Patients with moderately to severely active UC* with inadequate response, loss of response, or intolerance to:
aminosalicylates, immunosuppressants, corticosteroids and/or biologics
*Defined as adapted Mayo score 5–9 with centrally assessed endoscopic subscore of 2–3.
†Randomisation stratified by history of biologic failure (IR, loss of response or intolerance [yes vs no]), baseline corticosteroid use (yes vs no) and baseline adapted Mayo Score (≤7 vs >7).
‡Defined as aMs decrease ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from Baseline or an absolute RBS ≤1.
§Randomisation stratified by previous biologic failure, induction clinical remission status and corticosteroid use at the beginning of U-ACHIEVE Maintenance. Primary efficacy analysis = first 450 [planned] clinical responders to 8-week RINVOQ 45 mg induction.
||For subjects taking corticosteroid therapy at baseline of induction studies (~40%). At Week 0 of the maintenance study (Week 16 of the open-label extension), corticosteroid therapy was tapered according to a predefined schedule.
¶Patients who did not achieve clinical response at Week 8 in U-ACHIEVE and U-ACCOMPLISH continued in an additional 8-week, open-label, induction extension period with RINVOQ 45 mg QD. Patients who received 8 weeks total RINVOQ 45 mg QD with response at Week 16 were re-randomised into the maintenance study 1:1:1 to placebo RINVOQ 15 mg or RINVOQ 30 mg.
**Patients who received RINVOQ 45 mg QD for 16 weeks who had a response at Week 16 were randomised to RINVOQ 15 or 30 mg QD maintenance but were not included in the primary analysis. Patients who did not achieve clinical response by Week 16 of induction were discontinued.
#Patients analysed entered the LTE study in clinical remission (adapted Mayo Score (aMs) 5–9 with centrally assessed endoscopic subscore of 2–3) at Week 0 of the LTE study/Week 52 of maintenance and continued the same dose of RINVOQ. Patients not in remission at Week 52 of maintenance (U-ACHIEVE) underwent dose escalation and were not analysed. Patients who underwent dose escalation or de-escalation at Week 48 of the LTE study were also excluded from this LTE analysis.
*Methotrexate
†The maximum dose of corticosteroid allowed as concomitant therapy was 30 mg prednisone equivalent.
*Methotrexate
†The maximum dose of corticosteroid allowed as concomitant therapy was 30 mg prednisone equivalent.
16 to 75 yearsa with a diagnosis of active UC for ≥90 days prior to baseline,b with an aMs of 5 to 9 points and ESS of 2 to 3
Inadequate response to, loss of response to, or intolerance to at least one of the following treatments including oral aminosalicylates, corticosteroids, immunosuppressants and/or biologic therapiesc
Diagnosis of Crohn’s disease, indeterminate colitis, fulminant colitis, toxic megacolon
Disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery.
Active infection
Prior exposure to systemic JAK inhibitors
aBody weight ≥40 kg at BL for subjects 16 and 17 years. bConfirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. cAn inadequate response, loss of response, or intolerance to oral aminosalicylates did not count towards eligibility in Austria, Czechia, Finland, France, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Spain, Sweden, and the United Kingdom.
These are key inclusion/exclusion criteria. Refer to supplement in paper for the full list.2
Endpoints are as per the product information1
*Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopy activity will confer an endoscopic subscore of 2.
aMs, adapted Mayo score; BL, baseline; ESS, endoscopic subscore; LTE, long-term extension; PGA, Physician Global Assessment; QD, once-daily; RBS, rectal bleeding score; SD, standard deviation; SFS, stool frequency score; UC, ulcerative colitis.
REFERENCES
- RINVOQ Product Information.
- Danese S et al. Lancet 2022;399(10341):2113–28.
- Panaccione R et al. UEG Journal 2023;11(8):141–2.
WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients: Refer to Product Information. |
PBS Information
RINVOQ: Authority required. Refer to PBS Schedule for full authority information.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-220270. May 2024