PIVOTAL TRIALSCombination Therapy
MOBILITY (MTX-IR) AND TARGET (TNF-IR) STUDY DESIGNS1,2
OPEN-LABEL EXTENSION
Combination Therapy
KEVZARA + MTX/DMARD(s) SAFETY AND EFFICACY EVALUATED OVER TIME3
- Long-term efficacy was evaluated in adult patients who completed MOBILITY or TARGET and subsequently enrolled in EXTEND Open-Label Extension (OLE)3
- Long-term safety was evaluated in all 2887 adult patients who received ≥1 dose of KEVZARA in combination with DMARD(s)3
EXTEND OLE STUDY LIMITATIONS AND ADDITIONAL STUDY CONTEXT
- These data are not included in the KEVZARA US full Prescribing Information. Data presented are truthful and not misleading
- Open-label extension studies tend to include patients who respond to treatment and exclude those who discontinue treatment for any reason. As such, evaluating long-term efficacy using continuous variables can be influenced by progressively smaller numbers of patients remaining in the study
- Data presented are descriptive in nature, and no statistical comparisons are made
- Clinical data were analyzed based on all available data as observed
LONG-TERM SAFETY ANALYSIS
- This was a comprehensive safety analysis from pooled studies of patients who received at least 1 dose of sarilumab in combination with DMARD(s)
LONG-TERM EFFICACY ANALYSIS
- Efficacy assessments in this analysis did not include all the primary endpoints from the placebo-controlled period of the pivotal trials analyzed
- For analysis of no radiographic progression, linear extrapolation was used to impute missing data. Patients with missing data after the imputation were considered progressors
Given the limitations and context described above, caution should be used in interpreting these data.
HEAD-TO-HEAD SUPERIORITY TRIAL
Monotherapy
MONARCH (MTX-IR) STUDY DESIGN7
MONARCH
A randomized, double-blind, double-dummy phase 3 superiority study to evaluate the efficacy and safety of KEVZARA monotherapy vs adalimumab monotherapy7*†
MONARCH ADDITIONAL STUDY CONTEXT
- MONARCH data are not included in the KEVZARA US full Prescribing Information
- DAS28-ESR and FACIT-Fatigue were endpoints in MONARCH; however, there are no DAS28-ESR or FACIT-Fatigue data in the KEVZARA US full Prescribing Information
USE OF ADALIMUMAB
- Adalimumab and KEVZARA have different indications and can be used differently in clinical practice
- Dose escalation from adalimumab 40 mg q2w to 40 mg qw was permitted after week 16 in patients who had not achieved at least 20% improvement in TJC and SJC. By week 24, dosing for 8.6% of patients on adalimumab was adjusted
STUDY LIMITATIONS (MONARCH)
- KEVZARA and adalimumab can be used as monotherapy or in combination with nonbiologic DMARDs. In MONARCH, both agents were only used as monotherapy
- The efficacy of KEVZARA monotherapy has not been compared to that of KEVZARA + MTX or adalimumab + MTX
- MONARCH did not evaluate radiographic outcomes in either treatment group
Given the limitations and context described above, caution should be used in interpreting monotherapy data.
MONARCH OPEN-LABEL EXTENSION
Monotherapy
MONARCH (MTX-IR) OLE STUDY DESIGN7
MONARCH OPEN-LABEL EXTENSION (OLE)
An extension designed to assess the safety and efficacy of long-term continuous KEVZARA monotherapy and switching from adalimumab monotherapy to KEVZARA monotherapy9
MONARCH OLE STUDY LIMITATIONS AND ADDITIONAL STUDY CONTEXT
- These data are not included in the KEVZARA US full Prescribing Information. Data presented are truthful and not misleading
- Long-term safety analysis included all patients who received at least 1 dose of KEVZARA monotherapy
- Analysis of clinical data was based on all available data as observed
- Data presented are descriptive in nature and no statistical comparisons are made
- Open-label extension studies tend to include patients who respond to treatment and exclude those who discontinue treatment for any reason. As such, evaluating long-term efficacy using continuous variables can be influenced by progressively smaller numbers of patients remaining in the study
Given the limitations and context described above, caution should be used in interpreting these data.