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 with rheumatoid arthritis (RA). METHODS: One hundred seventy-five patients with 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 rHulL-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.
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Authors | G V Campion, M E Lebsack, J Lookabaugh, G Gordon, M Catalano |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 39
Issue 7
Pg. 1092-101
(Jul 1996)
ISSN: 0004-3591 [Print] United States |
PMID | 8670316
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies
- IL1RN protein, human
- Interleukin 1 Receptor Antagonist Protein
- Receptors, Interleukin-1
- Recombinant Proteins
- Sialoglycoproteins
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Topics |
- Antibodies
(blood)
- Arthritis, Rheumatoid
(complications, immunology, therapy)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Injections, Subcutaneous
- Interleukin 1 Receptor Antagonist Protein
- Male
- Middle Aged
- Quality of Life
- Receptors, Interleukin-1
(antagonists & inhibitors, immunology)
- Recombinant Proteins
(administration & dosage, adverse effects, immunology)
- Severity of Illness Index
- Sialoglycoproteins
(adverse effects, immunology, therapeutic use)
- Treatment Outcome
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