| CUPID-A1,2 | CUPID-C1,2 | |||
|---|---|---|---|---|
|
CUPID-A and CUPID-C
assessed the efficacy of DUPIXENT on itch relief and hive reduction at Week 24.1,2 |
DUPIXENT (n=68) |
Placebo (n=68) |
DUPIXENT (n=73) |
Placebo (n=75) |
| Primary endpoint | ||||
| Reduction from baseline in itch severity score over 7 days (ISS7) |
64% -10.44 (P=0.0003) |
35% -6.02 |
48% -8.50 (P=0.0270) |
33% -6.13 |
| Mean at baseline | 16.25 | 15.74 | 15.18 | 14.96 |
| Key secondary endpoint | ||||
| Reduction from baseline in urticaria activity score over 7 days (UAS7) |
66% -20.99 (P=0.0001) |
36% -11.95 |
48% -15.61 (P=0.0324) |
32% -11.27 |
| Mean at baseline | 32.10 | 30.76 | 28.48 | 27.86 |
| Other secondary endpoints | ||||
| Reduction from baseline in hives severity score over 7 days (HSS7) |
68% -10.54 (P=0.0001) |
36% -5.85 |
46% -7.16 (P=0.0450) |
31% -5.15 |
| Mean at baseline | 15.85 | 15.03 | 13.31 | 12.90 |
| Proportion of patients with complete response (UAS7=0) |
32% (P=0.0133) |
13% | 30% (P=0.0165) |
17% |
| Proportion of patients with well-controlled symptoms (UAS7 ≤6) |
47% (P=0.0034) |
24% | 40% (P=0.0062) |
23% |
CUPID-A and CUPID-C assessed the
efficacy of DUPIXENT on itch relief
and hive reduction at Week 24.1,2
| CUPID-A1,2 | |
|---|---|
| DUPIXENT (n=68) |
Placebo (n=68) |
| Primary endpoint | |
| Reduction from baseline in itch severity score over 7 days (ISS7) |
|
| 64% -10.44 (P=0.0003) |
35% -6.02 |
| Mean at baseline | |
| 16.25 | 15.74 |
| Key secondary endpoint | |
| Reduction from baseline in urticaria activity score over 7 days (UAS7) |
|
| 66% -20.99 (P=0.0001) |
36% -11.95 |
| Mean at baseline | |
| 32.10 | 30.76 |
| Other secondary endpoints | |
| Reduction from baseline in hives severity score over 7 days (HSS7) |
|
| 68% -10.54 (P=0.0001) |
36% -5.85 |
| Mean at baseline | |
| 15.85 | 15.03 |
| Proportion of patients with complete response (UAS7=0) |
|
| 32% (P=0.0133) |
13% |
| Proportion of patients with well-controlled symptoms (UAS7 ≤6) |
|
| 47% (P=0.0034) |
24% |
| CUPID-C1,2 | |
|---|---|
| DUPIXENT (n=73) |
Placebo (n=75) |
| Primary endpoint | |
| Reduction from baseline in itch severity score over 7 days (ISS7) |
|
| 48% -8.50 (P=0.0270) |
33% -6.13 |
| Mean at baseline | |
| 15.18 | 14.96 |
| Key secondary endpoint | |
| Reduction from baseline in urticaria activity score over 7 days (UAS7) |
|
| 48% -15.61 (P=0.0324) |
32% -11.27 |
| Mean at baseline | |
| 28.48 | 27.86 |
| Other secondary endpoints | |
| Reduction from baseline in hives severity score over 7 days (HSS7) |
|
| 46% -7.16 (P=0.0450) |
31% -5.15 |
| Mean at baseline | |
| 13.31 | 12.90 |
| Proportion of patients with complete response (UAS7=0) |
|
| 30% (P=0.0165) |
17% |
| Proportion of patients with well-controlled symptoms (UAS7 ≤6) |
|
| 40% (P=0.0062) |
23% |
aBiologic-naive defined as no anti-IgE treatment.
See the efficacy across key measures
CUPID-A and CUPID-C assessed the efficacy of DUPIXENT for itch relief (ISS7), hive reduction (HSS7), and urticaria activity score over 7 days (UAS7) at Week 24.
The severity of itch is measured by a patient-reported itch severity score (ISS, ranging from 0 = none to 3 = intense). The ISS7 score is the sum of daily ISS scores measured by a patient at the same time each day over 7 days, with an overall scale of 0 to 212:
The severity of hives is measured by a patient-reported hives severity score (HSS, ranging from 0 = none to 3 = more than 50 hives). The HSS7 score is the sum of daily HSS scores measured by a patient at the same time each day over 7 days, with an overall scale of 0 to 212:
Urticaria activity score (UAS) is a composite patient-reported outcome measure, which is the sum of the daily itch severity score (ISS, ranging from 0 = none to 3 = intense) and daily hive severity score (HSS, ranging from 0 = none to 3 = more than 50 hives). UAS7 is the sum of the preceding 7 days’ itch and hives scores, for a total UAS7 range of 0 to 42. Urticaria disease activity is classified in 5 severity categories2:
ISS7
+
HSS7
=
UAS7
DEMONSTRATED SAFETY PROFILE
| ADVERSE REACTIONS OCCURRING IN ≥2% OF PATIENTS THROUGH WEEK 241 POOLED ACROSS CUPID STUDIES A, B, AND Cb |
||
|---|---|---|
| ADVERSE REACTION | DUPIXENT 200/300 mg Q2W (n=195) % |
Placebo (n=197) % |
| Injection site reactionc | 10 | 8 |
| Rate of treatment discontinuation at Week 241,b | ||
| Rate of discontinuations due to adverse events vs placebo | ||
1.0%
DUPIXENT
2.5%
PLACEBO
- Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment1
Q2W, every 2 weeks.
bPooled safety population from CUPID-A, CUPID-B, and CUPID-C. CUPID-B was an identically designed study that enrolled 108 CSU patients (aged 12 years or older) who were inadequate responders (N=104) to H1 antihistamines and anti-IgE treatments or intolerant (N=4) to anti-IgE therapy. The efficacy of DUPIXENT was based only on CUPID-A and CUPID-C; CUPID-B did not meet the primary endpoint.
cInjection site reactions cluster includes injection site dermatitis, injection site erythema, injection site hematoma, injection site induration, injection site pain, injection site pruritus, injection site reaction, and injection site swelling.
DOSAGE AND ADMINISTRATION
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