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THU0246 Subcutaneous Abatacept: Long-Term Data From the Acquire Trial
  1. R. Alten1,
  2. C. Pacheco-Tena2,
  3. A. Covarrubias3,
  4. G. Leon4,
  5. E. Mysler5,
  6. M. Keiserman6,
  7. R. Valente7,
  8. P. Nash8,
  9. J. Simon-Campos9,
  10. J. Box10,
  11. C. Legerton III11,
  12. E. Nasonov12,
  13. P. Durez13,
  14. I. Delaet14,
  15. M. Genovese15
  1. 1University Medicine, Berlin, Germany
  2. 2Universidad Autónoma de Chihuahua, Chihuahua
  3. 3Centro Medico De Las Americas, Merida, Mexico
  4. 4Instituto De Ginecologia Y Reproduccion, Lima, Peru
  5. 5Organización Médica de Investigación, Buenos Aires, Argentina
  6. 6Pontificial Catholic University School of Medicine, Porto Alegre, Brazil
  7. 7Physician Research Collaboration, Lincoln, United States
  8. 8University of Queensland, Brisbane, Australia
  9. 9Centro De Especialidades Médicas/Universidad Marista, Merida, Mexico
  10. 10Box Arthritis & Rheumatology of the Carolinas, Charlotte
  11. 11Low Country Rheumatology, Charleston, United States
  12. 12Institute of Rheumatology, Moscow, Russian Federation
  13. 13Université Catholique de Louvain, Brussels, Belgium
  14. 14Bristol-Myers Squibb, Princeton
  15. 15Stanford University, Palo Alto, United States

Abstract

Background 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

Objectives To present 32-mth safety and efficacy data from the long-term extension (LTE) of ACQUIRE, during which all patients (pts) received SC ABA.

Methods ACQUIRE was a Phase IIIb, 6-mth, double-blind (DB) study in which pts with active RA (³10 swollen and ³12 tender joint count [SJC and TJC], C-reactive protein (CRP) ≥0.8 mg/dL) refractory to MTX received IV or SC ABA, plus MTX, followed by an open-label LTE when pts received SC ABA 125 mg/wk. Not all pts had reached later time points at time of analysis, as a result of differential enrolment 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, respectively, and HAQ-DI was 1.7. 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. 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 hospitalised 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 during the LTE and DB periods, respectively. ACR responses were maintained and comparable with original SC and IV groups: at Day 169, ACR 20 response rates were 80.2% (95% CI: 77.2, 83.2) and 80.0% (77.0, 83.0) and at Day 981 were 84.8% (80.8, 88.8) and 84.7% (80.7, 88.8). DAS28 (CRP) <2.6 rates (95% CI) 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.

Conclusions Over 32 mths, SC abatacept showed consistent safety with high patient retention. ACR, HAQ-DI response and DAS28 remission rates were maintained through the LTE.

References

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

Disclosure of Interest R. Alten Grant/research support from: BMS, Merck Pharma GmbH, Wyeth Pharmaceuticals, Pfizer, Consultant for: Abbott Laboratories, Horizon Pharma, Merck Pharma GmbH, Nitec Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, Speakers bureau: Abbott Laboratories, BMS, Horizon Pharma, Merck Pharma GmbH, Novartis Pharmaceuticals Corporation, Roche, C. Pacheco-Tena: None Declared, A. Covarrubias Shareholder of: UNIDAD REUMATOLOGICA LAS AMERICAS SCP, Grant/research support from: BMS, Pfizer, Lilly ICOS, G. Leon: None Declared, E. Mysler Grant/research support from: BMS, Consultant for: BMS, Speakers bureau: BMS, M. Keiserman Grant/research support from: Abbott Laboratories, Biogen Idec, Bristol-Myers Squibb, Eli Lilly and Company, Human Genome Sciences, Inc., MSD, Pfizer Inc, Roche, UCB, Inc, Novartis, Consultant for: Abbott Laboratories, Bristol-Myers Squibb, MSD, Speakers bureau: Bristol-Myers Squibb, MSD, R. Valente Grant/research support from: Pfizer, UCB, BMS, Roche, Takeda, Lilly, P. Nash Grant/research support from: BMS, Consultant for: BMS, Speakers bureau: BMS, J. Simon-Campos: None Declared, J. Box Shareholder of: Box Arthritis and Rheumatology of the Carolinas PLLC, Consultant for: BMS, Speakers bureau: BMS, C. Legerton III Consultant for: BMS, E. Nasonov Speakers bureau: Roche; Bristol-Myers Squibb Company; Abbott Laboratories; Merck Sharp & Dohme Corp; UCB Pharma, Inc, P. Durez Speakers bureau: BMS, I. Delaet Shareholder of: BMS, Employee of: BMS, M. Genovese Consultant for: Bristol-Myers Squibb

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