CROHN’S DISEASE THERAPIES EVALUATED
IN AN OPEN-LABEL ASSESSOR BLINDED HEAD-TO-HEAD TRIAL2,3
PRIMARY ENDPOINTS EVALUATED:
- Non-Inferiority Endpoint: CLINICAL REMISSION (CDAI <150) AT WEEK 24*
- Superiority Endpoint: ENDOSCOPIC REMISSION† (SES-CD ≤4) AT WEEK 48‡
*The percentage of subjects who met clinical remission at Week 24. Statistical requirement for non-inferiority achieved with ~50% of study population.
†Endoscopic remission: 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.
‡The percentage of subjects who met endoscopic remission at Week 48.
Study Design Intro: SEQUENCE was a Phase 3, multicenter, randomized, open-label, efficacy assessment-blinded§ study of SKYRIZI (n=255) compared to STELARA (ustekinumab)|| (n=265) for the treatment of adult patients with moderate to severe Crohn's disease who have failed anti-TNF therapy. Eligible patients were randomized (1:1) to receive either SKYRIZI (600 mg IV to 360 mg SC) or STELARA (weight-based¶ IV to 90 mg SC). After induction dosing was completed, patients remained on their respective therapy throughout the duration of the maintenance period (treat-through study design). No dose escalation allowed throughout the trial.
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.
§The investigator and site personnel were blinded to the results of the clinical outcomes (CDAI) and 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.
¶Baseline Stelara IV dose is weight based: ≤55 kg: 260 mg; >55 kg to 85 kg: 390 mg; or >85 kg: 520 mg.
®STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.