Comparative clinical utility of once-weekly subcutaneous abatacept in the management of rheumatoid arthritis

Figures & data

Table 1 Summary of Phase III trials of subcutaneous abatacept in rheumatoid arthritis

	ACQUIRE^Citation19		AMPLE^Citation23		ACCOMPANY^Citation20		ALLOW^Citation21		ATTUNE^Citation22
Entry requirements: disease activity	≥ 12 tender joints ≥ 10 swollen joints CRP ≥0.8 mg/dL		DAS28 (CRP) ≥3.2 Anti-CCP or RF Elevated ESR or CRP		Global VAS >20		DAS28 (CRP) ≥3.2 and ≤5.1		Active RA ≥4 years treatment with IV ABT
Entry requirements: previous therapy	IR to MTX		IR to MTX biologic-naïve		IR to ≥ 1 DMARD (IR to MTX or MTX-naïve)		IR to MTX		IR to anti-TNF
Study design	Phase IIIb, double-blind, double-dummy, noninferiority study		Phase IIIb, double-blind, noninferiority study		Phase III open-label study		Phase IIIb, 3 × 12-week periods: open-label SC ABT double-blind SC placebo/ABT open-label reintroduced SC ABT		Phase IIIb, open-label, single-arm study
Study duration	6 months		24 months		4 months		9 months		12 months
Primary endpoint(s)	ACR 20 at month 6		ACR 20 at month 12		Immunogenicity rate of SC ABT at month 4		Immunogenicity and safety of SC ABT at month 6		Safety through month 3 after switching from IV to SC ABT
Treatment	SC ABT + MTX	IV ABT + MTX	SC ABT + MTX	ADA + MTX	SC ABT	SC ABT + MTX	SC ABT + MTX (withdrawal/reintroduction)	SC ABT + MTX (continuous)	SC ABT in MTX IR	SC ABT in anti-TNF IR
Patients (n)	736	721	318	328	49	51	80	40	71	52
Disease duration: years (mean, SD)	7.6 (8.1)	7.7 (7.8)	1.9 (1.4)	1.7 (1.4)	All patients: 10.1 (11.1)		6.2 (5.8)	7.4 (7.7)	NR	NR
% ACR 20	76%	75.8%	64.8%	63.4%	NR		NR		NR
DAS28-CRP mean change (95% CI)	−2.57 (−2.67, −2.47)a	−2.55 (−2.65, −2.45)a	−2.30 (−2.46, −2.14)c	−2.27 (−2.43, −2.11)c	−1.94 (−2.46, −1.42)	−1.67 (−2.06, −1.28)	−2.03 (−2.4, −1.66)	−1.49 (−1.77, −1.2)	−0.37b (NR)	−0.11b (NR)
DAS28-CRP remission % (95% CI)	24.2 (20.9, 27.4)	24.8 (21.5, 28.1)	43.3 (37.3, 49.1)	41.9 (36, 47.9)	LTE month 18 58.3 (42.2, 74.4)	LTE month 18 42.5 (27.2, 57.8)	Month 9 51.3 (35.6, 67)	Month 9 63.5 (52.5, 74.5)	48.6 (NR)	24.5 (NR)
HAQ-DI change (mean, 95% CI)	−0.69 (−0.73, −0.65)a	−0.70 (−0.74, −0.66)a	−0.60 (−0.68, −0.52)a	−0.59 (−0.67, −0.51)a	−0.58 (−0.74, −0.42)	−0.31 (−0.43, −0.19)	−0.50 (−0.63, −0.37)	−0.72 (−0.95, −0.50)	−0.09 (NR)	−0.06 (NR)
Pain VAS (mean, 95% CI)	49.1%c (45.7, 52.5)c	44.9%c (41.4, 48.4)c	53%c (41.4, 65)	39.2%c (27.4, 51)	NR		NR		NR
Retention rate	94.2%	93.8%	86.2%	82%	All patients 96% at month 4, 83% up to month 18 LTE		98.8%	100%	All patients 91.1%
Radiographic progression: SHS (mean ± SD)	NR		0.58 (3.22)	0.38 (5)	NR		NR		NR

Notes:

a Maintained improvement in DAS28-CRP at month 3 after switching from IV abatacept

b adjusted improvement from baseline

c calculated 95% CI.

Abbreviations: CRP, C-reactive protein; DAS28, disease activity score in 28 joints; anti-CCP, anti-citrullinated peptide; RF, rheumatoid factor; VAS, visual analog scale; RA, rheumatoid arthritis; IV, intravenous; ABT, abatacept; IR, inadequate response; SC, subcutaneous; MTX, methotrexate; DMARDs, disease-modifying anti-rheumatic drugs; anti-TNF, anti-tumor necrosis factor; SD, standard deviation; NR, not reported; ACR 20, American College of Rheumatology 20% improvement criteria; ADA, adalimumab; LTE, long-term extension; CI, confidence interval; SHS, modified Sharp/van der Heijde score.

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