Rheumatoid arthritis
Five studies involving a total of nearly 4,400 patients found Rinvoq effective in reducing symptoms in patients with moderate to severe rheumatoid arthritis. These studies involved rating disease activity in 28 joints in the body on a standard scale. They showed that Rinvoq was effective at clearing the symptoms or achieving low disease activity in 43 to 48% of patients; this compared with a reduced disease activity in 14 to 19% of patients given placebo (a dummy treatment) or methotrexate.
Psoriatic arthritis
Two studies involving over 2,000 patients with active psoriatic arthritis despite prior treatment showed that Rinvoq, used on its own or with methotrexate, was more effective than adalimumab (another medicine used for psoriatic arthritis) or placebo at reducing the symptoms of the disease. Between 57 and 71% of patients on Rinvoq at a dose of 15 mg per day achieved a reduction in symptoms after 12 weeks of treatment, compared with 65% of patients treated with adalimumab and 24 to 36% of patients on placebo.
Axial spondyloarthritis
For ankylosing spondylitis a 14-week study involving 187 patients whose disease could not be controlled well enough with other treatments showed that Rinvoq was effective at reducing symptoms of the disease. Of the patients who received Rinvoq, around 52% had a reduction in the number and severity of symptoms, compared with 26% of patients on placebo.
In addition, a study involving around 300 patients with non-radiographic axial spondyloarthritis whose diseases could not be controlled well enough with other treatments showed that Rinvoq improved symptoms of the disease: symptoms improved by at least 40% after 14 weeks in 45% of patients taking Rinvoq compared with 23% of patients on placebo.
Atopic dermatitis
Rinvoq was effective at clearing up the skin and reducing disease extent and severity in patients with moderate to severe atopic dermatitis in three main studies involving a total of 2,584 adults and children from 12 years of age. The studies compared the effects of two doses of Rinvoq (15 and 30 mg a day), used with or without corticosteroids applied to the skin, with placebo.
Treatment with Rinvoq on its own led to reduced extent and severity of the disease in 60 to 70% of patients taking the 15 mg dose and in 73 to 80% of those taking 30 mg, compared with 13 to 16% of patients given placebo. Clear or almost clear skin was achieved in 39 to 62% of patients taking Rinvoq, compared with 5 to 8% of patients on placebo.
Similar results were observed when Rinvoq was used with corticosteroids: extent and severity of the disease were reduced in 65 to 77% of patients taking Rinvoq versus 26% of patients on placebo; skin cleared or almost cleared in 40 to 59% of patients taking Rinvoq, compared with 11% of patients in the placebo group.
Ulcerative colitis
Two main studies involving 988 patients showed that Rinvoq was effective at clearing symptoms and improving the inflammation in the lining of the bowel of moderately to severely active ulcerative colitis in patients whose disease had not responded to other treatment or who could not tolerate other treatment. After eight weeks of treatment during which patients took Rinvoq 45 mg or placebo once a day, the proportion of patients on Rinvoq whose symptoms were gone or almost gone, along with normal or mild inflammation in the lining of the bowel, was 26% in the first study and 34% in the second study, compared with almost 5% and 4% for those taking placebo.
In a third study, a total of 451 patients from the first two studies whose ulcerative colitis condition had improved with Rinvoq went on to receive 15 or 30 mg of the medicine once daily, or placebo. After 52 weeks of treatment, symptoms of ulcerative colitis were gone or almost gone in 42% of patients on 15 mg Rinvoq and in 52% of patients on 30 mg Rinvoq, compared with around 12% of patients on placebo.
Crohn’s disease
Two main studies involving a total of 1,021 patients with moderately to severely active Crohn’s disease showed that Rinvoq was effective at improving symptoms of the disease. After 12 weeks of treatment during which patients took Rinvoq 45 mg or placebo once a day, the proportion of patients on Rinvoq whose symptoms were gone or almost gone in the two studies was 40% and 51%, compared with 14% and 22% for those taking placebo. Inflammation of the gut lining was reduced by more than half in 35% and 46% of patients given Rinvoq, compared with 4% and 13% in patients given placebo.
A third study involved 502 patients from the first two studies whose Crohn’s disease had improved with Rinvoq. Patients took 15 or 30 mg of the medicine once daily, or placebo. After 52 weeks of treatment, symptoms of Crohn’s disease were gone or almost gone in 36% of patients on 15 mg Rinvoq and in 46% of patients on 30 mg Rinvoq, compared with 14% of patients on placebo. Inflammation of the gut lining was reduced by more than half in 28% and 40% of patients given Rinvoq 15 mg and 30 mg, respectively, compared with 7% of patients on placebo.
