Secukinumab in moderate-to-severe plaque psoriasis: a multi-center, retrospective, real-life study up to 52 weeks observation

Figures & data

Table 1. Patient demographics and disease characteristics at baseline.

Characteristic	N = 107
Male/female, n	80/27
	Mean ± Standard deviation (range)	Median (interquartile range)
Age, years	47.5 ± 12.8 (20–74)	49 (38–56)
BMI, kg/m^2 Male Female	27.9 ± 6.5 28.3 ± 6.9 26.9 ± 5.2	27 (24–29) 27 (24.75–53) 26 (22–29)
Age at disease onset, years	27.2 ± 12.6 (6.0–63.0)	27 (17.5–35)
Duration of psoriasis, years	20.3 ± 12.3 (1.0–48.0)	18 (10–29)
PASI	17.9 ± 11.2 (2.9–56.7)	15 (10–23.5)
Comorbidities, n
Hypertension	16
Type 2 diabetes mellitus	11
Hyperlipidemia	14
Chronic autoimmune thyroiditis	5
Hyperuricemia	7
Psychiatric diseases	4
Bipolar disorder	2
Depressive disorder	1
Anxiety disorder	1
Obesity	25
Class I (BMI 30.0–34.9 kg/m^2)	17
Class II (BMI 35.0–39.9 kg/m^2)	4
Class III (BMI ≥40.0 kg/m^2)	4
Concomitant psoriatic arthritis	N = 16
Male/female, n	9/7
	Mean ± Standard deviation (range)	Median (interquartile range)
Age, years	50.2 ± 12.5 (25–67)	52 (43.2–59.75)
Age at disease onset, years	36.1 ± 9.7 (6.0–63.0)	35 (29–40.5)
Duration of psoriasis, years	20.3 ± 12.2 (23.0–54.0)	27 (17.5–35)
PASI at baseline	15.0 ± 8.1 (2.9–32)	14 (11–18.25)
DAS 44	3.17 ± 1.1 (1.5 ± 4.8)	2.9 (2–4)
VASp	60.5 ± 24.4 (20–100)	65 (47.5–70)

BMI: body mass index; DAS: Disease Activity Score; PASI: Psoriasis Area and Severity Index; VASp: Visual Analog Scale of pain.

Figure 1. Proportion of patients achieving a 75% reduction in Psoriasis Area Severity Index (PASI) scores (PASI75), a 90% reduction in PASI (PASI90) and a 100% reduction in PASI (PASI100) during the 52 weeks of secukinumab treatment.

Figure 2. Proportion of patients naïve to biological therapies (naïve) and patients with prior exposure to biologics (PBT) achieving (a) 75% reduction in Psoriasis Area Severity Index (PASI) scores (PASI75), (b) 90% reduction in PASI (PASI90), and (c) 100% reduction in PASI (PASI100) during the 52 weeks of treatment with secukinumab.

Table 2. Univariate logistic regression analysis on PASI75, PASI90, and PASI100 response.

