Table of Contents
- Trial overview
- Conditions studied
- Who can participate
- Study phases and designs
- Main endpoints and outcomes
- Selected trials in more detail
- Special populations and long-term studies
Trial overview
The trial data show that Upadacitinib is being studied in many different diseases, mostly in inflammatory and immune-related conditions.[1] Most listed studies are Phase 3 trials, which usually test a treatment in larger groups and compare it with placebo or another active treatment.[1] The studies are designed to measure both how well the treatment works and how safe it is over time.[1]
Conditions studied
The trials cover a wide range of conditions, including rheumatoid arthritis, atopic dermatitis, Crohn’s disease, ulcerative colitis, systemic lupus erythematosus, hidradenitis suppurativa, alopecia areata, vitiligo, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic arthritis, giant cell arteritis, long Covid, and some muscle and skin diseases such as lichen planus and lichen planopilaris.[1]
Some trials focus on one condition only, while others study related groups together, such as psoriatic arthritis and axial spondyloarthritis, or different rheumatic diseases in people who are already taking immune-suppressing treatment.[1]
Who can participate
Who can join depends on the trial.[1] Some studies include adults only, while others include adolescents, and a few include children such as those with pediatric atopic dermatitis, pediatric ulcerative colitis, pediatric Crohn’s disease, or juvenile idiopathic arthritis.[1]
Many trials look for people with moderate to severe disease, meaning the illness is strong enough that extra treatment is needed.[1] Some studies also require people to have had an inadequate response to a previous treatment, or to be candidates for systemic therapy, which means treatment that works through the whole body rather than only on the skin or one joint area.[1]
Several rheumatoid arthritis and psoriatic arthritis studies also include people who are already in low disease activity or remission and then test whether treatment can be safely reduced without losing disease control.[1]
Study phases and designs
Most of the studies are Phase 3 trials, including large randomized studies in atopic dermatitis, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, lupus, hidradenitis suppurativa, vitiligo, and other conditions.[1] There is also a Phase 2 study in Crohn’s disease and a Phase 1 study in polyarticular course juvenile idiopathic arthritis, which focuses more on early safety and how the drug behaves in the body.[1]
Many studies are randomized, meaning participants are assigned by chance to different treatment groups.[1] Some are double-blind, which means neither the participant nor the study team knows which treatment is given during the blinded part.[1] Several studies use placebo, while others compare Upadacitinib with active treatments such as adalimumab, dupilumab, tocilizumab, vedolizumab, or corticosteroid-based regimens.[1]
Main endpoints and outcomes
The main outcomes differ by disease, but they usually measure improvement in symptoms or signs of disease.[1] In skin disease trials, common endpoints include vIGA-AD, EASI, EASI 75, EASI 90, SALT score, T-VASI, F-VASI, and HiSCR 50.[1]
In joint and autoimmune disease trials, common endpoints include ACR20, DAS28-CRP, BICLA response, minimal disease activity, and low disease activity measures such as CDAI, PASDAS, or ASDAS.[1] In bowel disease trials, outcomes include clinical remission, endoscopic response, and endoscopic remission, which are based on symptoms and camera-based examination of the bowel.[1]
Some studies also measure special outcomes, such as vaccine immune response, pharmacokinetics (how the drug moves through the body), MRI inflammation scores, pain processing in the brain, or the number of hospitalizations and surgeries over time.[1]
Selected trials in more detail
Atopic dermatitis trials are among the largest studies in the data.[1] Measure Up 1 and Measure Up 2 studied adolescents and adults with moderate to severe atopic dermatitis, while AD Up studied Upadacitinib together with topical corticosteroids, and another study examined children from 2 to less than 12 years of age compared with dupilumab.[1] These trials mainly measured skin improvement at Week 16, such as vIGA-AD 0 or 1 and EASI 75.[1]
Rheumatoid arthritis trials compared Upadacitinib with placebo and with adalimumab in adults who had not responded well to methotrexate or to a TNF inhibitor, which is a type of immune treatment.[1] The main results included ACR20, clinical remission, and DAS28-CRP, which measure joint swelling, pain, and inflammation.[1] Some rheumatoid arthritis studies also tested whether people in low disease activity could reduce JAK inhibitor treatment without losing control of the disease.[1]
Crohn’s disease and ulcerative colitis trials looked at both induction and maintenance treatment, as well as long-term extension studies.[1] The bowel disease studies measured clinical remission, endoscopic response, and long-term safety, including hospitalizations and surgeries in some studies.[1] Pediatric Crohn’s disease and pediatric ulcerative colitis studies also show that younger patients are being studied in this research program.[1]
Other important studies include systemic lupus erythematosus, hidradenitis suppurativa, alopecia areata, vitiligo, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, and juvenile idiopathic arthritis.[1] These studies use different endpoints based on the disease, such as BICLA response in lupus, HiSCR 50 in hidradenitis suppurativa, SALT score in alopecia areata, and MRI inflammation scores in axial disease.[1]
Special populations and long-term studies
Some trials focus on special groups, such as children, adolescents, or people with disease that has not improved enough with earlier treatment.[1] Others focus on long-term follow-up, including maintenance studies and long-term extension studies, where researchers continue to watch safety and disease control after the first treatment period.[1]
There is also a trial in immunosuppressed people with rheumatic diseases that looks at the immune response to the recombinant zoster vaccine, which is a vaccine against shingles.[1] This study measures antibody and T-cell responses after vaccination, showing that some Upadacitinib research is not only about disease control but also about how the immune system responds during treatment.[1]
