SKYRIZI 150 mg
(n=51)
HIGH IMPACT AREAS SCALP, GENITAL, PALMOPLANTAR, AND NAIL PSORIASIS
CO-PRIMARY ENDPOINTS IN UltIMMa-1 AND UltIMMa-2 (NRI)1,2
PASI 90 at Week 16
UltIMMa-1:
SKYRIZI 75% (229/304), placebo 5% (5/102)
UltIMMa-2:
SKYRIZI 75% (220/294), placebo 2% (2/98)
p<0.0001.
sPGA 0/1 at Week 16
UltIMMa-1:
SKYRIZI 88% (267/304), placebo 8% (8/102)
UltIMMa-2:
SKYRIZI 84% (246/294), placebo 5% (5/98)
NRI=Non-responder imputation.
Study Design:
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. Patients received SKYRIZI 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,2
In UnllMMited (Study-S), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe scalp psoriasis3
SKYRIZI EFFICACY IN SCALP PSORIASIS3
61% OF PATIENTS TREATED WITH SKYRIZI ACHIEVED COMPLETELY CLEAR OR ALMOST CLEAR SKIN ON THEIR SCALP AT WEEK 163
PERCENTAGE OF PATIENTS ACHIEVING SCALP IGA O/1 AT WEEK 16 (NRI)
The scalp IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation.
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-S had PSSI ≥12, scalp IGA ≥3, and ≥30% of scalp affected at baseline.3
BSA=body surface area; NRI=nonresponder imputation; PSSI=Psoriasis Scalp Severity Index; scalp IGA=scalp Investigator's Global Assessment; sPGA=static Physician's Global Assessment.
In UnllMMited (Study-S), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe scalp psoriasis3
SKYRIZI EFFICACY IN SCALP PSORIASIS3
EFFICACY IN PSORIASIS SCALP SEVERITY INDEX (PSSI) AT WEEK 163
PERCENTAGE OF PATIENTS ACHIEVING PSSI AT WEEK 16 (NRI)
p>0.0001
The composite PSSI score is calculated as the sum of the scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of scalp area involved. The PSSI ranges from 0 to 72.
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-S had PSSI ≥12, scalp IGA ≥3, and ≥30% of scalp affected at baseline.3
BSA=body surface area; NRI=nonresponder imputation; PSSI=Psoriasis Scalp Severity Index; scalp IGA=scalp Investigator's Global Assessment; sPGA=static Physician's Global Assessment.
In UnllMMited (Study-S), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe scalp psoriasis3
SKYRIZI EFFICACY IN SCALP PSORIASIS3
50% OF PATIENTS TREATED WITH SKYRIZI REPORTED A 4-POINT OR GREATER REDUCTION OF SCALP PSORIASIS ITCH AT WEEK 167
PERCENTAGE OF PATIENTS ACHIEVING ≥4-POINT IMPROVEMENT AT WEEK 16 (NRI)
LIMITATIONS:
Achievement of ≥4-point improvement (reduction) from baseline on the Scalp Ps-Itch NRS among subjects with a baseline score ≥4 was a prespecified, nonranked endpoint and not controlled for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
The Scalp Psoriasis Itch Numerical Rating Scale (Scalp Ps-ltch NRS) is a patient-reported instrument that assesses itch on a scale of 0 (no itch) to 10 (worst imaginable itch).
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-S had PSSI ≥12, scalp IGA ≥3, and ≥30% of scalp affected at baseline.3
BSA=body surface area; NRI=nonresponder imputation; PSSI=Psoriasis Scalp Severity Index; scalp IGA=scalp Investigator's Global Assessment; Scalp Ps-Itch NRS=Scalp Psoriasis Itch Numerical Rating Scale; sPGA=static Physician's Global Assessment.
In UnllMMited (Study-S), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe scalp psoriasis3
SKYRIZI EFFICACY IN SCALP PSORIASIS3
47% OF PATIENTS TREATED WITH SKYRIZI Reported DLQI OF 0 OR 1 At Week 167
PROPORTION OF PATIENTS REPORTING DLQI 0/1 AT WEEK 16 (NRI)
LIMITATIONS:
DLQI of 0 or 1 was a prespecified, nonranked endpoint and not controlled for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
Dermatology Life Quality Index (DLQI) is a 10-question, self-administered questionnaire that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships including sexual difficulties, and treatment). Each question is scored from 0-3 depending on impact of life (0=no impact on quality of life and 3=maximum impact on quality of life) with a total combined score 0-30.
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-S had PSSI ≥12, scalp IGA ≥3, and ≥30% of scalp affected at baseline.3
BSA=body surface area; DLQI=Dermatology Life Quality Index; NRI=nonresponder imputation; PSSI=Psoriasis Scalp Severity Index; scalp IGA=scalp Investigator's Global Assessment; SD=standard deviation; sPGA=static Physician's Global Assessment.
