Anti-IL-17A blockade did not significantly reduce inflammatory lesions in a placebo-controlled pilot study in adult patients with moderate to severe acne

Figures & data

Figure 1. CONSORT diagram. Flowchart demonstrating patient disposition in Treatment Period 1 (Weeks 0–12) and Treatment Period 2 (Weeks 12–24). Overall, 48/52 (92.3%) completed Treatment Period 1 and 41/52 (78.8%) entered Treatment Period 2.

Table 1. Baseline characteristics.

	CJM112 300 mg N = 21	CJM112 75 mg N = 13	Placebo N = 18	Total N = 52
Age, years, mean ± SD	23.8 ± 4.2	25.5 ± 6.0	23.9 ± 4.1	24.3 ± 4.6
Sex, male, n (%)	8 (38)	5 (38)	5 (28)	18 (35)
Race, n (%)
White	18 (86)	10 (77)	17 (94)	45 (87)
Other	3 (14)	3 (23)	1 (6)	7 (13)
Weight, kg, mean ± SD	69.5 ± 11.2	70.9 ± 12.2	64.7 ± 13.1	68.2 ± 12.2
BMI, kg/m^2, mean ± SD	23.4 ± 2.8	24.9 ± 3.6	22.8 ± 2.6	23.6 ± 3.0
Inflammatory facial lesion count, mean ± SD	42.0 ± 18.4	41.5 ± 15.5	40.9 ± 16.1	41.5 ± 16.6
Non-inflammatory facial lesion count, mean ± SD	43.8 ± 34.3	32.7 ± 20.1	40.3 ± 29.1	39.9 ± 29.3
Nodule count, mean ± SD	3.5 ± 7.0	3.8 ± 3.1	0.9 ± 1.6	2.7 ± 4.9
IGA grade (facial), n (%)
Moderate	16 (76)	8 (62)	13 (72)	37 (71)
Severe	5 (24)	5 (38)	5 (28)	15 (29)
CASS grade (non-facial), n (%)
Moderate	8 (38)	4 (31)	8 (44)	20 (38)
Severe	1 (5)	3 (23)	0 (0)	4 (8)

BMI: body mass index; CASS: Comprehensive Acne Severity Scale; IGA: Investigator’s Global Assessment; N: the total number of patients per group; n: number of patients with characteristic; SD: standard deviation.

Figure 2. Total inflammatory facial lesion counts up to Week 12. Line graph demonstrating the effect of CJM112 300 mg, CJM112 75 mg, and placebo on the total inflammatory facial lesion count in patients with moderate to severe inflammatory acne from baseline to Week 12. The log-transformed inflammatory facial lesion count was analyzed using a Bayesian model for repeated measurements. Data are demonstrated as geometric mean and 90% confidence intervals. Numbers, and the number of patients included in the analysis at each time point.

Table 2. Key efficacy endpoint results at Week 12.

	Baseline			Week 12
	CJM112 300 mg N = 21	CJM112 75 mg N = 13	Placebo N = 18	CJM112 300 mg N = 19	CJM112 75 mg N = 12	Placebo N = 17
Inflammatory lesion count (facial)
Mean ± SD	42.0 ± 18.4	41.5 ± 15.5	40.9 ± 16.1	27.6 ± 20.7	30.4 ± 34.8	23.6 ± 13.6
Absolute change from BL (mean ± SD)	–	–	–	–14.8 ± 23.3	–8.8 ± 33.5	–19.3 ± 16.6
Change (%) from BL (mean ± SD)	–	–	–	–32.1 ± 47.3	–24.5 ± 69.3	–43.0 ± 34.2
n (observed)	21	13	18	17	10	15
Non-inflammatory lesion count (facial)
Mean ± SD	43.8 ± 34.3	32.7 ± 20.1	40.3 ± 29.1	38.5 ± 24.9	29.8 ± 19.3	24.9 ± 13.6
Absolute change from BL (mean ± SD)	–	–	–	–8.6 ± 33.9	–2.9 ± 16.8	–21.9 ± 25.8
Change (%) from BL (mean ± SD)	–	–	–	+2.0 ± 63.8	+26.1 ± 107.5	–32.4 ± 42.6
n (observed)	21	13	18	17	10	15
Total nodule count (facial and non-facial)^a
Mean ± SD	3.5 ± 7.0	3.8 ± 3.1	0.9 ± 1.6	0.6 ± 1.1	1.4 ± 2.4	1.2 ± 1.4
Absolute change from BL (mean ± SD)	–	–	–	–3.5 ± 7.4	–2.5 ± 3.7	0.1 ± 1.6
n^b	21	13	18	17	10	15
SER
Mean ± SD	104.8 ± 45.4	122.5 ± 39.8	132.5 ± 62.3	101.8 ± 44.2	76.3 ± 29.0	93.1 ± 49.6
Absolute change from BL (mean ± SD)	–	–	–	–28.7 ± 60.7	–43.6 ± 28.3	–29.8 ± 37.7
Change (%) from BL (mean ± SD)	–	–	–	–15.1 ± 38.2	–35.6 ± 20.5	–21.3 ± 41.4
n (observed)	15	8	14	14	5	12
DLQI total score
Mean ± SD	7.0 ± 4.9	8.8 ± 5.7	7.8 ± 7.1	4.3 ± 5.3	7.3 ± 7.1	5.7 ± 5.5
n (observed)	21	13	18	17	10	14

BL: baseline; DLQI: Dermatology Life Quality Index; SER: sebum excretion rate; SD: standard deviation; N: the total number of patients per group; n: number of patients completing the assessment at specific time points (as observed).

^a,bOnly absolute change from BL and n (and not n observed) is demonstrated as there was an imbalance in nodule count at BL, with less patients in the placebo group demonstrating nodules at BL.

Table 3. Incidence of adverse events in Treatment Period 1.

	CJM112 300 mg N = 21	CJM112 75 mg N = 13	Placebo N = 18	CJM112 pooled N = 34	Total N = 52
Patients with at least 1 AE	16 (76.2)	11 (84.6)	10 (55.6)	27 (79.4)	37 (71.2)
Infections and infestations (system organ class)	7 (33.3)	8 (61.5)	3 (16.7)	15 (44.1)	18 (34.6)
AE by preferred term (Preferred Term)^a
Headache	1 (4.8)	3 (23.1)	1 (5.6)	4 (11.8)	5 (9.6)
Nasopharyngitis	3 (14.3)	1 (7.7)	1 (5.6)	4 (11.8)	5 (9.6)
Dry skin	2 (9.5)	0	2 (11.1)	2 (5.9)	4 (7.7)
Pruritus	1 (4.8)	0	3 (16.7)	1 (2.9)	4 (7.7)
Diarrhea	1 (4.8)	0	2 (11.1)	1 (2.9)	3 (5.8)
Upper respiratory tract infection	1 (4.8)	2 (15.4)	0	3 (8.8)	3 (5.8)
Urinary tract infection	1 (4.8)	1 (7.7)	1 (5.6)	2 (5.9)	3 (5.8)
Acne	0	2 (15.4)	0	2 (5.9)	2 (3.8)
Back pain	0	1 (7.7)	1 (5.6)	1 (2.9)	2 (3.8)

AEs: adverse events.

^a Only AEs with >1 case in any group are listed. AEs were reported using the Medical Dictionary for Regulatory Activities (MedDRA).

Data availability statement

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.