Abbvie submitted RINVOQ to the FDA for review to continue to benefit patients with joint problems and skin symptoms such as those caused by psoriasis.
The effectiveness of this medicine has been analyzed in phase 3 studies in which it was shown that a significant percentage of patients achieved minimal disease activity compared to placebo.
“We look forward to working with regulatory authorities and we look forward to bringing RINVOQ to people living with this debilitating disease as quickly as possible,” said Dr. Michael Severino, Vice President and President of AbbVie.
To learn about the effective results of RINVOQ, the Abbvie scientific team conducted phase 3 studies with more than 2,000 patients with active psoriatic arthritis. In both implemented studies, this novel drug met the primary endpoint of ACR20 response at week 12 compared to placebo.
The results of both investigations gave a piece of reassurance to the researchers, as it was evidenced that the patients who received RINVOQ experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75). In addition, a large percentage of the patients analyzed achieved minimal disease activity.
According to the research group, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the entire phase 3 rheumatoid arthritis clinical trial program, with no significant new safety risks being detected.1-3
A few months ago, RINVOQ received approval from the United States FDA for adult patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inappropriately or are intolerant to one or more disease-modifying antirheumatic drugs.
Now, new approval is expected to apply this drug in patients with autoimmune pathologies such as those already mentioned.
Factors to take into account
There are some side effects and recommendations that patients taking this drug should be aware of. According to Abbie, some factors to consider and to alert doctors to once treatment is prescribed are:
If you are being treated for an infection, you have an infection that does not go away or comes back, or you have symptoms of an infection such as:
- Fever, sweat, or chills
- Difficulty breathing
- Hot, red, or painful skin or sores on your body
- Muscle pains
- Feeling tired
- Blood in phlegm
- Diarrhea or stomach pain
- Burning when urinating or urinating more often than normal
- Having tuberculosis or having been in contact with someone with tuberculosis.
- Having had any type of cancer, hepatitis B or C, shingles (herpes zoster) or blood clots in the veins of the legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in the stomach or intestines.
For more information on this medication, please read the following statement: AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis