Upadacitinib (5) – Rinvoq®
Ulcerative colitis (UC), pre-treated
Characteristics
| Start date | 01.09.2022 – Marketing authorisation: 22.07.2022 |
|---|---|
| Resolution | 16.02.2023 |
| INN | Upadacitinib |
| Brand name | Rinvoq® |
| Pharm. company | AbbVie Deutschland GmbH & Co. KG |
| G-BA Procedure ID | D-848 |
| ATC code | L04AF03 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | K51.0Backwash ileitis, K51.2Ulcerative (chronic) proctitis, K51.3Ulcerative (chronic) rectosigmoiditis, K51.4Inflammatory polyps of colon, K51.5Left hemicolitis, K51.8Other ulcerative colitis, K51.9Ulcerative colitis, unspecified |
| Alpha-ID codes (AIS) | I115712Chronic ulcerative pancolitis, I115938Left-sided colitis, I26042Ulcerative colitis, I5661Chronic ulcerative proctitis, I5664Chronic rectosigmoiditis ulcerosa, I74949Colitis polyposa |
| DDD | 15 mg O |
| Therapeutic area | Digestive system diseases Ulcerative colitis / Pouchitis |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Rinvoq is used for the treatment of moderate to severe active ulcerative colitis in adult patients who have had an inadequate response, no longer respond or have not tolerated conventional therapy or a biological drug. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with moderate to severe active ulcerative colitis who have had an inadequate response, no longer respond to conventional therapy or are intolerant | A TNF-α antagonist (adalimumab or infliximab or golimumab) or vedolizumab or ustekinumab |
| b) | Adults with moderate to severe active ulcerative colitis who have had an inadequate response, no longer respond or are intolerant to a biological drug (TNF-α antagonist or integrin inhibitor or interleukin inhibitor). | A switch of therapy to vedolizumab or tofacitinib or ustekinumab or a TNF-α antagonist (adalimumab or infliximab or golimumab), in each case taking into account the labelling and previous therapy(s). |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (ACHIEVE, U-ACCOMPLISH) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + ITC (Bucher)) |
- Clinical trials
- The U-ACHIEVE and U-ACCOMPLISH studies were both double-blind RCTs comparing upadacitinib at various doses with placebo, which enrolled adult patients with moderate to severe ulcerative colitis who had not responded, or had not responded adequately, to conventional or biologic therapy, or who were intolerant to such treatments.
- The UNIFI study is a double-blind RCT comparing ustekinumab with placebo in patients with moderate to severe ulcerative colitis who did not respond, or did not respond adequately, to conventional or biologic therapy, or who were intolerant to such therapy.
a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant to it
- The additional benefit is not proven.
b) Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to it
- The additional benefit is not proven.
- Overall, therefore, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for upadacitinib compared with the appropriate comparator therapy.
- Overall assessment
- In the overall review, there is therefore no evidence of added benefit for upadacitinib compared with the appropriate comparator therapy in b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for upadacitinib compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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