Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Adalimumab Dose Escalation Induces Durable Remissions and Is Safe in Minorities with Moderate to Severe Rheumatoid Arthritis (RA)

Karpouzas1,  George A., Broumand1,  Alexander, Bagheri1,  Shirin, Sayed1,  Leila, Louie2,  James S., Furst2,  Daniel E., Cooray1,  Dilrukshie

Harbor-UCLA Medical Center, Torrance, CA,
UCLA, Los Angeles, CA

Purpose:

Patients (pts) with RA and partial response to disease modifying drugs (DMARDs) are treated with Tumor Necrosis Factor-Alpha inhibitors (TNFi) with good results. Adalimumab (ADA) is a human monoclonal antibody that inhibits TNFa, approved for use in RA at 40mg SQ every other week (QOW) or every week (QW). We investigated whether dose escalation to QW renders additional clinical benefit, whether the responses are sustained, and if this regimen is safe.

Methods:

We studied 65 pts fulfilling 1987 criteria for RA and given ADA 40mg QOW. All had follow-up in a single academic center, where ADA is the recommended formulary drug. Subjects were largely minorities, indigent, and part of an assistance program. All had Disease Activity Scores (DAS28-3v-ESR) recorded every 3 months (mo). Good EULAR response (GER) was the primary outcome. Partial responders were given ADA 40mg QW. Flares were defined as: DAS28>3.2 and increase in DAS28>0.6 (from the initial good response) and/or addition of a new drug. Intra-articular injections and/or 1 dose of intramuscular steroid were allowed. Response and flare data was analyzed with paired t-tests and Fisher's exact tests. Adverse events were reported as n/100-PY.

Results:

Twenty two of 65 pts (33.8%) achieved GER in 5.3±3.9 mo and remained on QOW ADA for 23.5±17.8 mo. Forty three pts (66.2%) did not and received ADA 40mg QW for 17.2±12 mo. Twenty four of 43 (56%) achieved new GER within 7.5±5.9 mo, that lasted over 12±9.6 mo. Eleven of 24 (46%) had a flare within 11.7±10.2 mo, and 4/11 (36.4%) resolved without change in regimen over 4.5±3 mo. More flares occurred in the group on QW vs. on QOW ADA (OR=3.6, CI=0.9–13.9, p=0.07). GER persisted in 17/24 (71%) of the QW ADA group to the end of observation. Serious infections were 5.5/100-PY in the QW group, not different from 4.9/100-PY in the QOW group. No cases of Tuberculosis (TB) or opportunistic infections were noted.

Table 1. Patient Characteristics

 QOWQWp
n2243ns
Females (%)77.388.4ns
Age (M ± SD)51.5 ± 1052.5 ± 9.9ns
Duration8.1 ± 6.19.8 ± 7.6ns
Hispanic (%)7393ns
AA (%)57ns
RF + (%)89.597ns
a-CCP + (%)87.588ns
Erosions (%)5871ns
ESR (mm/hr)41 ± 1943 ± 24ns
% on pred31.659.5ns
% on DMARDs100100ns
n-DMARD (M ± SD)2 ± 1.12 ± 0.9ns
Time Quarters (3 mo)
DAS28QOWQW124681012
All5 ± 0.1        
QOW pt4.6 ± 0.2 3 ± 0.2*2.8 ± 0.2*2.8 ± 0.2*2.7 ± 0.3*3 ± 0.2*2.4 ± 0.4†2.1
QW pts5.2 ± 0.24.6 ± 0.1*3.6 ± 0.2*3.2 ± 0.2*3.17 ± 0.2*3 ± 0.2*2.9 ± 0.3*3.3 ± 0.3m3 ± 0.5m
SafetyQOWQW
All Infections (n/100-PY)17.120.2
Non-serious (n/100-PY)12.214.7
Serious (n/100-PY)4.955.5
    Pneumonia20
    Cellulitis/abscess23
TB00
Opportunistic00
*<0.001,†<0.01, m<0.05

Conclusion:

ADA dose escalation to 40 mg QW in partial responders induced new and durable GER. It was well tolerated with serious infections within the expected range for pts with RA.

To cite this abstract, please use the following information:
Karpouzas, George A., Broumand, Alexander, Bagheri, Shirin, Sayed, Leila, Louie, James S., Furst, Daniel E., et al; Adalimumab Dose Escalation Induces Durable Remissions and Is Safe in Minorities with Moderate to Severe Rheumatoid Arthritis (RA) [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1702
DOI: 10.1002/art.26776

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