In UnllMMited (Study-G), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe genital psoriasis3
SKYRIZI EFFICACY IN GENITAL PSORIASIS3
69% OF PATIENTS TREATED WITH SKYRIZI ACHIEVED COMPLETELY CLEAR OR ALMOST CLEAR SKIN IN THE GENITAL AREA AT WEEK 163
PERCENTAGE OF PATIENTS ACHIEVING sPGA-G* O/1 AT WEEK 16 (NRI)
The sPGA-G is a 6-point scale based on the extent of erythema, plaque elevation, and/or scale. It ranges from 0 (clear) to 5 (very severe).
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-G had moderate to severe genital psoriasis (sPGA-G ≥3).3
BSA=body surface area; NRI=nonresponder imputation; sPGA=static Physician's Global Assessment; *sPGA-G=static Physician's Global Assessment of Genitalia.
In UnllMMited (Study-G), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe genital psoriasis3
SKYRIZI EFFICACY IN GENITAL PSORIASIS3
51% OF PATIENTS TREATED WITH SKYRIZI ACHIEVED COMPLETE CLEARANCE OF THEIR GENITAL PSORIASIS AT WEEK 163
PERCENTAGE OF PATIENTS ACHIEVING sPGA-G* 0 AT WEEK 16 (NRI)
p<0.0001
SKYRIZI 150 mg
(n=55)
The sPGA-G is a 6-point scale ranging from 0 to 5. The final sPGA-G score should be based on a combination of erythema and the secondary features (plaque elevation and/or scale).
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-G had moderate to severe genital psoriasis (sPGA-G ≥3).3
BSA=body surface area; NRI=nonresponder imputation; sPGA=static Physician's Global Assessment; *sPGA-G=static Physician's Global Assessment of Genitalia.
In UnllMMited (Study-G), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe genital psoriasis3
SKYRIZI EFFICACY IN GENITAL PSORIASIS3
49% OF PATIENTS ACHIEVED A CLINICALLY MEANINGFUL IMPROVEMENT (≥4-POINT) FROM BASELINE IN GENITAL PSORIASIS ITCH AT WEEK 163
PERCENTAGE OF PATIENTS ACHIEVING ≥4-POINT IMPROVEMENT AT WEEK 16 (NRI)
p<0.0001
The Genital Psoriasis Itch Numerical Rating Scale (GenPs-Itch NRS) is a patient-reported instrument that assesses itch on a scale of 0 (no itch) to 10 (worst imaginable itch).
ITCH NRS AT BASELINE (SD)
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-G had moderate to severe genital psoriasis (sPGA-G ≥3).3
BSA=body surface area; GenPs-Itch NRS=Genital Psoriasis Itch Numerical Rating Scale; NRI=nonresponder imputation; SD=standard deviation; sPGA=static Physician's Global Assessment; sPGA-G=static Physician's Global Assessment of Genitalia.
In UnllMMited (Study-G), a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study evaluating SKYRIZI in patients with moderate to severe genital psoriasis3
SKYRIZI EFFICACY IN GENITAL PSORIASIS3
60% OF PATIENTS TREATED WITH SKYRIZI ACHIEVED DLQI 0/1 AT WEEK 163
PERCENTAGE OF PATIENTS ACHIEVING DLQI 0/1 AT WEEK 16 (NRI)
p<0.0001
SKYRIZI 150 mg
(n=55)
Dermatology Life Quality Index (DLQI) is a 10-question, self-administered questionnaire that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships including sexual difficulties, and treatment). Each question is scored from 0-3 depending on impact of life (0=no impact on quality of life and 3=maximum impact on quality of life) with a total combined score 0-30.
STUDY DESIGN:
UnlIMMited is a Phase 4, multicenter, randomized, double-blind, placebo-controlled basket study examining the effect of SKYRIZI (150 mg) vs placebo for moderate to severe genital psoriasis (Study-G) or scalp psoriasis (Study-S). Eligible patients were randomized in a ratio of 1:1 to receive SKYRIZI or placebo. In both Study-S and Study-G, baseline criteria included patients eligible for systemic therapy, sPGA of moderate to severe (≥3), and BSA ≥1% (at least 60% of patients within each study had a baseline BSA ≥10%). Patients included in Study-G had moderate to severe genital psoriasis (sPGA-G ≥3).3
BSA=body surface area; DLQI=Dermatology Life Quality Index; NRI=nonresponder imputation; SD=standard deviation; sPGA=static Physician's Global Assessment; sPGA-G=static Physician's Global Assessment of Genitalia.
IMMprint, a randomized, double-blind, placebo-controlled, Phase 3b study evaluating SKYRIZI in moderate to severe Ps patients with palmoplantar involvement4
SKYRIZI EFFICACY IN PALMOPLANTAR PSORIASIS4
SKYRIZI MET THE PRIMARY ENDPOINT OF ppIGA 0/1 AT WEEK 16 WITH RESPONSE RATES OBSERVED AT WEEK 524
PROPORTION OF PATIENTS ACHIEVING ppIGA 0/1 AT WEEK 16 WITH RESPONSES OBSERVED AT WEEK 52 (NRI-C)
LIMITATIONS:
All endpoints at Week 52 were prespecified, nonranked endpoints and were not controlled for multiple comparisons. Therefore, no statistical or clinical conclusions can be drawn.
Open-Label LIMITATIONS:
In an open-label study or period, there is potential for enrichment; awareness of active treatment may cause bias to overall treatment effect.
