Safety and Efficacy of the Selective Costimulation Modulator Abatacept in Patients with Rheumatoid Arthritis Receiving Background Methotrexate: A 5-year Extended Phase IIB Study

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Figure 1
Patient disposition during the open-label longterm extension period.
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Figure 2
A. The proportion of patients originally randomized to the 10 mg/kg abatacept group who achieved ACR20, ACR50, and ACR70 responses over time. B. The proportion of patients originally randomized to the 10 mg/kg abatacept group experiencing Low Disease Activity State (DAS28 CRP ≤ 3.2) and DAS28-defined remission (DAS28 CRP < 2.6) by visit day. Responses are based on the intent-to-treat population for patients with data available at the visit of interest (as-observed analysis). Broken line represents the double-blind period; data are presented with 95% confidence intervals.

Table 1.

Safety summary during the double-blind and cumulative study periods. Data are event/100 patient-years (95% CI) unless otherwise specified.

	Double-blind Study Periods^* Abatacept 10 and 2 mg/kg Groups, 1 year	Cumulative Study Period^† All Treatment Groups Combined, 5 years
Deaths, n (%)	1 (0.5)	5 (1.7)
Discontinuations due to AE, n (%)	18 (8.2)	49 (17.1)
Discontinuations due to SAE, n (%)	9 (4.1)	32 (11.1)
AE events/100 pt-yrs	489.7 (425.46, 561.03)	374.9 (332.48, 421.20)
SAE events/100 pt-yrs	20.0 (14.03, 27.74)	18.9 (15.78, 22.37)
Infections/100 pt-yrs	94.2 (78.06, 112.58)	77.3 (67.58, 87.94)
Serious infections/100 pt-yrs	2.1 (0.57, 5.38)	3.0 (1.97, 4.35)
Malignancies/100 pt-yrs	2.1 (0.57, 5.38)	1.5 (1.07, 2.93)

↵* All patients who received at least 1 dose of study medication during the double-blind period.
↵† All patients who were randomized to abatacept (10 and 2 mg/kg) and received 1 dose of study medication, plus all patients who were randomized to placebo and entered the open-label longterm extension period (and subsequently received 1 dose of study medication. AE: adverse event, SAE: serious adverse event.