. 2019 Dec 26;156(2):131–143. doi: 10.1001/jamadermatol.2019.3617

Table 2. Dupilumab Efficacy.

End Point	Placebo (n = 83)	Dupilumab, 300 mg
End Point	Placebo (n = 83)	Every 8 wk (n = 84)	Every 4 wk (n = 86)	Weekly or Every 2 wk (n = 169)
Coprimary end points
Percent change in EASI score from SOLO baseline: difference between SOLO-CONTINUE baseline and week 36, LS mean (SE)	−21.67 (3.13)	−6.84 (2.43)^a	−3.84 (2.28)^a	−0.06 (1.74)^a
Patients with EASI-75 at week 36 among patients with EASI-75 at SOLO-CONTINUE baseline, No./total No. (%)	24/79 (30.4)	45/82 (54.9)^b	49/84 (58.3)^a	116/162 (71.6)^a
Key secondary end points
Among patients with IGA score of 0 or 1 at SOLO-CONTINUE baseline, No./total No. (%)
Patients with IGA score maintained within 1 point of baseline at week 36	18/63 (28.6)	32/64 (50.0)^c	41/66 (62.1)^a	89/126 (70.6)^a
Patients with IGA score of 0 or 1 at week 36	9/63 (14.3)	21/64 (32.8)^c	29/66 (43.9)^a	68/126 (54.0)^a
Patients with increase of ≥3 in Peak Pruritus NRS score from SOLO-CONTINUE baseline to week 35 among patients with SOLO-CONTINUE baseline score ≤7, No./total No. (%)	56/80 (70.0)	45/81 (55.6)	41/83 (49.4)^c	57/168 (33.9)^a
Other secondary end points^d
Percent change in EASI scores from SOLO-CONTINUE baseline, LS mean (SE)	−6.61 (0.80)	−1.75 (0.74)^a	−1.37 (0.74)^a	−0.09 (0.51)^a
Patients with EASI-50 at week 36 among patients with EASI-50 at SOLO-CONTINUE baseline, No./total No. (%)	33/83 (39.8)	46/84 (54.8)	52/86 (60.5)^c	124/169 (73.4)^a
Percent change in Peak Pruritus NRS score from SOLO baseline: difference between SOLO-CONTINUE baseline and week 35, LS mean (SE)	−35.6 (4.3)	−16.7 (4.1)^a	−8.6 (4.0)^a	0.1 (3.1)^a
Time to first event of IGA score ≥2 among patients with IGA score of 0 or 1 at SOLO-CONTINUE baseline
No. of patients with an event	60	52	50	85
No. of patients censored	3	12	16	41
No. of days
Mean (SD)	76.0 (62.02)	112.2 (85.98)	105.0 (89.14)	139.7 (99.95)
Median (95% CI)	57 (56-58)	85 (59-113)	80 (55-85)	114 (85-169)
Hazard ratio vs placebo (95% CI)	NA	0.63 (0.43 to 0.92)	0.71 (0.49 to 1.05)	0.45 (0.32 to 0.64)
Patients with IGA scores increased to 3 or 4 at week 36 among patients with IGA score of 0 or 1 at SOLO-CONTINUE baseline, No./total No. (%)	42/63 (66.7)	31/64 (48.4)^e	23/66 (34.8)^a	33/126 (26.2)^a
Percent change in SCORAD from SOLO baseline: difference between SOLO-CONTINUE baseline and week 36, LS mean (SE)	−28.97 (3.68)	−10.42 (2.99)^a	−2.21 (2.74)^a	−0.33 (2.09)^a
Percent BSA affected: change from SOLO-CONTINUE baseline, LS mean (SE)	−9.16 (1.64)	−2.74 (1.53)^f	−1.74 (1.46)^a	1.27 (1.04)^a
Change from SOLO-CONTINUE baseline, LS mean (SE)
POEM	−7.0 (0.90)	−2.8 (0.78)^a	−0.8 (0.73)^a	0.3 (0.56)^a
DLQI	−3.1 (0.52)	−1.5 (0.46)^c	−0.3 (0.48)^a	0.2 (0.33)^a
HADS	−0.8 (0.60)	−0.7 (0.52)	−0.2 (0.54)	0.8 (0.39)^c
Annualized event rate of flares from SOLO-CONTINUE baseline through week 36^g^,^h
Total No. of flares	62	46	38	36
Total patient-years followed	54.7	56.9	58.2	112.1
Adjusted annualized rate (95% CI)	0.75 (0.47-1.21)	0.59 (0.36-0.96)	0.44 (0.26-0.73)	0.21 (0.13-0.35)
Relative risk vs placebo (95% CI)	NA	0.78 (0.45 to 1.36)	0.58 (0.33 to 1.03)	0.28 (0.17 to 0.49)^a
Well-controlled weeks before rescue medication use, mean (SD), %ⁱ	40.9 (30.35)	53.2 (32.95)	53.3 (35.86)	63.0 (32.36)
Annualized event rate of skin infection treatment-emergent adverse events (excluding herpetic infections) through week 36
Total No. of events	10	7	1	4
Total patient-years of follow up	54.7	56.9	58.2	112.1
Adjusted annualized rate (95% CI)	0.12 (0.04-0.33)	0.09 (0.03-0.25)	0.01 (0.001-0.097)	0.02 (0.007-0.083)
Relative risk vs placebo (95% CI)	NA	0.71 (0.23-2.23)	0.10 (0.01-0.83)^c	0.20 (0.06-0.72)^c
Post hoc end points^d
Percent change in EASI score from SOLO baseline to SOLO-CONTINUE week 36, subgroups by original dose regimen in SOLO, LS mean (SE)
Originally taking dupilumab, 300 mg, every 2 wk
No.	39	39	41	80
LS mean (SE), %	−72.73 (5.68)	−82.80 (4.12)	−85.35 (4.08)	−90.75 (2.96)^j
Originally taking dupilumab, 300 mg, weekly
No.	44	45	45	89
LS mean (SE), %	−69.32 (3.38)	−87.04 (3.24)^a	−88.70 (3.00)^a	−91.88 (2.13)^a
Percent change in EASI score from SOLO baseline to SOLO-CONTINUE week 36, subgroups by SOLO-CONTINUE baseline IGA and EASI, LS mean (SE)
Subgroup with IGA score >1 at week 36, among patients with IGA score of 0 or 1 at SOLO-CONTINUE baseline
No.	53	36	32	50
LS mean (SE), %	−63.7 (8.08)	−76.1 (9.14)	−76.3 (8.12)	−79.7 (7.60)^c
Subgroup with <75% improvement in EASI score from SOLO baseline at week 36, among patients with EASI-75 at baseline
No.	34	14	19	17
LS mean (SE), %	−43.9 (4.81)	−47.4 (6.96)	−57.8 (6.39)^c	−58.6 (6.68)^c
Patients who achieved EASI-90 at week 36 among patients with EASI-90 at SOLO-CONTINUE baseline, No./total No. (%)	10/55 (18.2)	16/49 (32.7)	33/56 (58.9)^a	75/116 (64.7)^a
Percent change in Peak Pruritus NRS score from SOLO baseline to SOLO-CONTINUE week 35, subgroups by original dose regimen in SOLO (weekly or every 2 wk), LS mean (SE)
Originally taking dupilumab, 300 mg, every 2 wk
No.	39	39	41	80
LS mean (SE), %	−27.05 (7.57)	−50.93 (6.41)^c	−51.61 (6.31)^k	−60.91 (4.75)^a
Originally taking dupilumab, 300 mg, weekly
No.	44	45	45	89
LS mean (SE), %	−33.32 (7.29)	−38.68 (6.97)	−50.64 (7.14)	−59.59 (5.35)^a
Patients with improvement in Peak Pruritus NRS score from SOLO baseline to SOLO-CONTINUE week 35, No./total No. (%)
≥4 Points^l	10/78 (12.8)	21/79 (26.6)^c	27/82 (32.9)^m	78/159 (49.1)^a
≥3 Pointsⁿ	15/82 (18.3)	28/82 (34.1)^c	34/84 (40.5)^j	95/166 (57.2)^a
Patients who reported no sleep disturbance in the past 7 d at week 36 (POEM item 2), No. (%)	18 (21.7)	30 (35.7)	41 (47.7)^a	103 (60.9)^a
SCORAD Sleep Loss (scale, 0-10): change from SOLO baseline to SOLO-CONTINUE week 36, LS mean (SE)	−2.7 (0.3)	−3.3 (0.3)	−4.2 (0.2)^a	−4.3 (0.2)^a
Patients who reported no pain or discomfort, EQ-5D item, at week 36 among patients who reported moderate or severe pain or discomfort at SOLO baseline, No./total No. (%)	13/63 (20.6)	25/64 (39.1)^c	30/72 (41.7)^c	78/138 (56.5)^a

