RESEARCH - Long term efficacy and safety of Humira plus MTX in RA: ARMADA 4 year extended study

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ls of the Rheumatic Diseases

Published Online First: 24 November 2005. doi:10.1136/ard.2005.044404

© 2006 by BMJ Publishing Group Ltd & European League Against Rheumatism

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EXTENDED REPORT

Long term efficacy and safety of adalimumab plus methotrexate in patients

with rheumatoid arthritis: ARMADA 4 year extended study

M E Weinblatt1, E C Keystone2, D E Furst3, A F Kavanaugh4, E K Chartash5 and

O G Segurado6

1 Division of Rheumatology, Immunology and Allergy, Brigham and Women's

Hospital, Boston, MA, USA

2 The Mac Centre for Arthritis and Autoimmunity, Mount Sinai

Hospital, University of Toronto, Toronto, Canada

3 Rheumatology Division, Geffen School of Medicine at the University of

California-Los Angeles (UCLA), Los Angeles, CA, USA

4 Center for Innovative Therapy, University of California-San Diego,

Division of Rheumatology, Allergy and Immunology, La Jolla, CA, USA

5 Immunology, Abbott Laboratories, Parsippany, NJ, USA

6 Immunology, Abbott Laboratories, Abbott Park, IL, USA

Objective: To evaluate the efficacy and safety of adalimumab plus

methotrexate (MTX) given for up to 4 years in patients with active,

longstanding rheumatoid arthritis.

Methods: Patients responding inadequately to MTX were entered into a 24

week, controlled study (ARMADA) with adalimumab plus MTX or placebo plus

MTX, and some were enrolled in a subsequent open label extension. The

efficacy and safety of treatment were evaluated. Additional analyses were

made for those patients whose corticosteroid and/or MTX dosages were

adjusted during the extension.

Results: Of 271 patients in the original ARMADA trial, 262 received at least

one dose of adalimumab and were evaluated. At the time of analysis, 162/262

(62%) patients had remained in the study and received treatment for a mean

of 3.4 years. Withdrawals were for lack of efficacy (8%), adverse events

(12%), and other reasons (18%). In 147 patients who completed 4 years'

treatment, efficacy achieved at 6 months was maintained. At 4 years, 78%,

57%, and 31% had achieved ACR20/50/70; 43% achieved clinical remission

(DAS28 <2.6); and 22% had no physical function abnormalities (HAQ = 0).

Results were similar for 196 patients who received treatment for 2-4 years.

Efficacy was maintained in many patients when dosages were decreased

(corticosteroids (51/81 (63%) patients), MTX (92/217 (42%)), or both (25/217

(12%))). Serious adverse events were comparable during open label treatment

and the controlled phase. Serious infections occurring during open label

treatment and the blinded period were similar (2.03 v 2.30 events per 100

patient-years, respectively).

Conclusions: Adalimumab plus MTX sustained clinical response and remission

in patients with RA during 4 years. The safety profile during the first 6

months was similar to that after 4 years' follow up. Reduction of

corticosteroid and/or MTX dosages did not adversely affect long term

efficacy.

http://ard.bmjjournals.com/cgi/content/abstract/65/6/753

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