Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Subcutaneous (SC) Abatacept (ABA) Versus Intravenous (IV) ABA in Patients (pts) with Rheumatoid Arthritis: Long-Term Data From the ACQUIRE (Abatacept Comparison of SubQUcutaneous versus Intravenous in Inadequate Responders to MethotrexatE) Trial.
Genovese1, Mark C., Cobos2, Arturo Covarrubias, Leon3, Gustavo, Mysler4, Eduardo F., Keiserman5, Mauro W., Valente6, Robert M., Nash7, Peter T.
Stanford Univ Medical Center, Palo Alto, CA
Box Arthritis & Rheumatology of the Carolinas, Charlotte, NC
LowCountry Rheumatology, Charleston, SC
Institue of Rheumatology, Moscow
Université Catholique de Louvain, Brussels, Belgium
Bristol-Myers Squibb, Princeton, NJ
Schlosspark-Klinik, Berlin, Germany
Calle Maiz No 49, Mexico, Mexico
Instituto De Ginecologia Y Reproduccion, Lima, Peru
OMI, Buenos Aires, Argentina
Pontiphycial Catholic Univ, Porto Alegre, Brazil
Arthritis Center of Nebraska, Lincoln, NE
University of Queensland, Brisbane, Australia
Centro De Especialidades Médicas, Merida, Mexico
Poznañski O[sacute]rodek Medyczny 'Novamed', Poznañ, Poland
Efficacy and safety of IV ABA is well established in RA. The ACQUIRE trial showed comparable safety and efficacy in SC vs IV ABA over 6 mths1; here, we present 18-mth data from the long-term extension (LTE).
ACQUIRE was a Phase IIIb, 6-mth, double-blind (DB) double-dummy study of pts with active RA (>=10 swollen and >=12 tender joint count [TJC and SJC], CRP >=0.8 mg/dL) refractory to MTX. Pts were randomized to SC ABA (125 mg/week) with IV ABA loading (~10 mg/kg) on Day 1 or IV ABA (~10 mg/kg) on Days 1, 15, 29 and every 4 wks for 6 mths; all pts received MTX. After 6 mths pts could enter the open-label LTE to receive SC ABA 125 mg/week. Safety, immunogenicity (by electrochemiluminescence), and efficacy (ACR 20, 50 and 70 and HAQ-DI responses [improvement from baseline (BL) >=0.3]) were assessed for pts treated with >=1 dose of ABA in the LTE. Efficacy data are as-observed; not all pts reached later timepoints at time of analyses.
Of 1372 pts entering the LTE, 1222 (89.1%) remained on therapy at time of reporting. Overall mean BL RA duration was 8 yrs, TJC and SJC were 30 and 20, and HAQ-DI was 1.7; characteristics were similar between groups. Median (SD) ABA exposure was 22 (3.8) mths. The IR (events/100 ptyrs) of SAEs in the LTE was comparable with that seen with SC ABA in the DB period (9.00 [95% CI: 7.6910.55] and 9.02 [6.3112.90], respectively) and did not increase with increasing exposure (not shown). The IR of overall and serious infections in the LTE did not increase vs the DB period (47.64 [44.0151.58] vs 84.62 [74.5096.11] and 1.97 [1.412.74] vs 1.48 [0.623.56] respectively) and did not increase with increasing exposure (not shown). Opportunistic infections in the LTE included 3 TB cases and 2 candidiasis cases; no opportunistic infections were observed in the DB period. Injection site reactions occurred in 24 (1.7%) pts in the LTE (none serious). ABA-induced antibodies occurred in 39/1365 (2.9%) pts in the LTE; 4/11 pts with anti-CTLA4 antibodies eligible for testing were positive for neutralizing antibody. Immunogenicity did not affect efficacy, safety or ABA pharmacokinetics (data not shown). ACR responses up to Mth 24 were maintained from Mth 6 and comparable between original SC vs IV groups (Fig). DAS28 remission rates (95% CIs) were 24 (2127) [n=685] vs 25% (2228) [n=688] at Day 169 and 32 (2242) [n=85] vs 31% (2041) [n=72] at Day 729 in the original SC vs IV groups, respectively. HAQ responses (95% CIs) were 73 (6976) [n=691] and 68% (6572) [n=672] at Day 169 and 63 (5373) [n=87] and 56% (4567) [n=77] at Day 729 in the original SC and IV groups, respectively. At the time of analyses, most patients had not completed the later timepoints (Days 617, 729).
Over 24 mths, SC ABA showed acceptable safety, with high pt retention, similar to the IV experience. Efficacy was comparable between SC and IV groups; ACR and HAQ responses and DAS28 remission rates were maintained in the LTE.
To cite this abstract, please use the following information:
Genovese, Mark C., Cobos, Arturo Covarrubias, Leon, Gustavo, Mysler, Eduardo F., Keiserman, Mauro W., Valente, Robert M., et al; Subcutaneous (SC) Abatacept (ABA) Versus Intravenous (IV) ABA in Patients (pts) with Rheumatoid Arthritis: Long-Term Data From the ACQUIRE (Abatacept Comparison of SubQUcutaneous versus Intravenous in Inadequate Responders to MethotrexatE) Trial. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :402