Spotlight on certolizumab pegol in the treatment of axial spondyloarthritis: efficacy, safety and place in therapy

Figures & data

Figure 1 Chart flow of RAPID-axSpA trial^27–32 during the three different phases of the trial.

Abbreviations: CZP, certolizumab pegol; axSpA, axial spondyloarthritis.

Table 1 Efficacy of subcutaneous certolizumab pegol in adult patients with axial spondyloarthritis in the randomized, double-blind, multicenter RAPID-axSpA trial²⁸

Outcome	All patients axSpA (N= 218)					AS (N = 121)					nr-axSpA (N = 97)
	Baseline	Week 24	Week 24	Week 204	Week 204	Baseline	Week 24	Week 24	Week 204	Week 204	Baseline	Week 24	Week 24	Week 204	Week 204
	N = 218	OC (N = 205)	Imputed	OC (N = 140)	Imputed	N = 121	OC (N = 112)	Imputed	OC (N = 80)	Imputed	N= 97	OC (N = 93)	Imputed	OC (N =60)	Imputed
ASDAS-ID, n/N (%)		66/205 (32.2)	66 (30.3)	44/140 (31.4)	70 (32.1)		33/112 (29.5)	33 (27.3)	23/80 (28.8)	39 (32.2)		33/93 (35.5)	33 (34)	21/60 (35)	31 (32)
ASDAS-MD, n/N (%)	3 (1.4)	51/205 (24.9)	54 (24.8)	41/140 (29.3)	59 (27.1)	2 (1.7)	27/112 (24/1)	29 (24)	25/80 (31.3)	33 (27.3)	1 (1)	24/93 (25.8)	25 (25.8)	16/60 (26.7)	26 (26.8)
ASAS20, n/N (%)		147/201 (73.1)	149 (68.3)	113/135 (83.7)	118 (54.1)		81/108 (75)	83 (68.6)	64/75 (85.3)	68 (56.2)		66/93 (71)	66 (68)	49/60 (81.7)	50 (51.5)
ASAS40, n/N (%)		111/201 (55.2)	113 (51.8)	91/135 (68.1)	96 (44)		62/108 (57.4)	64 (52.9)	51/75 (68)	54 (44.6)		49/93 (52.7)	49 (50.5)	41/60 (68.3)	42 (43.3)
ASAS 5/6, n/N (%)		90/199 (45.2)	92 (42.2)	72/134 (53.7)	75 (34.4)		48/108 (44.4)	48 (39.7)	40/75 (53.3)	41 (33.9)		42/91 (46.2)	44 (45.4)	32/59 (54.2)	34 (35.1)
ASAS-PR, n/N (%)		66/204 (32.4)	66 (30.3)	50/137 (36.5)	51 (23.4)		34/111 (30.6)	34 (28.1)	25/77 (32.5)	26 (21.5)		32/93 (34.4)	32 (33)	25/60 (41.7)	25 (25.8)
BASDAI ≤2 PCR normal, n/N (%)		66/205 (32.2)	66 (30.3)	46/142 (32.4)	72 (33)		33/112 (29.5)	33 (27.3)	23/81 (28.4)	38 (31.4)		33/93 (35.5)	33 (34)	23/61 (37.7)	34 (35.1)
BASDAI 50, n/N (%)		114/205 (55.6)	114 (52.3)	89/140 (63.6)	89 (40.8)		59/112 (52.7)	59 (48.8)	51/80 (63.8)	51 (42.1)		55/93 (59.1)	55 (56.7)	38/60 (63.3)	38 (39.2)
Mean (SD) ASDAS	3.8 (0.9)	2 (1)	2.1 (1.1)	1.9 (0.9)	2 (1.1)	3.9 (0.99)	2 (1)	2 (1.1)	2 (0.9)	2.1 (1.2)	3.8 (0.8)	2 (1.1)	2 (1.1)	1.8 (1)	1.9 (1)
Mean (SD) BASDAI	6.4 (1.5)	3.2 (2.2)	3.3 (2.3)	2.7 (2)	3 (2.3)	6.4 (1.5)	3.2 (2.1)	3.4 (2.2)	2.8 (1.9)	3 (2.3)	6.6 (1.5)	3.2 (2.5)	3.3 (2.5)	2.6 (2.2)	2.9 (2.3)
Mean (SD) BASFI	5.3 (2.3)	2.9 (2.5)	3 (2.5)	2.6 (2.2)	2.7 (2)	5.6 (2.3)	3.2 (2.6)	3.3 (2.6)	2.9 (2.2)	3 (2.4)	5 (2.3)	2.6 (1.5)	2.6 (1.5)	2.4 (1.2)	2.5 (1.3)
Mean (SD) BASMI-linear	3.8 (1.7)	3.2 (1.7)	3.2 (1.7)	3.1 (1.7)	3.1 (1.7)	4.2 (1.7)	3.6 (1.7)	3.6 (1.7)	3.6 (1.8)	3.6 (1.8)	3.2 (1.5)	2.6 (1.5)	2.6 (1.5)	2.4 (1.2)	2.5 (1.3)

