Guideline: 2021 ACR RA
Clinical question: Should patients with MTX-naïve and non-MTX csDMARDs exposed RA and moderate to high disease activity receive MTX monotherapy or boDMARD monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs exposed RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Abatacept
Rituximab
IL-6 Receptor Inhibitor
JAK Inhibitor
Outcomes:
TNF Inhibitor: 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)
Remission (follow up: 2 years; assessed with: DAS28-ESR <2.6)
Radiographic progression (follow up: 2 years; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Disability (follow up: range 1 year to 2 years; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Fatigue (follow up: 2 years; assessed with: FACIT-F (Higher values – > benefit) (MCID 15.9)
Pain (follow up: 2 years; assessed with: VAS 0-100 (Lower values – > benefit) (MCID -11.9)
Quality of life (follow up: range 1 year to 2 years; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4)
Quality of life (follow up: range 1 year to 2 years; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1)
Serious adverse events (follow up: 2 years)
Withdrawal due to lack of efficacy (2 years)
Withdrawal due to adverse events (follow up: 2 years)
Death (follow up: 2 years)
Malignancy (follow up: 2 years)
Malignancy (from SRs on harms)
Cardiovascular disease (from SRs on harms)
Death (from SRs on harms)
Abatacept: Remission (follow up: 1 year; assessed with: DAS28-CRP < 2.6)
Disability (follow up: 1 year; assessed with: HAQ-DI (≥ 0.3)
Serious adverse events (1 year)
Withdrawal due to adverse events (follow up: 1 year)
Withdrawal due to lack of efficacy (follow up: 1 year)
Death (follow up: 1 year)
Malignancy (follow up: 1 year)
Malignancy (from SR of harms) ABA vs MTX
IL-6 Receptor Inhibitor: 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 <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 (1 year) (follow up: 1 year; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1)
Serious adverse events (follow up: 1 year)
Withdrawal due to lack of efficacy (follow up: 1 year)
Death (follow up: 1 year)
Malignancy (follow up: 1 year)
Myocardial infarction (follow up: 1 year)
Malignancy (from SRs of harms)
Serious adverse events (from SRs of harms)
JAK Inhibitor: 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 < 2.6)
Radiographic progression (follow up: 2 years; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Disability (follow up: 2 years; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Serious adverse events (follow up: 2 years)
Withdrawal due to adverse events (follow up: 2 years)
Death (follow up: 2 years)
Malignancy (follow up: 2 years)
Malignancy (from SRs on harms)