Real-world outcomes and drug survival of brodalumab: results from the German Psoriasis Registry PsoBest

Figures & data

Table 1. Patient characteristics at baseline.

	Total (N = 227)	Pso (N = 189)	PsA (N = 38)	Pso vs PsA p- value
Mean age, y (SD)	49.9 (14.6)	49.1 (14.8)	53.8 (13.2)	0.069
Female, %	30.8	29.1	39.5	0.206
Mean duration of disease, y (SD)	22.0 (15.7), n = 211	20.6 (14.9), n = 174	28.3 (18.0), n = 37	0.007
Prior systemic therapy but no prior biologic therapy*, %	55.1	56.6	47.4	0.296
Prior biologic therapy*, %	31.7	30.2	39.5	0.260
No prior systemic therapy*, %	13.2	13.2	13.2	0.991
Prior (additional) phototherapy*, %	44.1	45.5	36.8	0.326
Mean PASI (SD)	18.0 (11.0), n = 224	18.4 (10.8), n = 186	16.0 (11.8)**	0.222
Mean BSA involvement, % (SD)	29.6 (21.4), n = 214	29.7 (20.2), n = 177	29.6 (26.9), n = 37	0.983
Mean DLQI (SD)	12.5 (7.5), n = 220	12.7 (7.3), n = 183	11.4 (8.5), n = 37	0.342
Mean VAS (SD)	4.2 (2.5), n = 37	–	4.2 (2.5), n = 37	–
Mean number of swollen joints (SD)	7.2 (12.5), n = 31	–	7.2 (12.5), n = 31	–
Mean number of tender joints (SD)	8.6 (13.1), n = 34	–	8.6 (13.1), n = 34	–

*Non-biologics: Apremilast, Cyclosporine, Dimethylfumarate, Fumaric Acid Esters, Leflunomid, Methotrexate, Retinoids, Tofacitinib, systemic psoralen plus UV-A therapy. Biologics: Abatacept, Adalimumab, Certolizumab, Efalizumab, Etanercept, Golimumab, Guselkumab, Infliximab, Ixekizumab, Risankizumab, Secukinumab, Tildrakizumab, Ustekinumab and all biosimilars licensed in Germany. Phototherapy: UV, systemic psoralen plus UV-A. If a patient received a medication out of the non-biologic and the biologic group, the prior treatment was categorized as "prior biologic therapy." If the prior treatment was counted in the category "no prior systemic therapy," the patient received neither a medication of the non-biologic or biologic group. **n is given within cells only if sample size differs from cohort size (= N).

Significant p-values (p ≤ 0.05) from Chi²- and t-test are marked bold.

BSA, body surface area (range 0-100); DLQI, Dermatology Life Quality Index (range 0-30); n, number of patients in analysis set; PASI, Psoriasis Area and Severity Index (range 0-72); PsA, psoriatic arthritis; Pso, psoriasis; SD, standard deviation; VAS, Visual Analogue Scale (range 0-10); y, years.

Figure 1. Mean (a) PASI (0-72) and (b) BSA (0-100) scores at 3, 6, and 12 months.

Error bars depict standard error. The number of patients at each time point are represented within each respective bar.

BSA, body surface area (range 0-100); PASI, Psoriasis Area and Severity Index (range 0-72); PsA, psoriatic arthritis; Pso, psoriasis; SE, standard error.

Figure 2. Proportions of patients achieving (a) PASI-75, (b) PASI-90, and (c) PASI-100 at 3, 6, and 12 months.

The number of patients at each time point are represented within each respective bar.

PASI, Psoriasis Area and Severity Index (range 0-72); PASI-75, at least 75% reduction from baseline PASI; PASI-90, at least 90% reduction from baseline PASI; PASI-100, 100% reduction from baseline PASI; PsA, psoriatic arthritis; Pso, psoriasis.

Figure 3. Mean (a) PsA severity (VAS 0-10) and (b) number of swollen (0-74) and number of tender (0-76) joints in PsA patients at 0, 3, 6, and 12 months.

Error bars depict standard error. The number of patients at each time point are represented within each respective bar.

PsA, psoriatic arthritis; SE, standard error; VAS, Visual Analogue Scale.

Figure 4. Mean (a) DLQI (0-30) and (b) PBI (0-4) and proportions of patients achieving (c) DLQI 0/1, (d) PBI $\ge$1 and PBI $\ge$3 at 0, 3, 6, and 12 months.

The number of patients at each time point are represented within each respective bar. For mean DLQI and PBI, error bars depict standard error.

