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NORTH CHICAGO, Ill., Dec. 11, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ™ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded use in two additional rheumatic indications: the treatment of adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.5 The CHMP positive opinions are based on results from three pivotal clinical studies in which RINVOQ demonstrated efficacy across multiple measures of disease activity.1-3
"The CHMP's recommendations to approve RINVOQ in both psoriatic arthritis and ankylosing spondylitis mark an important milestone. AbbVie is committed to continued research to advance treatment standards for patients living with these debilitating diseases," said Thomas Hudson, senior vice president, research and development, AbbVie. "If approved, RINVOQ will become an oral, once daily targeted treatment option across three rheumatic indications in the European Union. These recommendations pave the path towards helping more people living with psoriatic arthritis and ankylosing spondylitis find relief from their symptoms across multiple manifestations of the diseases."
In both the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 clinical trials, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.1,2
RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in SELECT-AXIS 1, a Phase 2/3 study in patients who were naïve to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).3
Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported and were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified.1-4
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization would be valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.6,7 In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.6,7
About Ankylosing Spondylitis
Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of pain, limited mobility, structural damage and vertebral fractures.8,9
About SELECT-PsA 11,10
SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg EOW or placebo at baseline. At week 24, placebo patients were switched to either RINVOQ 15 mg or RINVOQ 30 mg.
The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or RINVOQ 30 mg who achieved an ACR20 response at 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving minimal disease activity (MDA) at week 24. These are not all of the secondary endpoints. The trial is ongoing, and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.
Top-line results from SELECT-PsA 1 were previously announced in February 2020. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).
About SELECT-PsA 22,11
SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic (bDMARD). Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The trial is ongoing, and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.
Top-line results from SELECT-PsA 2 were previously announced in October 2019. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).
About SELECT-AXIS 13,12
SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active ankylosing spondylitis who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.
Key ranked secondary endpoints included proportion of subjects achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 and ASAS partial remission (PR) at week 14, as well as change from baseline in Ankylosing Spondylitis Disease Activity Scores (ASDAS), MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine) and Bath Ankylosing Spondylitis Functional Index (BASFI) at week 14. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of RINVOQ in subjects who completed Period 1.
Results from SELECT-AXIS 1 were previously announced in November 2019. More information on this trial can be found at www.clinicaltrials.gov (NCT03178487).
About RINVOQ™ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.10-20 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active 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 inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.10-12,14-20
Important Safety Information about RINVOQ™ (upadacitinib)5
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Use in combination with other potent immunosuppressants is not recommended.
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥75 years of age, caution should be used when treating this population.
Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.
The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
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