	OR	SE	z	P > |z|	95% CI	Number of observations	LR χ^2	Prob > χ^2	Pseudo R^2	Log likelihood
Week 4
PASI75
Naïve/PBT	0.30	0.12	−2.91	0.004	0.14–0.68	107	8.88	0.0029	0.0610	−68.371691
Age	0.97	0.02	−1.96	0.050	0.94–1.00	107	4.03	0.0447	0.0280	−69.922471
Comorbidities	0.96	0.26	−0.13	0.893	0.57–1.62	107	5.70	0.0169	0.0501	−54.10448
PASI90
Naïve/PBT	0.24	0.11	−3.19	0.001	0.10–0.58	107	11.11	0.0009	0.0798	−64.057044
Age	0.95	0.02	−3.02	0.003	0.92–0.98	107	10.22	0.0014	0.0738	−64.062201
Comorbidities	0.65	0.19	−1.46	0.144	0.37–1.16	107	2.25	0.1335	0.0162	−68.485179
PASI100
Naïve/PBT	0.28	0.15	−2.44	0.015	0.10–0.78	107	6.64	0.0100	0.0583	−53.637467
Age	0.95	0.02	−2.79	0.005	0.91–0.98	107	8.64	0.0033	0.0762	−52.382377
Comorbidities	0.42	0.17	−2.15	0.031	0.19–0.92	107	5.70	0.0169	0.0501	−54.10448
Week 12
PASI75
Naïve/PBT	0.10	0.08	−2.84	0.005	0.02–0.50	78	11.64	0.0006	0.1454	−34.210704
Age	0.98	0.02	−0.88	0.381	0.94–1.02	78	0.79	0.3735	0.0099	−39.411548
Comorbidities	0.97	0.35	−0.07	0.942	0.48–1.98	78	0.01	0.9419	0.0001	−40.029542
PASI90
Naïve/PBT	0.19	0.10	−3.05	0.002	0.07–0.55	78	10.59	0.0011	0.1050	−45.150436
Age	0.96	0.02	−1.96	0.050	0.92–1.00	78	4.21	0.0401	0.0421	−47.943233
Comorbidities	0.96	0.26	−0.13	0.893	0.57–1.62	78	3.50	0.0613	0.0347	−48.69605
PASI100
Naïve/PBT	0.39	0.18	−2.03	0.043	0.16–0.97	78	10.69	0.0011	0.1430	−32.022126
Age	0.97	0.02	−1.87	0.061	0.93–1.00	78	3.74	0.0530	0.0344	−52.576714
Comorbidities	0.45	0.14	−2.54	0.011	0.24–0.83	78	7.00	0.0082	0.0636	−51.55162
Week 24
PASI75
Naïve/PBT	0.11	0.09	−2.75	0.006	0.02–0.53	68	10.69	0.0011	0.1430	−32.022126
Age	0.97	0.02	−1.21	0.228	0.93–1.02	68	1.55	0.2133	0.0209	−36.325861
Comorbidities	1.01	0.38	0.02	0.987	0.48–2.12	68	0.00	0.9868	0.0000	−37.366322
PASI90
Naïve/PBT	0.12	0.08	−3.05	0.002	0.03–0.47	68	12.12	0.0005	0.1459	−35.480823
Age	0.97	0.02	−1.35	0.177	0.93–1.01	68	1.94	0.1634	0.0236	−40.222763
Comorbidities	0.72	0.25	−0.95	0.344	0.37–1.42	68	0.88	0.3472	0.0106	−41.097618
PASI100
Naïve/PBT	0.33	0.17	−2.14	0.032	0.12–0.91	68	4.82	0.0281	0.0513	−44.536851
Age	0.96	0.02	−1.88	0.060	0.92–1.00	68	3.84	0.0500	0.0414	−44.475086
Comorbidities	0.34	0.12	−2.94	0.003	0.17–0.70	68	9.93	0.0016	0.1058	−41.980257
Week 36
PASI75
Naïve/PBT	0.22	0.19	−1.73	0.083	0.04–1.22	46	3.44	0.0636	0.0810	−19.532896
Age	1.00	0.03	0.04	0.968	0.94–1.06	46	0.00	0.9685	0.0000	−21.059537
Comorbidities	1.00	0.57	0.00	1.000	0.33–3.05	46	0.00	1.0000	0.0000	−21.253698
PASI90
Naïve/PBT	0.12	1.00	−2.51	0.012	0.02–0.62	46	7.99	0.0047	0.1578	−21.310304
Age	0.99	0.03	−0.26	0.792	0.94–1.05	46	0.07	0.7916	0.0014	−24.991808
Comorbidities	0.44	0.21	−1.70	0.089	0.17–1.13	46	2.94	0.0865	0.0581	−23.833939
PASI100
Naïve/PBT	0.21	0.15	−2.24	0.025	0.05–0.82	46	5.49	0.0192	0.0970	−25.524019
Age	0.98	0.03	−0.84	0.402	0.93–1.03	46	0.73	0.3933	0.0131	−27.535035
Comorbidities	0.34	0.17	−2.21	0.027	0.13–0.89	46	5.30	0.0213	0.0938	−25.616662
Week 52
PASI75
Naïve/PBT	0.30	0.38	−0.96	0.338	0.02–3.59	38	0.98	0.3214	0.0469	−10.00355
Age	1.08	0.05	1.48	0.140	0.98–1.19	38	2.58	0.1085	0.1227	−9.2072589
Comorbidities	0.63	0.50	−0.58	0.565	0.14–2.98	38	0.31	0.5772	0.0148	−10.339843
PASI90
Naïve/PBT	0.19	0.18	−1.80	0.072	0.03–1.16	38	3.62	0.0571	0.0997	−16.342814
Age	1.00	0.03	−0.12	0.907	0.94–1.06	38	0.01	0.9066	0.0004	−18.14641
Comorbidities	0.38	0.22	−1.68	0.094	0.13–1.18	38	2.81	0.0935	0.0775	−16.746994
PASI100
Naïve/PBT	0.30	0.25	−1.46	0.145	0.06–1.52	38	2.21	0.1374	0.0564	−18.453597
Age	0.98	0.03	−0.57	0.569	0.93–1.04	38	0.33	0.5638	0.0085	−19.390207
Comorbidities	0.35	0.20	−1.88	0.060	0.12–1.04	38	3.66	0.0558	0.0935	−17.728104

Figures in bold represent significant results.

CI: confidence interval; OR: odds ratio; PBT: previous biological therapies; SE: standard error.

Figure 3. Proportion of patients achieving (a) 75% reduction in Psoriasis Area Severity Index (PASI) scores (PASI75), (b) 90% reduction in PASI (PASI90), and (c) 100% reduction in PASI (PASI100) during the 52 weeks of secukinumab treatment, according to the number of previous biological therapies (PBT).

Table 3. Adverse events during secukinumab exposure period.

AE	Therapy	Outcome
Cutaneous mycosis	Itraconazole 100 mg PO BID for 2 weeks	Resolution
Oral candidiasis	Nystatin suspension 1 mL TID for 10 days/month for 3 months	Resolution
Cutaneous mycosis	Itraconazole 100 mg PO BID for 10 days/month for 3 months	Resolution
Oral candidiasis	Nystatin suspension 1 mL TID for 10 days/month for 3 months	Resolution
Oral candidiasis	Nystatin suspension 1 mL TID for 10 days/month for 3 months	Resolution
Oral candidiasis	Itraconazole 100 mg PO TID for 2 weeks, then 100 mg/week for 1 month then discontinuation of secukinumab	After 1 month, the patient showed a complete resolution of oral candidiasis
Oral candidiasis	Nystatin suspension 1 mL TID for 14 days, then itraconazole 100 mg PO BID for 20 days then discontinuation of secukinumab	After 1 month, the patient showed a complete resolution of oral candidiasis
Increased transaminases (>3 × ULN)	Discontinuation of secukinumab	After 2 months, the patient showed a complete resolution of AE
Appetite decrease and severe weight loss	Discontinuation of secukinumab	After 3 months, the patient showed a complete resolution of AEs
Recurrent upper respiratory tract infection	Discontinuation of secukinumab	After 3 months, the patient showed a complete resolution of AE

AE: adverse event; BID: twice daily; PO: per os (i.e. oral); TID: three times a day; ULN: upper limit of normal.