DURABLE
REMISSION
WITH OR WITHOUT MTX2-4
RINVOQ achieved DAS28-CRP <2.6* and DAS28-CRP ≤3.2 (ranked secondary endpoints) at Week 12 or 14, with durable remission and low disease activity rates out to ~5 years.1-6
*Does not mean drug-free remission or complete absence of disease activity.
INDICATION
RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
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.
NRI Data From SELECT-BEYOND (bDMARD-IR)1,5
RINVOQ 15 mg + csDMARD (n=164), placebo + csDMARD (n=169)
ACR20
65%* vs 28% placebo at Week 12
PRIMARY ENDPOINT
*P<0.0001 RINVOQ vs placebo.
SELECT-BEYOND (Study RA-V)1,5:
24‑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). The primary endpoint was ACR20 response at Week 12.
NRI Data From SELECT-MONOTHERAPY (MTX-IR)1,2
RINVOQ 15 mg (n=217), cMTX (n=216)
ACR20
68%* vs 41% MTX at Week 14
PRIMARY ENDPOINT
*P<0.0001 RINVOQ vs MTX.
RINVOQ IS INDICATED FOR TNFi-IR PATIENTS.
SELECT-MONOTHERAPY (Study RA-II)1,2:
14‑week, randomized, double‑blind, active comparator‑controlled study of 648 adult patients with moderate to severe RA who had an inadequate response to MTX. The primary endpoint was ACR20 response at Week 14.
CRP=C-reactive protein; DAS28-CRP=28 joint disease activity score using C-reactive protein; DMARD=disease-modifying antirheumatic drug; IR=intolerance or inadequate response; JAK=Janus kinase; LDA=low disease activity; MTX=methotrexate; TNF=tumor necrosis factor; TNFi=tumor necrosis factor inhibitor.
Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis, below.
Remission & LDA Rates With or Without MTX at Weeks 12 and 141-3,7
REMISSION:
(DAS28-CRP <2.6*)
RINVOQ is indicated for TNFi-IR patients.
†P≤0.001 for RINVOQ + csDMARDs vs placebo + csDMARDs; analysis was not controlled for multiplicity. P-value obtained through nominal statistical testing.
*Clinical remission does not mean drug-free remission or complete absence of disease activity.
DATA LIMITATIONS:
Data not labeled as a ranked secondary endpoint were prespecified non-ranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
LDA:
(DAS28-CRP ≤3.2)
RINVOQ is indicated for TNFi-IR patients.
Durable Remission Rates With or Without MTX Out to ~5 Years4,5,8,9
SELECT-BEYOND:
bDMARD-IR Patients
ALL DATA AS OBSERVED (AO)
DAS28-CRP <2.6*
66% of RINVOQ + csDMARDs patients achieved clinical remission at Week 260
RINVOQ is indicated for TNFi-IR patients.
Starting at Week 24, initiation of or change in corticosteroids, NSAIDs, acetaminophen, and csDMARDs was permitted. Patients not achieving response criteria ≥20% improvement in SJC and TJC at two consecutive visits were removed from the study.
*Clinical remission does not mean drug-free remission or complete absence of disease activity.
SELECT-MONOTHERAPY:
MTX-IR Patients
ALL DATA AS OBSERVED (AO)
DAS28-CRP <2.6*
71% of RINVOQ patients achieved clinical remission at Week 260
RINVOQ is indicated for TNFi-IR patients.
Treatment groups were by initial randomization. Starting at Week 26, initiation of or change in corticosteroids, NSAIDs, acetaminophen or ≤2 csDMARD was allowed for patients who did not achieve CDAI ≤10.
*Clinical remission does not mean drug-free remission or complete absence of disease activity.
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.
LTE LIMITATIONS: There is potential for enrichment of LTE data; unblinding patients may cause bias related to overall treatment effect.
Safety Considerations
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.
Durable Low Disease Activity Rates With or Without MTX out to ~5 Years4,5,8
SELECT-BEYOND:
bDMARD-IR Patients
ALL DATA AS OBSERVED (AO)
LDA (DAS28-CRP ≤3.2)
81% of RINVOQ + csDMARDs patients achieved LDA at Week 260
RINVOQ is indicated for TNFi-IR patients.
Starting at Week 24, initiation of or change in corticosteroids, NSAIDs, acetaminophen, and csDMARDs was permitted. Patients not achieving response criteria ≥20% improvement in SJC and TJC at two consecutive visits were removed from the study.
SELECT-MONOTHERAPY:
MTX-IR Patients
ALL DATA AS OBSERVED (AO)
LDA (DAS28-CRP ≤3.2)
89% of RINVOQ patients achieved LDA at Week 260
RINVOQ is indicated for TNFi-IR patients.
Treatment groups were by initial randomization. Starting at Week 26, initiation of or change in corticosteroids, NSAIDs, acetaminophen or ≤2 csDMARD was allowed for patients who did not achieve CDAI ≤10.10
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.
LTE LIMITATIONS: There is potential for enrichment of LTE data; unblinding patients may cause bias related to overall treatment effect.
Interested in the safety data for RINVOQ?
See RINVOQ’s safety data across clinical trials
