Subcutaneous Abatacept: Long-Term Data From the Acquire Trial

M. C. Genovese¹, C. Pacheco-Tena², A. Covarrubias³, Gustavo Leon⁴, E. Mysler⁵, M. Keiserman⁶, R. Valente⁷, P. Nash⁸, J. A. Simon-Campos⁹, J. Box¹⁰, C. Legerton III¹¹, E. Nasonov¹², P. Durez¹³, I. Delaet¹⁴ and R. Alten¹⁵, ¹Stanford University, Palo Alto, CA, ²Universidad Autónoma de Chihuahua, Chihuahua, Mexico, ³Centro Medico De Las Americas, Merida, Mexico, ⁴Instituto De Ginecologia Y Reproduccion, Lima, Peru, ⁵Organización Médica de Investigación, Buenos Aires, Argentina, ⁶Pontificial Catholic University School of Medicine, Porto Alegre, Brazil, ⁷Arthritis Center of Nebraska, Lincoln, NE, ⁸Rheumatology Research Unit, Nambour Hospital, Sunshine Coast and Department of Medicine, University of Queensland, Queensland, Australia, ⁹Centro De Especialidades Médicas/Universidad Marista, Merida, Mexico, ¹⁰Carolina Bone and Joint, Charlotte, NC, ¹¹Low Country Rheumatology, Charleston, SC, ¹²Institute of Rheumatology, Moscow, Russia, ¹³Université Catholique de Louvain, Brussels, Belgium, ¹⁴Bristol-Myers Squibb, Princeton, NJ, ¹⁵Schlosspark-Klinik, University Medicine, Berlin, Germany

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Abatacept, clinical trials and rheumatoid arthritis (RA)

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose: The Abatacept (ABA) Comparison of Sub[QU]cutaneous (SC) versus Intravenous (IV) in Inadequate Responders to MethotrexatE (MTX) (ACQUIRE) study showed comparable efficacy and safety of SC vs IV ABA over 6 mths;¹ here, we present 32-mth data from the long-term extension (LTE), during which all patients (pts) received SC ABA. Methods: ACQUIRE was a Phase IIIb, 6-mth, double-blind (DB) study of pts with active RA (³10 swollen and ³12 tender joint count [TJC and SJC], C-reactive protein (CRP) ≥0.8 mg/dL) refractory to MTX. Pts were randomized to SC ABA (125 mg/wk) with IV ABA loading (~10 mg/kg) on Day 1 or IV ABA (~10 mg/kg every 4 weeks) for 6 mths, plus MTX. After 6 mths, pts could enter the open-label LTE to receive SC ABA 125 mg/wk. Safety and efficacy were assessed for pts treated in the LTE, with efficacy presented according to original DB treatment group (as observed). Not all pts had reached later time points at time of analysis, as a result of differential enrollment in the trial. Results: Of 1372 pts entering the LTE, 1134 (82.7%) remained on therapy at time of reporting. Mean baseline RA duration was 8 yrs, TJC and SJC were 30 and 20, and HAQ-DI was 1.7. The median (range) ABA exposure was 33 (8–44) mths. The incidence rate (IR; events/100 pt-yrs) of serious adverse events for pts treated with SC ABA in the LTE (8.76 [95% CI: 7.71–9.95]) was comparable with that for SC ABA in the DB period (9.02 [6.31–12.90]) and did not increase with increasing exposure (not shown). The IR of overall and serious infections in the LTE (44.80 [41.81–48.01] and 1.72 [1.30–2.27], respectively) did not increase vs the DB period (84.62 [74.50–96.11] and 1.48 [0.62–3.56], respectively). Bacterial, viral and hospitalized infections occurred at IRs of 27.28 (25.16–29.57), 18.25 (16.61–20.06) and 1.55 (1.16–2.07) during the LTE. The IR of malignancy did not increase in the LTE (1.19 [0.86–1.66]) vs the DB period (0.59 [0.15–2.36]). Injection-site reactions occurred in 27 (2.0%) pts in the LTE (none serious) and 19 (2.6%) pts in the DB period. Overall, 139/1365 (10.2%) and 1/153 (0.7%) pts experienced immunogenicity (ECL) during the LTE and DB periods. ACR responses were maintained from Mth 6 to 32 and were comparable for original SC and IV groups (Figure). DAS28 (CRP) <2.6 rates (95% CIs) were 24 (21–27) [n=685] and 25% (22–28) [n=667] at Day 169 and 39 (33–44) [n=288] and 35% (29–40) [n=275] at Day 981 for the original SC and IV groups, respectively. HAQ-DI responses (change from baseline ≥0.3) were 73 (95% CI: 69–76) [n=691] and 68% (65–72) [n=672] at Day 169 and 74 (69–79) [n=313] and 70% (65–75) [n=303] at Day 981 for the original SC and IV groups, respectively. Conclusion: Over 32 months, SC abatacept showed consistent safety with high patient retention (82.7%). ACR, HAQ-DI responses and DAS28 remission rates were maintained through the long-term extension.

1. Genovese MC, et al. Arthritis Rheum 2011;63(10):2854–64

Disclosure:

M. C. Genovese,

Bristol-Myers Squibb,

C. Pacheco-Tena,

BMS, Janssen, Roche and Pfizer,

A. Covarrubias,
None;

G. Leon,
None;

E. Mysler,
None;

M. Keiserman,

Bristol-Myers Squibb,

R. Valente,

BMS, Novartis, Pfizer, UBS, Centocor, Lilly, Takada, HGS,

P. Nash,

Bristol-Myers Squibb,

J. A. Simon-Campos,
None;

J. Box,

Clinical research for BMS,

Bristol-Myers Squibb,

C. Legerton III,

Bristol-Myers Squibb,

E. Nasonov,
None;

P. Durez,

BMS – Less than US$2000 ,

I. Delaet,

Bristol-Myers Squibb,

R. Alten,

ABBOTT, BMS, GSK,NOVARTIS, PFIZER, UCB,

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