Guideline: 2021 ACR RA
Clinical question: Should patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity receive MTX monotherapy or boDMARD with MTX or tsDMARD with MTX?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor + MTX
Abatacept+ MTX
Rituximab+ MTX
IL-6 Receptor Inhibitor+ MTX
JAK Inhibitor + MTX
Outcomes:
TNF Inhibitor + MTX: Disease activity (follow up: range 6 months to 1 year; assessed with: ACR 20)
Disease activity (follow up: 6 months; assessed with: ACR 50)
Disease activity (follow up: range 6 months to 12 months; assessed with: ACR 70)
Disease activity (follow up: range 6 months to 12 months; assessed with: DAS28 or DAS44 (Lower values -> benefit) (values>0.2 are considered clinically important)
Remission (follow up: range 6 months to 12 months; assessed with: DAS28<2.6)
Radiographic progression (follow up: 1 year; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Fatigue (follow up: 1 year; assessed with: VAS fatigue (Lower values – > benefit) (MCID -1.12 to -0.82))
Pain (follow up: 1 year; assessed with: VAS pain (Lower values – > benefit) (MCID -11.9)
Disability (follow up: range 6 months to 12 months; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Quality of Life (follow up: range 6 months to 12 months; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4)
Quality of Life (follow up: range 6 months to 12 months; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1)
Withdrawal due to lack of efficacy (follow up: range 6 months to 12 months)
Withdrawal due to adverse events (follow up: range 6 months to 12 months)
Serious adverse events (follow up: range 6 months to 12 months)
Death (follow up: range 6 months to 12 months)
Malignancy (from SRs on harms)
Abatacept + MTX: Disease activity (follow up: 1 year; assessed with: ACR 70)
Disease activity (follow up: 1 year; assessed with: DAS28 CRP (Lower values – > benefit) (MCID -1.02))
Remission (follow up: 1 year; assessed with: DAS28-ESR remission <2.6)
Radiographic progression (follow up: 1 year; assessed with: mTSS (Lower values – > benefit) (MCID 4.6))
Disability (follow up: 1 year; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22))
Quality of Life (follow up: 1 year; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4))
Quality of Life (follow up: 1 year; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1))
Withdrawal due to lack of efficacy (follow up: 1 year)
Withdrawal due to adverse events (follow up: 1 year)
Serious adverse events (follow up: 1 year)
Malignancy (follow up: 1 year)
Death (follow up: 1 year)
Malignancy (from SRs on harms)
Rituximab + MTX: Disease activity (follow up: 2 years; assessed with: ACR 20)
Disease activity (follow up: 2 years; assessed with: ACR 50)
Disease activity (follow up: 2 years; assessed with: ACR 70)
Disease activity (follow up: 2 years; assessed with: DAS28 ESR (Lower values – > benefit) (MCID -1.17)
Remission (follow up: 2 years; assessed with: DAS28-ESR remission <2.6)
Radiographic progression (follow up: 2 years; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Pain (follow up: 1 year; assessed with: VAS pain (Lower values – > benefit) (MCID -11.9)
Fatigue (follow up: 1 year; assessed with: FACIT-F (Higher values – > benefit) (MCID 15.9)
Disability (follow up: 2 years; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Quality of Life (follow up: 1 year; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4)
Quality of Life (follow up: 1 year; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1)
Withdrawal due to adverse events (follow up: 2 years)
Serious adverse events (follow up: 2 years)
Malignancy (follow up: 2 years)
Death (follow up: 2 years)
Malignancy (from SRs on harms)
IL-6 Receptor Inhibitor + MTX: Disease activity (follow up: 1 year; assessed with: ACR 20)
Disease activity (follow up: 1 year; assessed with: ACR 50)
Disease activity (follow up: 1 year; assessed with: ACR 70)
Disease activity (follow up: 1 year; assessed with: DAS28-ESR (Lower values – > benefit) (MCID -1.17))
Remission (follow up: 1 year; assessed with: DAS28-ESR remission <2.6)
Radiographic progression (follow up: 1 year; assessed with: mTSS (Lower values – > benefit) (MCID 4.6))
Disability (follow up: 1 year; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22))
Quality of Life (follow up: 1 year; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4))
Quality of Life (follow up: 1 year; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1))
Withdrawal due to adverse events (follow up: 1 year)
Serious adverse events (follow up: 1 year)
Malignancy (follow up: 1 year)
Myocardial infarction (follow up: 1 year)
Death (follow up: 1 year)
Serious adverse events (from SRs on harms)
Malignancy (from SRs on harms)