AbbVie submitted a new Rinvoq adaptation application in the United States for active orthoditis.

Strong spina blinitis (AS) is a chronic, aggressive, inflammatory musculoskeletal disease that affects more than 5 million people worldwide.
symptoms of the disease can place a significant physical, psychological and financial burden on patients.
application for Rinvoq treatment of active AS adult patients is supported by data from the 2/3 SELECT-AXIS 1 Study (NCT03178487).
results showed that Rinvoq significantly improved symptoms and signs in adult patients with active AS compared to placebo, and doubled the proportion of patients who reached ASAS40 in week 14 (40 percent improvement in the Assessment of the International Society for Spinal Arthritis) (52 percent vs. 26 percent, p.001).
Severino, Vice Chairman and President of AbbVie, said:
Stabilize spina bouts (AS) is a debilitating disease that can cause severe pain, limited mobility and lasting structural damage.
with limited treatment options, innovation is critical to helping more active AS patients reach their treatment goals.
Rinvoq has the potential to improve care by helping to provide disease control, pain relief and improved function.
look forward to working with regulators and hope to bring this important treatment option to patients.
" SELECT-AXIS 1 is a multi-center, randomized, double-blind, parallel group, placebo-controlled, Phase II/III study conducted in adult patients who have never received bio-disease modified anti-rheumatoid drug therapy (bDMARD-naive) and who have inadequate responses to at least two nonsteroidal anti-inflammatory drugs (NASID) or are insatiable to NSAID/contraindications, with the aim of evaluating the safety of Rinvoq in adult patients with active AS.
The study consisted of two phases, the first of which lasted 14 weeks, with the main endpoint being the proportion of patients who reached ASAS40 remission after 14 weeks of treatment (40 per cent improvement assessed by the International Society for Spinal Arthritis), and the secondary endpoints included: the treatment of the 14th week of treatment reaching the BasDAI Activity Index (BASDAI) 50 and ASAS partial remission (PR) patient ratio, treatment week 14 strong straight spinalitis disease activity score (ASDAS), MRI Canadian Spinal Arthritis Research Association (SPARCC) score (spine), Bath strong spina bifida function index (BASFI) relative baseline changes.
phase of the study is an open label extension period to assess Rinvoq's long-term safety, tolerance and efficacy in patients who have completed phase I.
results from the first phase of the study showed that the study reached its main endpoint: in the 14th week of treatment, the proportion of patients in the Rinvoq (15 mg, once-a-day) treatment group who reached ASASAS40 (40 percent improvement in the International Spinal Arthritis Society assessment) doubled (52 percent vs. 26 percent, p.001) compared to the placebo group.
based on multiple adjustments, Rinvoq therapy showed statistically significant differences in the following indicators compared to the placebo group during week 14 of treatment: ASDAS, SPARCC MRI spine, BASDAI50, ASAS, PR BASFI.
based on nominal p-values, other endpoints are significant except WPAI.
the study, the safety of Rinvoq's treatment of AS was consistent with other previously reported therapeutic studies, including rheumatoid arthritis, adiopathic dermatitis, and psoriasis arthritis, and no new significant safety risks were found.
as is a chronic, aggressive, inflammatory disease that causes pain and stiffness mainly in the spine from early adulthood.
addition to biologics, treatment options are limited for patients who do not respond well to nonsteroidal anti-inflammatory drugs (NSAIDs) or have a precontinence.
results from the SELECT-AXIS 1 study highlighted Rinvoq's potential as an additional treatment option for AS patients.
Rinvoq's active drug ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie and is being developed to treat several immunomedulated inflammatory diseases.
JAK1 is a kinase that plays a key role in the pathophysiology of a variety of inflammatory diseases.
August 2019, Rinvoq received the world's first treatment in the United States for adult patients with moderate to severe active rheumatoid arthritis (RA) who have inadequate or insatiable response to methotrexate (MTX).
December 2019, Rinvoq was approved by the European Union to treat adult patients with moderate to severe RA who have inadequate or insatiable response to one or more disease-modified rheummatoid drugs (DMARD).
in RA, the approved dose for Rinvoq is 15 mg.
currently, Rinvoq's Phase III clinical studies for the treatment of psoriasis arthritis (PsA), RA, central axial spinal arthritis (axSpA), Crohn's disease (CD), adiopathic dermatitis (AD), ulcerative colitis (UC), and cytoarthritis (GCA) are under way.
June, AbbVie announced that it had submitted a new adaptation application for Rinvoq (upadacitinib, 15mg, once a day) in the United States and the European Union for the treatment of active PSA adult patients.
industry is very bullish on Rinvoq's business prospects.
report by Evaluate Pharma, a pharmaceutical market research organization, predicts that Rinvoq will have global sales of $2.57 billion by 2024, making it the world's fifth-best-selling anti-rheumate drug.
original origin: AbbVie Submits Regulatory application to FDA for RINVOQ™ for the Treatment of Adults with Active Ankylosing Spondylitis Original title: Anti-inflammatory new drugs! AbbVie oral JAK inhibitor Rinvoq is applying for a new adaptive disorder in Europe and the United States: the treatment of active orthosis spina blinitis (AS)!