ORENCIA®

Efficacy 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.


ORENCIA® (abatacept) and adalimumab have a comparable onset of action and sustained response over 2 years. (1)

ACR 20 responses for both groups were comparable at 4 weeks and remained comparable through 2 years. ACR 50, 70 and 90 response rates were also comparable through 2 years.

ACR 20, 50, 70 and 90 response rates with ORENCIA® (abatacept)
and adalimumab over 2 years

Orencia AMPLE ACR 24 months

Adapted from Schiff et al. 2014
ITT population; non-responder imputation. Error bars represent 95% CI

DAS28 (CRP) with ORENCIA® (abatacept) and adalimumab over 2 years

ORENCIA DAS28 (CRP) 24 months

Adapted from Schiff et al. 2014
ITT population; LOCF imputation; adjustment based on ANCOVA model with treatment as factor and baseline values, DAS 28 stratifications as covariates

• At year 1, remission was achieved by 43.3% of patients in the ORENCIA® + MTX group
• At year 2, patients in remission had increased to 50.6% in the ORENCIA® + MTX group
Remission equals a DAS28(CRP) less than 2.6

Reference:
1. Schiff M et al. Ann Rheum Dis. 2014;73:86-94.
Primary endpoint - Non-inferiority (NI) between ORENCIA® (abatacept) and adalimumab, demonstrated by ACR 20 response at 1 year with an estimated difference of 1,8% (95% CI -5.6, 9.2).


ORENCIA® (abatacept) and adalimumab have a comparable effect on reducing radiographic progression of RA over 2 years (1)

Radiographic progression is an important outcome in RA trials; progression of joint damage correlates over the long term with disease activity and disability. (2-4) The AMPLE study shows that through 2 years both ORENCIA® (abatacept) and adalimumab were similar effective at inhibiting radiographic progression.

Percentage of radiographic non-progression with ORENCIA® (abatacept)
and adalimumab at 2 years

ORENCIA AMPLE reduces progression

Adapted from Schiff et al. 2014
ITT population; linear extrapolation if missing annual radiographic assessment.
* At year 2, the non-progression rate (change from baseline TSS ≤SDC=2.2) was 84.8% (95% CI 80.4% to 89.2%) versus 83.8% (95% CI 79.4% to 88.3%) in the abatacept and adalimumab groups, respectively. The non-progressor rate using a cut-off of ≤0.5 was 70.8% and 73.1%, respectively.


The cumulative probability plot with the distribution of change in total score from baseline to year 2 shows that inhibition of radiographic damage was similar in both treatment groups and included most patients.

Cumulative probability plot of mean change from baseline to 2 years in the van der Heijde-modified Sharp score with ORENCIA® (abatacept) and adalimumab

ORENCIA AMPLE reduces progression 24 months

Adapted from Schiff et al. 2014
ITT population; linear extrapolation if missing annual radiographic assessment.

References:
1) Schiff M et al. Ann Rheum Dis. 2014;73:86-94.
2) Bruynesteyn K et al. Ann Rheum Dis 2005;64:179–82.
3) Aletaha D et al. Arthritis Rheum 2009;60:1242–9.
4) Welsing PM et al. Arthritis Rheum 2004;50:2082–93.

 

 

427SE16PR13452

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