After week 16 in MOBILITY, patients with an inadequate response could have been treated with open-label KEVZARA 200 mg every 2 weeks.1
CO-PRIMARY ENDPOINTS1-3
ACR20 response at week 24:
Patients achieved 66%* with KEVZARA 200 mg + MTX compared to 33% with placebo + MTX
ΔHAQ-DI at week 16: -0.58* with KEVZARA 200 mg + MTX compared to -0.30 with placebo + MTX
ΔmTSS from baseline at week 52: 0.25 with KEVZARA 200 mg + MTX vs 2.78 with placebo + MTX*: KEVZARA 200 mg + MTX provided an absolute difference of -2.52 units (CI: -3.38, -1.66) in mean ΔmTSS relative to placebo + MTX
CO-PRIMARY ENDPOINT DATA (TNF-IR)2-4
ACR20 response at week 24:
Patients achieved 61%* with KEVZARA 200 mg + DMARD(s) compared to 34% with placebo + DMARD(s)
ΔHAQ-DI at week 12: -0.49† with KEVZARA 200 mg + DMARD(s) compared to -0.29 with placebo + DMARD(s)
MONARCH OLE STUDY DESIGN5:
A 24-week, randomized, double-blind, double-dummy, phase 3 superiority study to evaluate the efficacy and safety of KEVZARA 200 mg q2w monotherapy (n=184) vs adalimumab 40 mg q2w monotherapy (n=185) in patients who should not continue treatment with MTX due to intolerance or inadequate response.‡§‖The primary endpoint was Δ DAS28-ESR; secondary endpoints included ΔDAS28-ESR <2.6, ACR20/50/70, ΔDAS28-CRP, ΔHAQ-DI.5
PRIMARY ENDPOINT DATA5:
- Change from baseline DAS28-ESR at 24 weeks: -3.28# with KEVZARA 200 mg q2w monotherapy compared to -2.20 with adalimumab 40 mg q2w monotherapy
- The safety profiles of KEVZARA and adalimumab were generally comparable except for neutropenia and injection site erythema for KEVZARA and headache and RA for adalimumab
MONARCH STUDY CONTEXT AND LIMITATIONS
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 LONG-TERM STUDY DESIGN
OPEN-LABEL EXTENSION (OLE) STUDY DESIGN: A 276-week (ongoing) randomized, double-blind, double-dummy phase 3 superiority study extension designed to assess the safety and efficacy of long-term continuous KEVZARA monotherapy and switching from adalimumab monotherapy to KEVZARA monotherapy in 320 adult patients who completed the MONARCH study. Primary endpoint was safety. Secondary endpoints included DAS28-ESR, DAS28-CRP, HAQ-DI, CDAI, SDAI, and ACR20/50/70.7
PRIMARY ENDPOINT DATA7
- Overall, safety observations in the OLE population were consistent with those in the MONARCH study and previous studies of KEVZARA, with no unexpected safety signals
- Long-term safety and efficacy of KEVZARA were demonstrated in patients who continued treatment with KEVZARA from MONARCH through OLE ≥72 weeks
MONARCH LONG-TERM STUDY CONTEXT AND LIMITATIONS
OLE AND ADDITIONAL STUDY CONTEXT
- These data are not included in the KEVZARA US full Prescribing Information
- 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
- OLE 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 OLE data. There are limitations associated with open-label study design, including decreasing sample size and potential continued involvement of responders and attrition of non-responders. Data presented are descriptive in nature and no statistical comparisons are made.
Please see Study Context and Limitations above for more information.