ENDOSCOPIC OUTCOMES2,3
SEQUENCE was a Phase 3, multicenter, randomized, open-label, efficacy assessment-blinded* head-to-head study comparing SKYRIZI and STELARA (ustekinumab) in adult patients with moderate to severe Crohn's disease who have failed anti-TNF therapy.
Endoscopic Response at Week 24 and Week 48 (Ranked Secondary Superiority Endpoints, NRI-MI)
DATA LIMITATION: The open-label nature of this study may have introduced bias and influenced these results.
DOSING: The lowest effective dosage for SKYRIZI should be used to maintain therapeutic response. The comparative effectiveness of SKYRIZI 180 mg is unknown, as it was not evaluated in this study.
*Endoscopies were centrally read with assessors blinded to study drug.
†Active Comparator: 31 patients received US approved ustekinumab. All other patients received European Union approved ustekinumab. The comparability between US and Non US approved ustekinumab has not been established.
®STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
ENDOSCOPIC OUTCOMES2,3
SEQUENCE was a Phase 3, multicenter, randomized, open-label, efficacy assessment-blinded* head-to-head study comparing
SKYRIZI and STELARA (ustekinumab) in adult patients with moderate to severe Crohn's disease who have failed anti-TNF therapy.
Endoscopic Remission at Week 48 (Primary Superiority Endpoint, NRI-MI)
~2x More Patients on SKYRIZI MET Endoscopic Remission vs Stelara at Week 48
PATIENTS AT BASELINE HAD AN AVERAGE DISEASE DURATION OF ~9 YEARS AND AVERAGE SES-CD SCORE OF 14
~2x More Patients on SKYRIZI MET Endoscopic Remission vs Stelara at Week 48
PATIENTS AT BASELINE HAD AN AVERAGE DISEASE DURATION OF ~9 YEARS AND AVERAGE SES-CD SCORE OF 14
Data Limitation: The open-label nature of this study may have introduced bias and influenced these results.
Endoscopic remission outcome was unavailable for 12.9% (33/255) for SKYRIZI patients and 26% (69/265) for STELARA patients.
Dosing: The lowest effective dosage for SKYRIZI should be used to maintain therapeutic response. The comparative effectiveness of SKYRIZI 180 mg is unknown, as it was not evaluated in this study.
*Endoscopies were centrally read with assessors blinded to study drug.
†Active Comparator: 31 patients received US approved ustekinumab. All other patients received European Union approved ustekinumab. The comparability between US and Non US approved ustekinumab has not been established.
®STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
ENDOSCOPIC OUTCOMES2,3
SEQUENCE was a Phase 3, multicenter, randomized, open-label, efficacy assessment-blinded* head-to-head study comparing
SKYRIZI and STELARA (ustekinumab) in adult patients with moderate to severe Crohn's disease who have failed anti-TNF therapy.
Steroid-Free Endoscopic Remission at Week 48 (Ranked Secondary Superiority Endpoint, NRI-MI)
~2x More Patients on SKYRIZI met Endoscopic Remission without Steroids (Steroid-Free Endoscopic Remission) vs STELARA at Week 48
IN THE SEQUENCE TRIAL, 71 (27%) AND 58 (23%) PATIENTS WERE TAKING CORTICOSTEROID AT BASELINE IN THE STELARA AND SKYRIZI ARMS, RESPECTIVELY.
~2x More Patients on SKYRIZI MET Endoscopic Remission without Steroids (Steroid-Free Endoscopic Remission) vs STELARA at Week 48
IN THE SEQUENCE TRIAL, 71 (27%) AND 58 (23%) PATIENTS WERE TAKING CORTICOSTEROID AT BASELINE IN THE STELARA AND SKYRIZI ARMS, RESPECTIVELY.
Data Limitation: The open-label nature of this study may have introduced bias and influenced these results.
Steroid Free Endoscopic remission outcome was unavailable for 12.9% (33/255) for SKYRIZI patients and 26% (69/265) for STELARA patients.
Dosing: The lowest effective dosage for SKYRIZI should be used to maintain therapeutic response. The comparative effectiveness of SKYRIZI 180 mg is unknown, as it was not evaluated in this study.
Steroid-free Endoscopic Remission: Total population of patients who achieved endoscopic remission, defined as SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer, who also did not receive a steroid at Week 48.
*Endoscopies were centrally read with assessors blinded to study drug.
†Active Comparator: 31 patients received US approved ustekinumab. All other patients received European Union approved ustekinumab. The comparability between US and Non US approved ustekinumab has not been established.
®STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.