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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Disease activity (follow up: 2 years; assessed with: ACR 50)
Importance: CRITICAL

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: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. Unexplained heterogeneity I2=75%.
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: TNF inhibitor: 188/451 (41.7%)
MTX monotherapy: 182/426 (42.7%)
Effect: Relative Effect (95% CI): RR 0.98 (0.84 to 1.14)
Absolute Effect (95% CI): 9 fewer per 1,000 (from 68 fewer to 60 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Disease activity (follow up: 2 years; assessed with: ACR 70)
Importance: CRITICAL

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: TNF inhibitor: 128/451 (28.4%)
MTX monotherapy: 113/426 (26.5%)
Effect: Relative Effect (95% CI): RR 1.07 (0.86 to 1.33)
Absolute Effect (95% CI): 19 more per 1,000 (from 37 fewer to 88 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Remission (follow up: 2 years; assessed with: DAS28-ESR <2.6)
Importance: CRITICAL

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: TNF inhibitor: 69/274 (25.2%)
MTX monotherapy: 64/257 (24.9%)
Effect: Relative Effect (95% CI): RR 1.01 (0.75 to 1.36)
Absolute Effect (95% CI): 2 more per 1,000 (from 62 fewer to 90 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Radiographic progression (follow up: 2 years; assessed with: mTSS (Lower values – > benefit) (MCID 4.6)
Importance: CRITICAL

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: TNF inhibitor: 177
MTX monotherapy: 169
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 1.9 lower (3.19 lower to 0.61 lower)(The study PREMIER found that the RR of developing no radiographic progression (change in mTSS ≤0.5) was 1.33 (95%CI 1.07 to 1.65), absolute risk increase 112 more per 1000 (95%CI 24 more to 220 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Disability (follow up: range 1 year to 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: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNF inhibitor: 481
MTX monotherapy: 474
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.01 higher (0.07 lower to 0.1 higher)(The study PREMIER found that the RR of improvement in HAQ-DI (≥0.22 change from baseline) was 0.92 (95%CI 0.80 to 1.06), absolute risk reduction 50 fewer per 1000 (95%CI 126 fewer to 38 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Fatigue (follow up: 2 years; 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: TNF inhibitor: 272
MTX monotherapy: 254
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 1.7 lower (3.09 lower to 0.31 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Pain (follow up: 2 years; assessed with: VAS 0-100 (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: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNF inhibitor: 273
MTX monotherapy: 256
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 7.1 higher (4.34 higher to 9.86 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Quality of life (follow up: range 1 year to 2 years; 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: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. I2=67%. Question whether heterogeneity might be related to the use of different TNFis.
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: VERY LOW
No of participants: TNF inhibitor: 471
MTX monotherapy: 464
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 0.56 lower (1.73 lower to 0.6 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Quality of life (follow up: range 1 year to 2 years; 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
rationales: Indication of serious inconsistency I2=59% (taken into consideration when downgrading for imprecision). Question whether heterogeneity might be related to the use of different TNFis.
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 harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNF inhibitor: 471
MTX monotherapy: 464
Effect: Relative Effect (95% CI): -
Absolute Effect (95% CI): MD 1.98 lower (3.18 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
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: SERIOUS
rationales: Downgraded by one level due to serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting harm.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNF inhibitor: 92/274 (33.6%)
MTX monotherapy: 68/257 (26.5%)
Effect: Relative Effect (95% CI): RR 1.27 (0.98 to 1.65)
Absolute Effect (95% CI): 71 more per 1,000 (from 5 fewer to 172 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Withdrawal due to lack of efficacy (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: TNF inhibitor: 68/481 (14.1%)
MTX monotherapy: 69/474 (14.6%)
Effect: Relative Effect (95% CI): RR 0.95 (0.70 to 1.30)
Absolute Effect (95% CI): 7 fewer per 1,000 (from 44 fewer to 44 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
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: SERIOUS
rationales: Downgraded by one level due to serious inconsistency. Unexplained heterogeneity I2=72%.
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: TNF inhibitor: 41/481 (8.5%)
MTX monotherapy: 46/474 (9.7%)
Effect: Relative Effect (95% CI): RR 0.88 (0.59 to 1.32)
Absolute Effect (95% CI): 12 fewer per 1,000 (from 40 fewer to 31 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
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: SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting harm. Low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNF inhibitor: 4/274 (1.5%)
MTX monotherapy: 1/257 (0.4%)
Effect: Relative Effect (95% CI): RR 3.75 (0.42 to 33.35)
Absolute Effect (95% CI): 11 more per 1,000 (from 2 fewer to 126 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
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: SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Confidence interval includes both values suggesting no effect and values suggesting harm. Low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNF inhibitor: 8/481 (1.7%)
MTX monotherapy: 7/474 (1.5%)
Effect: Relative Effect (95% CI): RR 1.13 (0.41 to 3.08)
Absolute Effect (95% CI): 2 more per 1,000 (from 9 fewer to 31 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Malignancy (from SRs on harms)

Evidence assessment:
GRADE: result_interpretation: The systematic review RefID=3394, 2014 (RCTs=28, n=11741) comparing any TNFi vs placebo + MTX among RA showed that for cancer, the result was OR=1.30 (95% CI 0.80,2.14 Modified ITT model) [OR=1.06 (95% CI 0.64,1.75; p=0.82) Per protocol model]
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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Cardiovascular disease (from SRs on harms)

Evidence assessment:
GRADE: result_interpretation: The systematic review RefID=1105, 2017 (NRS=7, n=49003) comparing any TNFi vs csDMARDs among RA showed that for Cardiovascular disease, the result was RR = 0.62 (95% CI 0.44–0.88), p=0.007
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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: TNF Inhibitor
Outcome: Death (from SRs on harms)

Evidence assessment:
GRADE: result_interpretation: The systematic review RefID=1105, 2017 (NRS=5, n=41579) comparing any TNFi vs csDMARD among RA showed that for Death, the result was RR = 0.60 (95% CI 0.38–0.94), p=0.03
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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: Abatacept
Outcome: Remission (follow up: 1 year; assessed with: DAS28 - CRP < 2.6)
Importance: CRITICAL

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
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. Small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: ABA: 48/113 (42.5%)
MTX monotherapy: 52/115 (45.2%)
Effect: Relative Effect (95% CI): RR 0.94 (0.70 to 1.26)
Absolute Effect (95% CI): 27 fewer per 1,000 (from 136 fewer to 118 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 monotherapy or tsDMARD monotherapy?
Population: Patients with MTX-naïve and non-MTX csDMARDs naïve RA and moderate to high disease activity
Intervention: MTX monotherapy
Comparator: Abatacept
Outcome: Disability (follow up: 1 year; assessed with: HAQ - DI ≥ 0.3)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: NOT_SERIOUS
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. Small sample size.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: ABA: 61/113 (54.0%)
MTX monotherapy: 51/115 (44.3%)
Effect: Relative Effect (95% CI): RR 1.22 (0.93 to 1.59)
Absolute Effect (95% CI): 98 more per 1,000 (from 31 fewer to 262 more)
Abbreviations: CI: Confidence interval; RR: Risk ratio; MD: Mean difference; HR: Hazard Ratio