Abbreviations: DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EASI-50, proportion of patients with 50% or greater improvement in EASI from SOLO baseline; EASI-75, proportion of patients with 75% or greater improvement in EASI from SOLO baseline; EASI-90, proportion of patients with 90% or greater improvement in EASI from SOLO baseline; EQ-5D, EuroQol 5-Dimensional Scale; HADS, Hospital Anxiety and Depression Score; IGA, Investigator’s Global Assessment; SOLO-CONTINUE, Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis; LS, least squares; NA, not applicable; NRS, Numerical Rating Scale; POEM, Patient-Oriented Eczema Measure; SCORAD, Scoring Atopic Dermatitis.

^{^a}

P < .001 vs placebo.

^{^b}

P = .004 vs placebo.

^{^c}

P < .05 vs placebo.

^{^d}

P values are nominal for all endpoints other than coprimary or key secondary.

^{^e}

P = .009 vs placebo.

^{^f}

P = .002 vs placebo.

^{^g}

Safety analysis set: placebo, n = 82; dupilumab every 8 weeks, n = 84; dupilumab every 4 weeks, n = 87; dupilumab weekly or every 2 weeks, n = 167.

^{^h}

Flares were defined as worsening of disease requiring initiation or escalation of rescue treatment.

^ⁱ

Defined as the proportion of patients who responded “yes” to the question: “Has your eczema been well-controlled over the last week?” and for whom no rescue treatment was administered during that week.

^{^j}

P ≤ .003 vs placebo.

^{^k}

P = .006 vs placebo.

^{^l}

Patients with Peak Pruritus NRS scores of 4 or greater at SOLO baseline.

^{^m}

P = .005 vs placebo.

^ⁿ

Patients with Peak Pruritus NRS scores of 3 or greater at SOLO baseline.