORTLAND MED ASSOCIATES PORTLAND OR 00000 ARTHRITIS CTR NEBRASKA LINCOLN NE 00000 UNIV ARIZONA,HLTH SCI CTR TUCSON AZ 00000
Titolo Testata:
Arthritis and rheumatism
fascicolo: 7, volume: 39, anno: 1996,
pagine: 1092 - 1101
SICI:
0004-3591(1996)39:7<1092:DADSOR>2.0.ZU;2-Q
Fonte:
ISI
Lingua:
ENG
Soggetto:
NECROSIS-FACTOR-ALPHA; COLLAGEN-INDUCED ARTHRITIS; SYNOVIAL-FLUID; EXPRESSION; IL-1;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
26
Recensione:
Indirizzi per estratti:
Citazione:
G.V. Campion et al., "DOSE-RANGE AND DOSE-FREQUENCY STUDY OF RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN PATIENTS WITH RHEUMATOID-ARTHRITIS", Arthritis and rheumatism, 39(7), 1996, pp. 1092-1101

Abstract

Objective. To preliminarily evaluate the safety and efficacy of different dose levels and dosing frequencies of recombinant human interleukin-1 receptor antagonist (rHuIL-1Ra) in the treatment of patients withrheumatoid arthritis (RA). Methods. One hundred seventy-five patientswith active RA were enrolled in a randomized, double-blind trial of rHuIL-1Ra administered by subcutaneous injection. There were 9 treatment groups in the trial. During the initial 3-week treatment phase, patients were treated with 20, 70, or 200 mg rHuIL-1Ra, administered either once, 3 times, or 7 times per week followed by a 4-week maintenance phase, during which all patients received the treatment-phase dose once per week. To maintain the blindness of the study, patients received daily injections of either rHuIL-1Ra or placebo on the days rHuIL-1Ra was not administered. Results. Recombinant HuIL-1Ra was well tolerated. The most frequent adverse event was injection-site reactions, which were reported in 62% of patients and caused 8 patients (5%) to withdraw prematurely from the study. Five patients (3%) developed serious adverse reactions unrelated to dose or dosing frequency. Due to the lack of a placebo arm and to the multiple small treatment groups, a definitive statement regarding efficacy could not be made. However, by the end of the 3-week treatment phase, daily dosing appeared more effective than weekly dosing when assessed by the number of swollen joints, the investigator and patient assessments of disease activity, pain score, and C-reactive protein levels. Conclusion. These preliminary data suggest that rHuIL-1Ra may be safely administered by subcutaneous injection to RA patients. The frequency of dosing appears to be important in determining clinical response, with daily administration providing the most benefit. A placebo-controlled trial is in progress to further assess the clinical usefulness and to better define appropriate doses of rHuIL-1Ra in patients with RA.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 03/07/20 alle ore 16:16:18