The ppIGA scale ranges from clear (0) to severe (4) and is based on the modified IGA but specifically applied to the palms and soles.
STUDY DESIGN:
IMMprint was a Phase 3b, multicenter, randomized, double-blind, parallel-group, placebo-controlled, 52-week study that assessed the safety and efficacy of SKYRIZI (150 mg) vs placebo for the treatment of moderate to severe plaque psoriasis in patients with palmoplantar (non-pustular) involvement. The primary endpoint evaluated the proportion achieving ppIGA of 0 or 1 with ≥2-point reduction from baseline at Week 16. Additional ranked secondary endpoints included PPASI 75, PPASI 90, sPGA 0/1, and PPASI 100 at Week 16.4
IGA=Investigator's Global Assessment; NRI-C=nonresponder imputation incorporating multiple imputations to handle missing data due to COVID-19; PPASI=Palmoplantar Psoriasis Area and Severity Index; ppIGA=Palmoplantar Psoriasis Investigator's Global Assessment; RCT=randomized controlled trial; sPGA=static Physician's Global Assessment.
EFFICACY IN PALMOPLANTAR PSORIASIS4
*Ranked secondary endpoint.
MEAN CHANGE IN PPASI FROM BASELINE (AO)6
AT WEEK 16
PLACEBO 30% (N=81)
MEAN PPASI SCORES AT BASELINE (SD)
SKYRIZI (n=87)
22.5 (13.6)
PLACEBO (n=87)
22.5 (12.1)
LIMITATIONS:
PPASI 75 at Week 52, PPASI 90 at Week 52, and mean change in PPASI were nonranked endpoints and not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
OPEN-LABEL (OL) LIMITATIONS:
In an open-label study or period, there is potential for enrichment; awareness of active treatment may cause bias to overall treatment effect.
AO DISCLOSURE:
In an as observed analysis (AO) missing visit data was excluded from calculations for that visit, which may increase the percent of responders. All observed data was used regardless of premature discontinuation of study drug, initiation of concomitant medication, or rescue medication. The same patient may not have a response at each timepoint.
STUDY DESIGN:
IMMprint was a Phase 3b, multicenter, randomized, double-blind, parallel-group, placebo-controlled, 52-week study that assessed the safety and efficacy of SKYRIZI (150 mg) vs placebo for the treatment of moderate to severe plaque psoriasis in patients with palmoplantar (non-pustular) involvement. The primary endpoint evaluated the proportion achieving ppIGA of 0 or 1 with ≥2-point reduction from baseline at Week 16. Additional ranked secondary endpoints included PPASI 75, PPASI 90, sPGA 0/1, and PPASI 100 at Week 16.4
AO=as observed; NRI-C=nonresponder imputation incorporating multiple imputations to handle missing data due to COVID-19; OL=open-label; PPASI=Palmoplantar Psoriasis Area and Severity Index; ppIGA=Palmoplantar Psoriasis Investigator's Global Assessment; SD=standard deviation; sPGA=static Physician's Global Assessment.
SEE ADDITIONAL Ps DATA IN HIGH IMPACT AREAS
FROM A SUBGROUP ANALYSIS OF UltlMMa-1 AND UltlMMa-2 BELOW
In a subgroup analysis of UltlMMa-1 and UltlMMa-2
ON AVERAGE, PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS EXPERIENCED MEAN IMPROVEMENT IN HIGH IMPACT AREAS: SCALP, PALMOPLANTAR, AND NAIL PSORIASIS5
IN AN INTEGRATED SUBANALYSIS OF UltIMMa-1 AND UltIMMa-2 PATIENTS AT WEEK 52 (LOCF)5
94%
MEAN IMPROVEMENT
IN SCALP PSORIASIS
(MEAN CHANGE IN PSSI FROM BASELINE)
n=528
66%
MEAN IMPROVEMENT IN
NAIL PSORIASIS
(MEAN CHANGE IN NAPSI FROM BASELINE)
n=361
91% MEAN IMPROVEMENT IN PALMOPLANTAR PSORIASIS
(MEAN CHANGE IN PPASI FROM BASELINE) n=184
MEAN PATIENT SCORES AT BASELINE (SD)
PSSI
18.2 (14.7)
PPASI
2.42 (6.0)
NAPSI
13.6 (18.4)
LIMITATIONS:
Mean change in PSSI, PPASI, and NAPSI were prespecified, nonranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
Based on analysis of integrated data from UltIMMa-1 and UltIMMa-2 at Week 52 of patients receiving SKYRIZI who had a baseline score of >0 on NAPSI, PSSI, and PPASI, respectively. Missing NAPSI, PSSI, and PPASI data were imputed as last observation carried forward (LOCF).5
STUDY DESIGN:
UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,2
LOCF=last observation carried forward; NAPSI=Nail Psoriasis Severity Index; PPASI=Palmoplantar Psoriasis Area and Severity Index; PSSI=Psoriasis Scalp Severity Index; SD=standard deviation.
4 DOSES PER YEAR
3-month dosing after 2 initiation doses at
Weeks 0 and 4 (150 mg/dose)1
