One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study

Figures & data

Table 1. Baseline clinical and serological characteristics of patients.

	All patients (n = 169)	AS (n = 39)	PsA (n = 130)
Age, years	52.8 ± 12.2	44.8 ± 13.7	55 ± 10.7
M/F	82/87	20/19	62/68
Disease duration, months	150.4 ± 107.6	150.9 ± 89.5	150.3 ± 112.8
Diagnostic delay, months	43.7 ± 62.5	49.2 ± 67.8	39.2 ± 60.9
Axial disease, n (%)	101 (59.7%)	39 (100%)	62 (47.7%)
Peripheral disease, n (%)	138 (81.7%)	14 (35.9%)	124 (95.4%)
Erosive disease, n (%)	26 (15.4%)	3 (7.7%)	23 (17.7%)
Tender joint count	8.4 ± 7.5	11.7 ± 7.4	8.4 ± 7.5
Swollen joint count	2.4 ± 3.5	2.4 ± 3.5	2.4 ± 3.5
Enthesitis, n (%)	57 (33.7%)	11 (28.2%)	46 (35.4%)
LEI	0.48 ± 0.68	0.55 ± 0.63	0.46 ± 0.69
Dactylitis, n (%)	63 (37.3%)	9 (23.0%)	54 (41.5%)
PsO, n (%)	105 (62.2%)	5 (12.8%)	100 (76.9%)
Nail involvement, n (%)	39 (23.1%)	1 (2.6%)	38 (29.2%)
ESR	19.8 ± 17.9	26.7 ± 19.7	18.1 ± 17.1
CRP	2.1 ± 6.7	1.2 ± 1.6	2.4 ± 7.5
DAPSA	25.5 ± 9.3	26.7 ± 19.7	25.8 ± 9.5
BASDAI	5.9 ± 2	5.5 ± 2	6 ± 2.1
ASDAS-CRP	3 ± 1.2	2.7 ± 1	3.1 ± 1.3
Inactive IBD, n (%)	2 (1.2%)	0 (0%)	2 (1.5%)
Inactive uveitis, n (%)	6 (3.6%)	4 (10.3%)	2 (1.5%)
HLA-B27 positive, n (%)	18 (10.7%)	12 (30.8%)	6 (4.6%)
BMI	25.7 ± 4.1	24.4 ± 4.2	25.9 ± 4.1
Smoking, n (%)	33 (19.5%)	8 (20.5%)	25 (19.2%)
Cardiovascular comorbidities, n (%)	26 (15.4%)	8 (20.5%)	18 (13.8%)
Metabolic comorbidities, n (%)	33 (19.5%)	9 (23.0%)	24 (18.5%)
Psychiatric comorbidities, n (%)	16 (9.5%)	2 (5.2%)	14 (10.7%)
Neurologic comorbidities, n (%)	8 (4.7%)	1 (2.6%)	7 (5.4%)
Concomitant csDMARD, n (%)	59 (34.9%)	8 (20.5%)	51 (39.2%)
Concomitant glucocorticoids, n (%)	41 (24.3%)	6 (15.4%)	35 (26.9%)
Concomitant NSAIDs, n (%)	59 (34.9%)	15 (38.5%)	44 (33.8%)
Secukinumab dosage 300 mg, n (%)	103 (60.9%)	NA	103 (79.2%)
Biologic-naïve, n (%)	35 (20.7%)	8 (20.6%)	27 (20.8%)
SEC as second line, n (%)	46 (27.2%)	13 (33.3%)	33 (25.4%)
SEC as third line, n (%)	52 (30.8%)	11 (28.2%)	41 (31.5%)
SEC as fourth line or more, n (%)	36 (21.3%)	7 (17.9%)	29 (22.3%)

Data are expressed as mean ± standard deviation unless otherwise specified.

Legend: AS Ankylosing Spondylitis; PsA Psoriatic Arthritis; IBD inflammatory bowel disease, PASI Psoriasis Area Severity Index, DAPSA Disease Activity Index for Psoriatic Arthritis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, ASDAS-CRP Ankylosing Spondylitis Disease Activity Score with CRP, ESR erythrocyte sedimentation rate, CRP C-reactive protein, BMI body mass index, NSAIDs nonsteroidal anti-inflammatory drugs, csDMARDs conventional synthetic disease-modifying anti-rheumatic drugs, SEC secukinumab.

Figure 1. Evaluation of joint count and inflammatory markers during follow-up in patients with PsA and AS pooled together. T0: 169 patients, T6: 145 patients, and T12: 129 patients. The Wilcoxon test was used to compare matched values (T0, T6, and T12).

Figure 2. Evaluation of DAPSA during follow-up in patients with PsA. T0: 130 patients, T6: 109 patients, and T12: 99 patients. The Wilcoxon test was used to compare paired disease activity scores at different time points (T0, T6, and T12).

Figure 3. Evaluation of BASDAI (Panel A) and ASDAS-CRP (Panel B) during follow-up. BASDAI Bath Ankylosing Spondylitis Disease Activity Index, ASDAS-CRP Ankylosing Spondylitis Disease Activity Score with C-reactive protein. T0: 169 patients, T6: 145 patients, and T12: 129 patients. The paired scores at T0, T6, and T12 were compared using the Wilcoxon test in patient with PsA and AS, pooled together.

Figure 4. Twelve months retention rate of secukinumab in AS and PsA patients according to gender. Panel A. Global retention rate (T0: 169 patients, T6: 145 patients, and T12: 129 patients); Panel B. Global retention rate according to gender (T0: 169 patients, T6: 145 patients, and T12: 129 patients); Panel C. Retention Rate according to gender in AS patients T0: 39 patients, T6: 36 patients, and T12: 30 patients.; Panel D. Retention Rate according to gender in PsA patients (T0: 130 patients, T6: 109 patients, and T12: 99 patients).

Figure 5. Twelve months retention rate of secukinumab in AS and PsA patients according to BMI and to line of biologics. Panel A. Retention Rate according to BMI (T0: 169 patients, T6: 145 patients, and T12: 129 patients); Panel B. Retention Rate according to lines of biologics (T0: 169 patients, T6: 145 patients, and T12: 129 patients); Panel C. Retention Rate according to the presence or absence of Methotrexate (T0: 169 patients, T6: 145 patients, and T12: 129 patients).

Table 2. Causes of treatment discontinuation in the study population.

	All patients (n = 40)	AS (n = 9)	PsA (n = 31)
Lack of efficacy, n (%)	26 (65%)	8 (89%)	18 (58%)
Pregnancy, n (%)	1 (2.5%)	1 (11%)	0
Occurrence of IBD^a, n (%)	1 (2.5%)	0	1 (3.2%)
Dental treatments, n (%)	2 (5%)	0	2 (6.5%)
Allergy/intolerance, n (%)	5 (12.5%)	0	5 (16.1%)
Pulmonary nodule evaluation, n (%)	1 (2.5%)	0	1 (3.2%)
Infectious disease^b, n (%)	3 (7.5%)	0	3 (9.7%)
Increase in transaminases, n (%)	1 (2.5%)	0	1 (3.2%)

Legend: AS Ankylosing Spondylitis; PsA Psoriatic Arthritis; IBD inflammatory bowel disease.

^aNew onset of IBD; ^bInfections of the upper respiratory tract.