Abbreviations: axSpA, axial spondyloarthritis; AS, ankylosing spondylitis; nr-axSpA, non-radiographic axial SpA; OC, observed cases; n/N, number positive/number included; ASAS, Assessment of SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASAS-PR, Assessment of SpondyloArthritis international Society Partial Remission criteria; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index.

Table 2 Effect of subcutaneous certolizumab pegol on key patient-reported outcomes in the RAPID-axSpA study³⁰

Patient-reported outcome	All patients (N = 218)					AS (N = 121)					nr-axSpA (N = 97)
	Baseline	Week 24	Week 24	Week 204	Week 204	Baseline	Week 24	Week 24	Week 204	Week 204	Baseline	Week 24	Week 24	Week 204	Week 204
	N = 218	OC (N = 205)	Imputed	OC (N = 140)	Imputed	N =121	OC (N = 112)	Imputed	OC (N = 80)	Imputed	N = 97	OC (N = 93)	Imputed	OC (N = 60)	Imputed
Morning stiffness	6.6 (1.9)	2.9 (2.4)	3 (2.5)	2.5 (2)	2.7 (2.4)	6.6 (1.9)	2.9 (2.1)	3.1 (2.2)	2.5 (1.9)	2.7 (2.3)	6.6 (1.9)	3 (2.8)	3 (2.8)	2.5 (2.2)	2.6 (2.5)
Fatigue	6.8 (1.8)	3.9 (2.6)	4.1 (2.7)	3.2 (2.2)	3.6 (2.6)	6.7 (1.9)	3.9 (2.5)	4.1 (2.6)	3.3 (2.2)	3.6 (2.6)	6.9 (1.8)	3.9 (2.7)	4 (2.7)	3.1 (2.3)	3.6 (2.6)
Sleep	49 (19.2)	35.3 (20.1)	36.2 (20.2)	32.4 (17.3)	34.4 (18.6)	46.8 (19.9)	35.1 (19.3)	36.3 (19.5)	32.3 (15.9)	34.1 (17.5)	51.7 (18)	35.4 (21.2)	36.1 (21)	32.5 (19.2)	34.9 (20)
Nocturnal back pain	6.9 (2.3)	3.1 (2.6)	3.3 (2.7)	2.7 (2.4)	3 (2.7)	6.8 (2.3)	3.1 (2.4)	3.3 (2.6)	2.7 (2.3)	3.1 (2.6)	7 (2.3)	3.1 (2.9)	3.2 (2.9)	2.7 (2.6)	2.9 (2.7)
Total back pain	7 (1.9)	3.5 (2.6)	3.8 (2.7)	3 (2.4)	3.3 (2.7)	7 (2)	3.5 (2.3)	3.8 (2.5)	3.1 (2.3)	3.4 (2.7)	7 (1.8)	3.6 (2.9)	3.8 (3)	2.8 (2.5)	3.3 (2.7)
ASQoL	11.6 (4.4)	6.2 (5.5)	6.5 (5.6)	4.9 (5)	5.7 (5.4)	11.6 (4.4)	6.3 (5.3)	6.8 (5.6)	5.2 (4.9)	5.9 (5.5)	11.6 (4.4)	6.1 (5.7)	6.1 (5.7)	4.5 (5.1)	5.3 (5.3)
SF-36 PCS	32.4 (7.5)	42.1 (10)	41.8 (9.9)	44.3 (9.4)	43.5 (9.6)	31.7 (7.2)	41.3 (9.6)	40.7 (9.6)	43.7 (9.5)	42.8 (10)	33.2 (7.9)	43.2 (10.4)	43.1 (10.3)	45.1 (9.2)	44.4 (9)
SF-36 MCS	41 (12)	46.6 (11.6)	46 (11.8)	46.8 (11)	45.6 (11.5)	41.7 (11.5)	46.8 (11.1)	45.8 (11.6)	45.8 (10.7)	44.8 (11.3)	40.1 (12.6)	46.5 (12.2)	46.2 (12.1)	48.1 (11.4)	46.6 (11.6)

Note: Values are given as mean and (SD), unless stated otherwise.

