somewordstoolate/Q2CRBench-3 huggingface dataset:
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: Rituximab + MTX
Outcome: Radiographic progression (follow up: 2 years; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: RTX+MTX: 244
MTX monotherapy: 233
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 1.54 lower (2.3 lower to 0.78 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Pain (follow up: 1 year; assessed with: VAS pain (Lower values – > benefit) (MCID -11.9)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 12.2 lower (16.15 lower to 8.25 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Fatigue (follow up: 1 year; assessed with: FACIT-F (Higher values – > benefit) (MCID 15.9)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: RTX+MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 3.45 higher (1.77 higher to 5.13 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Disability (follow up: 2 years; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 250
MTX monotherapy: 249
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.25 lower (0.4 lower to 0.1 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Quality of Life (follow up: 1 year; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 3.53 higher (2.04 higher to 5.02 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Quality of Life (follow up: 1 year; assessed with: SF-36 MCS (Higher values – > benefit) (MCID 3.1)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: RTX+MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.81 higher (1.03 lower to 2.66 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Withdrawal due to adverse events (follow up: 2 years)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting benefit.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 7/250 (2.8%)
MTX monotherapy: 17/249 (6.8%)
Effect: Relative Effect (95% CI): RR 0.41 (0.17 to 0.97)
Absolute Effect (95% CI): 40 fewer per 1,000 (from 57 fewer to 2 fewer)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Serious adverse events (follow up: 2 years)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting benefit and values suggesting harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 33/250 (13.2%)
MTX monotherapy: 42/249 (16.9%)
Effect: Relative Effect (95% CI): RR 0.78 (0.51 to 1.19)
Absolute Effect (95% CI): 37 fewer per 1,000 (from 83 fewer to 32 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Malignancy (follow up: 2 years)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting benefit and values suggesting harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 3/250 (1.2%)
MTX monotherapy: 7/249 (2.8%)
Effect: Relative Effect (95% CI): RR 0.43 (0.11 to 1.63)
Absolute Effect (95% CI): 16 fewer per 1,000 (from 25 fewer to 18 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Death (follow up: 2 years)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Downgraded by one level due to serious risk of bias. Lack of allocation concealment.
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting benefit and values suggesting harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: RTX+MTX: 1/250 (0.4%)
MTX monotherapy: 3/249 (1.2%)
Effect: Relative Effect (95% CI): RR 0.33 (0.03 to 3.17)
Absolute Effect (95% CI): 8 fewer per 1,000 (from 12 fewer to 26 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: Rituximab + MTX
Outcome: Malignancy (from SRs on harms)

Evidence assessment:
GRADE: result_interpretation: The Systematic Review RefID=4638, 2012 (RCTs=3, n=2435) comparing Abatacept + csDMARD vs Placebo + csDMARD among RA showed that for Cancer, the result was RR=0.65 (0.25-1.7) at 1 year. 
Study design: Systematic Review
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: IL-6 Receptor Inhibitor + MTX
Outcome: Disease activity (follow up: 1 year; assessed with: ACR 20)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 374/578 (64.7%)
MTX monotherapy: 164/287 (57.1%)
Effect: Relative Effect (95% CI): RR 1.13 (1.01 to 1.27)
Absolute Effect (95% CI): 74 more per 1,000 (from 6 more to 154 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Disease activity (follow up: 1 year; assessed with: ACR 50)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 314/578 (54.3%)
MTX monotherapy: 117/287 (40.8%)
Effect: Relative Effect (95% CI): RR 1.33 (1.14 to 1.56)
Absolute Effect (95% CI): 135 more per 1,000 (from 57 more to 228 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Disease activity (follow up: 1 year; assessed with: ACR 70)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 234/578 (40.5%)
MTX monotherapy: 84/287 (29.3%)
Effect: Relative Effect (95% CI): RR 1.38 (1.13 to 1.70)
Absolute Effect (95% CI): 111 more per 1,000 (from 38 more to 205 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Disease activity (follow up: 1 year; assessed with: DAS28-ESR (Lower values – > benefit) (MCID -1.17))
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 578
MTX monotherapy: 287
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.83 lower (1.09 lower to 0.57 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Remission (follow up: 1 year; assessed with: DAS28-ESR remission <2.6)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 240/578 (41.5%)
MTX monotherapy: 56/287 (19.5%)
Effect: Relative Effect (95% CI): RR 2.13 (1.65 to 2.74)
Absolute Effect (95% CI): 220 more per 1,000 (from 127 more to 340 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Radiographic progression (follow up: 1 year; assessed with: mTSS (Lower values – > benefit) (MCID 4.6))
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 540
MTX monotherapy: 267
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.89 lower (1.45 lower to 0.33 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Disability (follow up: 1 year; assessed with: HAQ-DI (Lower values – > benefit) (MCID -0.22))
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.14 lower (0.22 lower to 0.06 lower)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio
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: IL-6 Receptor Inhibitor + MTX
Outcome: Quality of Life (follow up: 1 year; assessed with: SF-36 PCS (Higher values – > benefit) (MCID 4.4))
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: SERIOUS
rationales: Rated down by one level for lack of allocation concealment
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a non-MTX csDMARD exposed population.
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TCZ+MTX: 0
MTX monotherapy: 0
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 1.99 higher (0.41 higher to 3.57 higher)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio