2023 Meeting Magazine - 24

FOR ADULT TNFi-IR PATIENTS WITH: MODERATE TO SEVERE RHEUMATOID ARTHRITIS (RA);
ACTIVE PSORIATIC ARTHRITIS (PsA); ACTIVE ANKYLOSING SPONDYLITIS (AS); OR ACTIVE
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (nr-axSpA) WITH OBJECTIVE SIGNS
OF INFLAMMATION1
AND SHOWN TO LAST
THAT'S FAST
RApatients met ACR20 at Week 12 or 14
(Primary Endpoints) and Disease Control
through Remission (DAS28-CRP<2.6)* at
Week 12 or 14 evaluated up to 5 years.1,2
In SELECT-BEYOND:
* ACR20 at Week 12 was 65% vs 28% PBO†
(Primary Endpoint)
* Remission at Week 12 was 29% vs 10% PBO,‡
and 66% of patients were in remission at
5 yearsa
SELECT-BEYOND: 12-week, randomized, double-blind,
placebo-controlled study of 499 adult patients with
moderate to severe RA who had an inadequate response
or intolerance to bDMARDs. Patients on background
csDMARDs were randomized to receive RINVOQ 15 mg
once daily (n=164) or placebo (n=169).1,3
* Clinical remission does not mean drug-free remission
or complete absence of disease activity.
†P<0.0001 RINVOQ + csDMARD vs placebo + csDMARD.
‡NRI, P≤0.001; P value obtained through nominal
statistical testing.
aData are as observed cases (AO).
In an as observed (AO) analysis, patients with missing data at a specific time are not included, which
may enrich the population and increase the response rates.
OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias
related to overall treatment eff ect.1
PSApatients met ACR20 at Week 12
(Primary Endpoint)1,4 and Disease Control
through Minimal Disease Activity (MDA) at
Week 24 (Ranked Secondary Endpoint) and
observed up to ~3 years.1,5
In SELECT-PsA 2:
* ACR20 at Week 12 was 57% vs 24% PBO§
(Primary Endpoint, NRI)
* MDA at Week 24 was 25% vs 3% PBO§
(Ranked Secondary Endpoint, NRI), and 44%
of patients achieved MDA at ~3 yearsb
SELECT-PsA 2: 24-week, double-blind, placebo-controlled
study of 642 adult patients with moderately to severely active
PsA who had an inadequate response or intolerance to at least
1 bDMARD. Patients were randomized to receive RINVOQ 15 mg
once daily (n=211) or placebo (n=212).1,4
§P<0.001 RINVOQ vs placebo.
bData are as observed cases (AO).
As
and N R-A XsPa patients met ASAS40
at Week 14 (Primary Endpoint) and Disease
Control through ASDAS Low Disease Activity
(ASDAS LDA) at Week 14 with responses
observed at 1 year.1,6-9
In SELECT-AXIS 2:
* ASAS40 at Week 14 was 44.5% vs 18.2% PBO (AS)
and 44.9% vs 22.3% PBO||
(nr-axSpA) (Primary
Endpoint, NRI-MI)
* Low Disease Activity (LDA) at Week 14 was 44%
vs 10% PBO||
(AS) and 42% vs 18% PBO||
(nr-axSpA) (Ranked Secondary Endpoint, NRI-MI);
66% of AS patients and 70% of nr-axSpA patients
(vs 47% PBO||
) achieved LDA at 1 yearc
SELECT-AXIS 2 Study 1: 14-week, double-blind, parallel-group,
placebo-controlled phase 3 study of 420 patients with active
AS who had an intolerance or inadequate response to at least
2 NSAIDs and 1 or 2 bDMARDs. Patients were randomized to
receive RINVOQ 15 mg once daily (n=211) or placebo (n=209).
Patients could continue background NSAIDs.1,9
SELECT-AXIS 2 Study 2: 52-week, double-blind, placebocontrolled
phase 3 study of 313 patients with nr-axSpA and
1 objective sign of active inflammation based on MRI of the
sacroiliac joints and/or hs-CRP greater than the upper limit
of normal (ULN; 2.87 mg/L). Patients had an intolerance or
inadequate response to at least 2 NSAIDs and, in 33%, to
1 bDMARD. Patients were randomized to receive RINVOQ 15 mg
once daily (n=156) or placebo (n=157). Patients could continue
background NSAIDs.1,10
||P<0.0001 RINVOQ vs placebo.
cData are as observed cases (AO).
DATA LIMITATIONS: Data not labeled as a ranked secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment diff erences could represent
chance findings. No conclusions regarding these comparisons can be made.3
INDICATIONS1
RINVOQ is indicated for the treatment of:
* Moderately to severely active rheumatoid arthritis (RA) in adults who
have had an inadequate response or intolerance to one or more tumor
necrosis factor (TNF) blockers.
* Active psoriatic arthritis (PsA) in adults who have had an inadequate
response or intolerance to one or more TNF blockers.
* Active ankylosing spondylitis (AS) in adults who have had an inadequate
response or intolerance to one or more TNF blockers.
* Active non-radiographic axial spondyloarthritis (nr-axSpA) with
objective signs of inflammation in adults who have had an inadequate
response or intolerance to TNF blocker therapy.
Limitations of Use: RINVOQ is not recommended for use in combination with
other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic
drugs (bDMARDs), or with potent immunosuppressants such as azathioprine
and cyclosporine.
SAFETY CONSIDERATIONS1
SERIOUS INFECTIONS:
RINVOQ-treated patients are at increased risk of serious bacterial
(including tuberculosis [TB]), fungal, viral, and opportunistic infections
leading to hospitalization or death. Most patients who developed these
infections were taking concomitant immunosuppressants, such as
methotrexate or corticosteroids.
MORTALITY:
A higher rate of all-cause mortality, including sudden cardiovascular (CV)
death, was observed with a Janus kinase inhibitor (JAKi) in a study comparing
another JAKi with tumor necrosis factor (TNF) blockers in rheumatoid arthritis
(RA) patients ≥50 years with ≥1 CV risk factor.
MALIGNANCIES:
Malignancies have occurred in RINVOQ-treated patients. A higher rate of
lymphomas and lung cancer (in current or past smokers) was observed with
another JAKi when compared with TNF blockers in RA patients.
MAJOR ADVERSE CARDIOVASCULAR EVENTS:
A higher rate of CV death, myocardial infarction, and stroke was observed
with a JAKi in a study comparing another JAKi with TNF blockers in RA
patients ≥50 years with ≥1 CV risk factor. History of smoking increases risk.
THROMBOSIS:
Deep venous thrombosis, pulmonary embolism, and arterial thrombosis have
occurred in patients treated with JAK inhibitors used to treat inflammatory
conditions. A higher rate of thrombosis was observed with another JAKi when
compared with TNF blockers in RA patients.
HYPERSENSITIVITY:
RINVOQ is contraindicated in patients with hypersensitivity to RINVOQ or
its excipients.
OTHER SERIOUS ADVERSE REACTIONS:
Hypersensitivity Reactions, Gastrointestinal Perforations, Laboratory Abnormalities,
and Embryo-Fetal Toxicity.
ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ASAS=Assessment of SpondyloArthritis international Society;
ASAS40 = ≥40% improvement and an absolute improvement from baseline of ≥2 units on a scale of 0 to 10 in at least 3 of the 4 domains, with no worsening in the fourth domain: total back pain, inflammation (mean score
of BASDAI questions 5 and 6 on severity and duration of morning stiff ness), physical function (BASFI), and Patient Global Assessment of disease activity; ASDAS=Ankylosing Spondylitis Disease Activity Score; BASDAI=Bath
Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; csDMARD=conventional synthetic DMARD; DAS28-CRP=28 joint Disease Activity Score using C-reactive protein;
hs-CRP=high sensitivity C-reactive protein; IR=intolerance or inadequate response; MRI=magnetic resonance imaging; NRI=nonresponder imputation; NRI-MI=nonresponder imputation with multiple imputations;
NSAID=nonsteroidal anti-inflammatory drug; OLE=open-label extension; PBO=placebo; TNFi=tumor necrosis factor inhibitor.
2023 Meeting Magazine

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