RESEARCH - IV or subcutaneous Humira in combination with MTX

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Scand J Rheumatol. 2004;33(3):145-53.

Rapid alleviation of signs and symptoms of rheumatoid arthritis with

intravenous or subcutaneous administration of adalimumab in combination

with methotrexate.

Rau R, Simianer S, van Riel PL, van de Putte LB, Kruger K,

Schattenkirchner M, Allaart CF, Breedveld FC, Kempeni J, Beck K, Kupper

H.

Rheumaklinik, Ratingen, Germany. rrau@...

OBJECTIVE: This randomized, placebo-controlled, double-blind, Phase 1

study assessed the magnitude, onset, and duration of response with

intravenous (i.v.) and subcutaneous (s.c.) adalimumab (Humira, Abbott

Laboratories) combined with methotrexate (MTX) in patients with active

rheumatoid arthritis (RA) despite previous MTX therapy. METHODS:

Fifty-four patients were randomized to two injections of i.v. or s.c.

adalimumab (1 mg/kg) or placebo while continuing on MTX (mean dose, 15.7

mg/week). Dosing intervals were determined by the European League

Against Rheumatism (EULAR) response criteria, and were allowed to range

from 1 to 3 months. Efficacy was mainly assessed using the EULAR

response criteria and the American College of Rheumatology (ACR)

response criteria. RESULTS: Moderate EULAR response was achieved at

least once within 29 days after the first injection in 83% and 61% of

patients receiving i.v. and s.c. adalimumab respectively, compared with

44% for placebo [probability (p) < or = 0.05 for i.v. adalimumab versus

placebo]. A 20% improvement in disease activity according to the ACR

criteria (ACR20 response) was achieved by 72% and 67% of patients

receiving i.v. and s.c. adalimumab respectively, compared with 28% for

placebo (p < or = 0.01 and p < or = 0.05, respectively, versus placebo).

By Day 15 after the first and second injections, statistically

significant moderate EULAR and ACR20 response rates were achieved with

either i.v. or s.c. adalimumab compared with placebo (p < or = 0.05).

The mean times to second injection for i.v. adalimumab, s.c. adalimumab,

and placebo were 42.2 days (range: 27-84 days), 38.3 days (range: 26-85

days), and 28.4 days (range: 26-32 days), respectively (minimum time

allowed by the protocol between the first and second injections was 4

weeks). Adalimumab in combination with MTX was well tolerated, with no

patients being withdrawn because of adverse events.

CONCLUSION: Either i.v. or s.c. adalimumab added to MTX significantly

improved the signs and symptoms of RA compared with MTX alone.

Subcutaneously administered adalimumab appeared to provide a response

that was as great, as rapid, and as enduring as that with i.v.

adalimumab.

PMID: 15228184

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=15228184 & itool=iconabstr

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Mayo Clinic in Rochester

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s Hopkins Medicine

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