Efficacy and safety of adalimumab in Japanese patients with psoriatic arthritis and inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs): A prospective, observational study

Figures & data

Figure 1. Patient disposition. Three patients were excluded as they did not meet the inclusion criteria (not meeting the CASPAR criteria, n = 1; not having received treatment at a stable dose of NSAIDs, DMARDs, or oral corticosteroids for at least 4 weeks before study start, n = 2). CASPAR: ClASsification criteria for Psoriatic Arthritis; DMARDs: disease-modifying antirheumatic drugs; NSAIDs: nonsteroidal anti-inflammatory drugs.

Table 1. Patient demographics and baseline characteristics (FAS population).

Characteristic	All patients N = 37	With previous use of biologics n = 9	Without previous use of biologics n = 28
Age (years), mean (SD)	56.2 (13.0)	57.0 (11.4)	55.9 (13.6)
Sex (male), n (%)	27 (73.0)	6 (66.7)	21 (75.0)
Height (cm), mean (SD)	164.88 (8.95)	162.94 (9.95)	165.50 (8.71)
Weight (kg), mean (SD)	67.27 (11.03)	67.31 (15.99)	67.26 (9.31)
Body surface area (m^2), mean (SD)	22.0 (24.0)	16.8 (22.2)	23.6 (24.7)
Smoking, n (%)	13 (35.1)	3 (33.3)	10 (35.7)
PsA duration (months), mean (SD)	119.4 (99.8)	128.3 (69.1)	116.5 (108.7)
Rheumatoid factor (IU/mL), mean (SD)	10.6 (14.9)	6.2 (3.2)	12.0 (16.8)
Number of tender joints (68-joint count), mean (SD)	10.7 (12.3)	7.9 (7.9)	11.6 (13.3)
Number of swollen joints (66-joint count), mean (SD)	10.8 (11.1)	8.4 (6.2)	11.5 (12.2)
Patients with comorbidities, n (%)	29 (78.4)	5 (55.6)	24 (85.7)
Concomitant medications, n (%)	37 (100.0)	9 (100.0)	28 (100.0)
NSAIDs	22 (59.5)	7 (77.8)	15 (53.6)
DMARDs	10 (27.0)^a	5 (55.6)	5 (17.9)
Biologics	9 (24.3)	9 (100.0)	0
Moll and Wright classification, n (%)
Asymmetric oligoarthritis	8 (21.6)	3 (33.3)	5 (17.9)
Symmetric polyarthritis	11 (29.7)	4 (44.4)	7 (25.0)
Spondylitis	8 (21.6)	0	8 (28.6)
Distal interphalangeal arthropathy	9 (24.3)	2 (22.2)	7 (25.0)
Arthritis mutilans	1 (2.7)	0	1 (3.6)
Area of inflammation, n (%)
Spondylitis	20 (54.1)	5 (55.6)	15 (53.6)
Cervical spine	20 (54.1)	4 (44.4)	16 (57.1)
Lumbar spine	15 (40.5)	3 (33.3)	12 (42.9)
Sacroiliac joints	17 (45.9)	2 (22.2)	15 (53.6)
Right fingers	20 (54.1)	5 (55.6)	15 (53.6)
Left fingers	21 (56.8)	4 (44.4)	17 (60.7)
Right toes	14 (37.8)	3 (33.3)	11 (39.3)
Left toes	9 (24.3)	2 (22.2)	7 (25.0)
Right Achilles tendon attachment	6 (16.2)	1 (11.1)	5 (17.9)
Left Achilles tendon attachment	6 (16.2)	1 (11.1)	5 (17.9)

DMARDs: disease-modifying antirheumatic drugs; FAS: full analysis set; NSAIDs: nonsteroidal anti-inflammatory drugs; PsA: psoriatic arthritis; SD: standard deviation.

^aSulfasalazine 1000 mg (n = 1), methotrexate (2 mg/week (n = 1), 6 mg/week (n = 1), 7.5 mg/week (n = 1), 8 mg/week (n = 4), and alternate use of 2 and 4 mg/week (n = 1)), and a combination of sulfasalazine 1000 mg and methotrexate 12 mg/week (n = 1).

Figure 2. Efficacy outcomes during treatment of psoriatic arthritis with adalimumab (FAS population). (a) Percentage of patients with psoriatic arthritis who met the ACR20, ACR50, and ACR70 response criteria at weeks 12 and 24. (b) Subanalysis of the percentage of patients with psoriatic arthritis who met the ACR20, ACR50, and ACR70 response criteria at weeks 12 and 24 by previous use of biologics. (c) Percentage of patients with psoriatic arthritis who met the PASI50, PASI75, and PASI90 response criteria at weeks 12 and 24. (d) Subanalysis of the percentage of patients with psoriatic arthritis who met the PASI50, PASI75, and PASI90 response criteria at weeks 12 and 24 by previous use of biologics. (e) PGA scores in patients with psoriatic arthritis at weeks 12 and 24. ACR: American College of Rheumatology; CI: confidence interval; FAS: full analysis set; PASI: Psoriasis Area and Severity Index; PGA: Physician’s Global Assessment.

Figure 3. DAS-28CRP (a) and BASDAI (b) scores at weeks 12 and 24 (FAS population). BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; DAS-28CRP: Disease Activity Score-28 CRP; FAS: full analysis set.

Table 2. Serum biomarker levels at weeks 12 and 24.

	Anti-CCP antibody, U/mL			SAA, µg/mL			MMP-3, ng/mL			CRP, mg/dL
	Baseline	Week 12	Week 24	Baseline	Week 12	Week 24	Baseline	Week 12	Week 24	Baseline	Week 12	Week 24
N	37	36	33	37	35	33	37	36	33	37	36	32
Serum biomarker level, mean (SD)	0.74 (0.77)	0.59 (0.05)	0.58 (0.04)	104.46 (205.36)	17.27 (52.91)	18.56 (55.15)	148.64 (177.14)	70.14 (41.81)	60.99 (31.75)	0.48 (7.75)	0.10 (5.35)	0.08 (4.55)
p value	–	.238	.2217	–	.022	.037	–	.0076	.0083	–	<.0001	<.0001

CCP: cyclic citrullinated peptide; CRP: C-reactive protein; MMP-3: matrix metalloproteinase; SAA: serum amyloid protein A; SD: standard deviation.

Figure 4. (a) HAQ-DI at weeks 12 and 24. (b) SF-36 scores at weeks 12 and 24. (c) DLQI at weeks 12 and 24 (FAS population). DLQI: Dermatology Life Quality Index; FAS: full analysis set; HAQ-DI: Health Assessment Questionnaire Disability Index; SF-36: Short Form Survey 36 items.

Table 3. Commonly (≥5%) reported adverse events.

	Adverse event N = 37 n (%)
Elevated liver enzymes	5 (13.5)
Abnormal KL-6	2 (5.4)
LDH increase	2 (5.4)
Pharyngitis	2 (5.4)
Worsening of the primary condition	2 (5.4)
Ringworm	2 (5.4)
Headache	2 (5.4)
Fever	2 (5.4)

KL-6: Krebs von den Lungen-6; LDH: lactate dehydrogenase.