ORENCIA®

Safety data from the AMPLE study

The AMPLE study is the first head-to-head phase III study powered to compare ORENCIA® (abatacept) with adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis. The primary endpoint was at 1 year but the blinded study continued for 2 years to provide controlled, comparative assessment of long term safety, efficacy and radiographic outcomes. (1) ORENCIA® (abatacept) SC was administered without an initial intravenous (IV) loading dose. According to the label ORENCIA® SC may be initiated with or without an IV loading dose.

Reference:
1. Schiff M et al. Ann Rehum Dis. 2014;73:86-94.


The safety summary of the AMPLE-study shows a solid safety profile for ORENCIA® (1)

The 2 year safety profile of ORENCIA® (abatacept) was comparable to adalimumab, with fewer discontinuations due to serious adverse events, adverse events, or serious infections.

Safety Event (%) ORENCIA® + MTX (n=318) adalimumab + MTX (n=328)
SAEs 44 (13.8) 54 (16.5)
Related SAEs 11 (3.5) 20 (6.1)
Discontinued due to SAEs 5 (1.6)
Estimate of difference (95% CI):
16 (4.9)
-3.31 (-6.01, -0.60)
Malignancies
• Discontinuations
7 (2.2)
4 (1.3)
7 (2.1)
4 (1.2)
Serious infections
• Discontinuations
12 (3.8)
0
19 (5.8)
9 (2.7)
Autoimmune Events
• Discontinuations
12 (3.8)
1 (0.3)
6 (1.8)
1 (0.3)
AEs 295 (92.8) 300 (91.5)
Related AEs 132 (41.5) 164 (50.0)
Discontinued due to AEs 12 (3.8)
Estimate of difference (95% CI):
31 (9.5)
-5.68 (-9.47, -1.88)
Deaths 1 (0.3) 1 (0.3)

Adapted from Schiff et al. 2014
As treated population

Reference:
1) Schiff M et al. Ann Rheum Dis. 2014;73:86-94.

Fewer patients discontinued ORENCIA® (abatacept) compared to adalimumab due to serious adverse events or adverse events (1)

Discontinuations due to SAEs or AEs over 2 years

ORENCIA AMPLE AE 2 years

Adapted from Schiff et al. 2014
As treated population. Estimate of difference (95% CI) between treatments in discontinuations due to SAEs:
-3.31 (-6.01 to -0.60) and due to AEs: -5.68 (-9.47 to -1.88)

  • 17 (5.4%) patients discontinued due to SAEs or AEs in the ORENCIA® (abatacept) group
  • 47 (14.4%) patients discontinued due to SAEs or AEs in the adalimumab group
  • No serious infections led to discontinuation in patients treated with ORENCIA® (abatacept), while 9 out of the 19 in the adalimumab group led to discontinuation.
  • No cases of tuberculosis were seen in patients on ORENCIA® (abatacept), while 2 cases of tuberculosis were identified in patients on adalimumab.
  • 8 out of 10 patients in the ORENCIA® (abatacept) group remained in treatment at year 2.

Reference:
1) Schiff M et al. Ann Rheum Dis. 2014;73:86-94.


ORENCIA® (abatacept) causes significantly less injection-site reactions compared to adalimumab measured after 1 year (1)

Injection-site reactions* with ORENCIA® (abatacept) and adalimumab at 1 year

Orencia injection site reactions

Adapted from Weinblatt et al. 2013
Injection-site reactions were recorded as part of the secondary outcome assessment during the AMPLE-study.
* Injection-site reactions include haematoma, erythema, rash, pruritus and haemorrhage.

Injection-site reactions with:

  • ORENCIA®(abatacept) were mild to moderate and did not cause discontinuation. (1,2)
  • adalimumab were mild, moderate and severe, and caused some discontinuation. (1,2)

References:
1) Weinblatt ME et al. Arthritis Rheum 2013;65:28–38.
2) Schiff M et al. Ann Rheum Dis 2014;73:86–94.

The difference in injection-site reactions between ORENCIA® (abatacept) and adalimumab continued through 2 years (1)

Injection-site reactions* with ORENCIA® (abatacept) and adalimumab at 2 years

Orencia injection site reactions 2 years

Adapted from Schiff et al. 2014
Estimate of difference (95% CI) between treatments in injection-site reaction at 2 years is -6.3% (-10.2, -2.3).
* Injection-site reactions include haematoma, erythema, rash, pruritus and haemorrhage

Reference:
1) Schiff M et al. Ann Rheum Dis 2014;73:86–94.

 

 

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Senast uppdaterad:  2016-11-30Ansvarig:  Marie Stenqvist