ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1679

Cumulative Long-Term Safety and Efficacy of Abatacept in Children with Juvenile Idiopathic Arthritis: Results up to 7 Years of Follow-up

D. J. Lovell1, N. Ruperto2, R. Mouy2, E. Paz2, N. Rubio-Perez2, C. A. Silva2, C. Abud-Mendoza2, R. Burgos-Vargas2, V. Gerloni2, J. a. Melo-Gomes3, C. Saad-Magalhaes2, J. Chavez4, C. Huemer2, A. Kivitz2, F. Blanco2, I. Foeldvari2, Michael Hofer5, H. Huppertz2, C. Job Deslandre2, K. Minden2, A. Flores Nunez6, A. J. Block7 and A. Martini2, 1Cincinnati Children's Hospital, Cincinnati, OH, 2PRINTO, IRCCS G. Gaslini, Genoa, Italy, 3Pediatria II, Istituto Giannina Gaslini, Genoa, Italy, 4PRINTO, Genoa, Italy, 5Paediatric Rheumatology International Trials Organization (PRINTO), Istituto Giannina Gaslini, Genoa, Italy, 6PRINTO, IRCCS Hospital para el Niño Poblano, Puebla, Mexico, 7Bristol-Myers Squibb, Princeton, NJ

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Pediatric Rheumatology: Clinical and Therapeutic Disease II: Juvenile Idiopathic Arthritis II

Session Type: Abstract Submissions (ACR)

Background/Purpose: We previously reported the efficacy and safety of abatacept (ABA) in patients with juvenile idiopathic arthritis (JIA) in the AWAKEN trial1, during the 4-month open-label ABA lead-in phase and 6-month double-blind (DB) (ABA vs placebo [PBO]) period. Long-term efficacy and safety were also described for 153 patients who received open-label ABA in the long-term extension (LTE) for ≥21 months.2 We now report efficacy and safety data from the cumulative LTE for an additional ~30 months of exposure up to 7 years of total follow-up. Methods: Patients entered the LTE and received open-label intravenous ABA if they were a non-responder (NR) in the 4-month open-label lead-in phase, or if they either experienced a flare or completed the 6-month DB withdrawal phase while receiving ABA or PBO. Efficacy is reported up to Day 1681 of the LTE (~Year 5.5 of the study), and safety is reported up to 7 years of treatment at study completion. Results: 190 patients entered the AWAKEN trial, with 153 entering the LTE (58/60 patients from the DB ABA group, 59/62 from the DB PBO group, and 36/47 NR patients from the open-label phase). Cumulative exposure was 606.2 years. At the start of the LTE, 46/58 (79%, ABA) and 31/59 (53%, PBO) had achieved an ACR Pediatric 50 response. Mean response of those who received PBO during the DB phase recovered completely within 6 months after re-instating ABA therapy in the LTE and these results were combined with those of patients in the ABA group starting from LTE Month 6 (Figure). ACR Pediatric 50, 70 and inactive disease rates are shown. Of the open-label responders, 32/110 (29%, Day 169) to 36/79 (46%, Day 1177) had inactive disease status. Of the NR, 4/13 (31%) achieved inactive disease at the end of the trial. There was one death (accidental; unrelated). The major reason for discontinuation in the LTE was lack of efficacy in 24 patients (15.7%, 11 were NR); 6 discontinuations due to AEs (3/6 due to serious AEs); 13, loss to follow-up; 10, withdrawal of consent; and 18 “other” (not efficacy or safety). Thirty patients (19.6%) had serious AEs; most were unrelated and were primarily musculoskeletal or infectious events. Incidence rate (per 100 patient-years [pt-yrs]) of SAEs in the LTE (5.6/100 pt-yrs) did not increase versus the 6-month DB rate (6.8/100 pt-yrs). No malignancy was reported. Of the 153 patients entering the LTE, 69 patients completed the trial (29, 27 and 13 in the original ABA, PBO and NR groups, respectively). Conclusion: These data demonstrate the sustained efficacy of abatacept in JIA patients. Additional exposure of ~30 months did not change the safety profile of abatacept in these patients when compared to prior LTE experience.2   1. Ruperto N, et al. Lancet 2008;372:383–91 2. Ruperto N, et al. Arthritis Rheum 2010;62:1792–802   Figure (2).jpg

Disclosure:

D. J. Lovell,

Astra-Zeneca, Centocor, Bristol-Myers Squibb, Abbott, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, Genentech,

5,

Wyeth Pharmaceuticals,

8,

Amgen, Forest Research,

9,

Arthritis & Rheumatism,

9;

N. Ruperto,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

8;

R. Mouy,
None;

E. Paz,

Bristol-Myers Squibb,

2;

N. Rubio-Perez,
None;

C. A. Silva,
None;

C. Abud-Mendoza,
None;

R. Burgos-Vargas,

ABBOTT, BMS, JANSSEN, PFIZER, ROCHE,

5,

ABBOTT, BMS, JANSSEN, PFIZER, ROCHE,

8;

V. Gerloni,
None;

J. A. Melo-Gomes,
None;

C. Saad-Magalhaes,
None;

J. Chavez,

Roche Pharmaceuticals,

2;

C. Huemer,
None;

A. Kivitz,
None;

F. Blanco,

Roche, Bristol, Pfizer, Bioiberica, Celgene, UCB, Sanofi, MSD [Merck Sharpe & Dohme], Grunenthal, Cellerix,

2,

Bioiberica, Gebro, Pfizer,

5;

I. Foeldvari,

Actelion Pharmaceuticals US,

2,

Novartis, Abbott, Pfizer,

5;

M. Hofer,

Novartis and BMS,

5;

H. Huppertz,
None;

C. Job Deslandre,
None;

K. Minden,

Pfizer,

2,

Pfizer, Abbott, Roche, Chugai, Novartis, Medac,

5;

A. Flores Nunez,
None;

A. J. Block,

Bristol-Myers Squibb,

3,

Bristol-Myers Squibb,

5;

A. Martini,

BMS,

2,

Bristol-Myers Squibb,

8.

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