DLQI, Dermatology Life Quality Index; PBI, Patient Benefit Index; PsA, psoriatic arthritis; Pso, psoriasis; SE, standard error.

Table 2. Time to discontinuation (for cases with reported stop).

		n	Min	Max	Mean	Median	SD
Total (n = 227)	time to discontinuation [months]	41	1.2	34.5	8.3	5.8	6.9
Pso (n = 189)	time to discontinuation [months]	34	1.2	34.5	8.0	5.8	6.6
PsA (n = 38)	time to discontinuation [months]	7	1.9	25.5	9.7	9.1	8.5

n, number of patients in analysis set; PsA, psoriatic arthritis; Pso, psoriasis, SD, standard deviation.

Table 3. Reasons for discontinuation of brodalumab.

Reason*	Total (n = 227)		Pso (n = 189)		PsA (n = 38)
	n	%	n	%	n	%
Stop due to adverse events	12	27.3	11	30.6	1	12.5
Stop due to onset of contraindication	3	6.8	3	8.3	0	0
Stop due to skin clearance	2	4.5	2	5.6	0	0
Stop due to lack or loss of effectiveness	21	47.7	15	41.7	6	75.0
Stop due to other reason	1	2.3	1	2.8	0	0
Stop due to unknown reason	5	11.4	4	11.1	1	12.5
Total reported reasons	44	100.0	36	100.0	8	100.0

*Multiple reasons possible. PsA, psoriatic arthritis; Pso, psoriasis.

Table 4. Adverse events as reason for discontinuation.

Pseudo ID	Severity	MedDRA SOC	MedDRA PT	Days to event	Result	Causality	Comment
1	unknown	unknown	unknown	–	unknown	unknown	Not determinable by query
2	unknown	unknown	unknown	–	unknown	unknown	Not determinable by query
3	non severe	Psychiatric disorders	Listless	154	not yet recovered	possibly related
	non severe	Metabolism and nutrition disorders	Decreased appetite	154	not yet recovered	possibly related
4	non severe	Reproductive system and breast disorders	Orchitis noninfective	73	recovered	possibly related
5	non severe	Musculo- skeletal and connective tissue disorders	Musculo- skeletal discomfort	115	recovered	probably related
6	non severe	Psychiatric disorders	Depression	50	not yet recovered	possibly related
7	non severe	Nervous system disorders	Headache	43	not yet recovered	probably related
	non severe	Skin and subcutaneous tissue disorders	Pruritus	57	recovered	related
8	non severe	Gastrointestinal disorders	Diarrhoea	140	not yet recovered	probably related
9	non severe	Skin and subcutaneous tissue disorders	Erythema	74	not yet recovered	probably related	PsA
	non severe	Skin and subcutaneous tissue disorders	Pruritus	74	not yet recovered	probably related	PsA
	non severe	Skin and subcutaneous tissue disorders	Rash	74	not yet recovered	probably related	PsA
10	severe	Surgical and medical procedures	Knee arthroplasty	285	recovered	improbable
11	severe	Skin and subcutaneous tissue disorders	Pyoderma gangrenosum	35	not recovered	related
	severe	Skin and subcutaneous tissue disorders	Palmoplantar pustulosis	35	not recovered	related
	severe	Infections and infestations	Arthritis bacterial	80	not recovered	related
12	severe	Infections and infestations	Herpes zoster meningitis	350	recovered	possibly related	First treatment period
	severe	Infections and infestations	Ophthalmic herpes zoster	350	recovered	possibly related	First treatment period
	severe	Infections and infestations	Infective episcleritis	4	recovered	possibly related	Second treatment period

MedDRA, Medical Dictionary for Regulatory Activities; PsA, psoriatic arthritis; PT, preferred term; SOC, system organ class.

Figure 5. Time on brodalumab over 12 months.

Tick marks on connecting lines represent incidences/time points of censoring (i.e. last time of observation, not treatment stop).

PsA, psoriatic arthritis; Pso, psoriasis.

Table 5. Drug survival rate.

Month	Total cohort (n = 227)		Pso (n = 189)		PsA (n = 38)
	Drug survival rate (%)	Patients remaining at risk	Drug survival rate (%)	Patients remaining at risk	Drug survival rate (%)	Patients remaining at risk
3	96.6	162	97.3	136	92.9	26
6	86.4	111	85.8	93	89.1	24
12	76.2	71	74.9	58	83.2	13

n, number of patients in analysis set; PsA, psoriatic arthritis; Pso, psoriasis.

Data availability statement

The data that support the findings of this study are available from the corresponding author, Nesrine Ben-Anaya upon reasonable request.