Abbreviations: axSpA, axial spondyloarthritis; AS, ankylosing spondylitis; nr-axSpA, non-radiographic axial SpA; OC, observed cases; SF-36 PCS, Short Form (36) Health Survey Physical Component Summary; SF-36 MCS, Short Form (36) Health Survey Mental Component Summary.

Table 3 Effect of subcutaneous certolizumab pegol on peripheral arthritis and enthesitis in the RAPID-axSpA study²⁸

Articular manifestations, mean (SD)	All patients axSpA (N = 218)					AS (N = 121)					nr-axSpA (N = 97)
	Baseline	Week 24	Week 24	Week 204	Week 204	Baseline	Week 24	Week 24	Week 204	Week 204	Baseline	Week 24	Week 24	Week 204	Week 204
		OC	LOCF	OC	LOCF		OC	LOCF	OC	LOCF		OC	LOCF	OC	LOCF
Swollen joint count	N = 76 Mean 4.2 SD 5.6	N = 72 Mean 1.2 SD 2.7	N = 1.5 Mean 3.2	N = 52 Mean 0.4 SD 1.1	N = 0.8 Mean 2.4	N = 42 Mean 4 SD 4.6	N = 38 Mean 1.2 SD 1.9	N = 1.7 Mean 3.1	N = 28 Mean 0.1 SD 0.4	N = 1 Mean 3	N = 34	N = 34 Mean 4.5 SD 6.8	N = 1.2 Mean 3.4	N = 24 Mean 0.7 SD 1.5	Mean 2.6 SD 2.5
Tender joint count	N = 138 Mean 6.3 SD 7.1	N = 131 Mean 3.3 SD 6.4	N = 3.6 SD 6.5	N = 89 Mena 2.4 SD 5	N = 2.9 SD 5.5	N = 74 Mean 5.9 SD 6.5	N = 69 Mean 2.7 SD 4.7	N = 3 SD 4.8	N = 48 Mean 2.1 SD 5	N = 3 SD 5.7	N = 64 Mean 6.8 SD 7.7	N = 62 Mean 4.1 SD 7.8	N = 4.3 SD 8	N = 41 Mean 2.7 SD 5.1	N = 2.8 SD 5.3
Enthesitis MASES	N = 148 Mean 5.1 SD 3.5	N = 141 Mean 2.2	N = 2.3 SD 3.5	N = 104 Mean 1.4 SD 2.5	N = 1.7 SD 3	N = 78 Mean 4.7 SD 3.4	N = 74 Mean 1.6 SD 2.7	N =1.7 SD 2.7	N = 58 Mean 1.1 SD 2.2	N = 1.3 SD 2.5	N = 70 Mean 5.6 SD 3.6	N = 67 Mean 5.6 SD 3.6	N = 2.9 SD 4.1	N = 46 Mean 1.7 SD 2.9	N = 2.1 SD 3.4
Complete resolution of enthesitis MASES = 0, n/N (%)	0	74/141 (52.5)	75 (50.7)	66/104 (63.5)	90 (60.8)	0	41/74 (55.4)	42 (53.8)	38/58 (65.5)	51 (65.4)	0	33/67 (49.3)	33 (47.1)	28/46 (60.9)	39 (55.7)
Heel enthesitis complete resolution, n/N(%)	0	32/49 (65.3)	32 (61.5)	26/35 (74.3)	37 (71.2)	0	13/23 (56.5)	13 (52)	12/17 (70.6)	17 (68)	0	19/26 (73.1)	19 (70.4)	14/18 (77.8)	20 (74.1)

Abbreviations: axSpA, axial spondyloarthritis; AS, ankylosing spondylitis; nr-axSpA, non-radiographic axial SpA; OC, observed cases; LOCF, last observation carried forward.

van der HeijdeDDougadosMLandeweRSustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpARheumatology (Oxford)20175691498150928498975

 PubMed Web of Science ®Google Scholar

SieperJLandeweRRudwaleitMEffect of certolizumab pegol over ninety-six weeks in patients with axial spondyloarthritis: results from a phase III randomized trialArthritis Rheumatol201567366867725470228

 PubMed Web of Science ®Google Scholar

LandewéRBraunJDeodharAEfficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 studyAnn Rheum Dis2014731394724013647

 PubMed Web of Science ®Google Scholar

SieperJKivitzAvan TubergenAImpact of certolizumab pegol on patient-reported outcomes in patients with axial spondyloarthritisArthritis Care Res (Hoboken)201567101475148025832312

 PubMed Web of Science ®Google Scholar