somewordstoolate/Q2CRBench-3 huggingface dataset:
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
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: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi: 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 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
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: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi: 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 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
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: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: MODERATE
No of participants: TNFi: 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 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
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: NOT_SERIOUS
Imprecision: result: NOT_SERIOUS
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: LOW
No of participants: TNFi: 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 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
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: NOT_SERIOUS
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: LOW
No of participants: TNFi: 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 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
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: NOT_SERIOUS
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: LOW
No of participants: TNFi: 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 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
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: 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.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNFi: 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 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
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: 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.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: TNFi: 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 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
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: NOT_SERIOUS
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: LOW
No of participants: TNFi: 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 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
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: NOT_SERIOUS
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: LOW
No of participants: TNFi: 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 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
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 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
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 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
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 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: 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: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
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: VERY 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 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: 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: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
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: VERY 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
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: Abatacept
Outcome: Serious adverse events (1 year)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
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: VERY LOW
No of participants: ABA: 14/116 (12.1%)
MTX monotherapy: 9/116 (7.8%)
Effect: Relative Effect (95% CI): RR 1.56 (0.70 to 3.45)
Absolute Effect (95% CI): 43 more per 1,000 (from 23 fewer to 190 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 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: Abatacept
Outcome: Withdrawal due to adverse events (follow up: 1 year)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
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: VERY LOW
No of participants: ABA: 8/116 (6.9%)
MTX monotherapy: 5/116 (4.3%)
Effect: Relative Effect (95% CI): RR 1.60 (0.54 to 4.75)
Absolute Effect (95% CI): 26 more per 1,000 (from 20 fewer to 162 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 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: Abatacept
Outcome: Withdrawal due to lack of efficacy (follow up: 1 year)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
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: VERY LOW
No of participants: ABA: 6/116 (5.2%)
MTX monotherapy: 11/116 (9.5%)
Effect: Relative Effect (95% CI): RR 0.55 (0.21 to 1.43)
Absolute Effect (95% CI): 43 fewer per 1,000 (from 75 fewer to 41 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 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: Abatacept
Outcome: Death (follow up: 1 year)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Small sample size and very low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: ABA: 0/116 (0.0%)
MTX monotherapy: 0/116 (0.0%)
Effect: Relative Effect (95% CI): not estimable
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 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: Abatacept
Outcome: Malignancy (follow up: 1 year)
Importance: IMPORTANT

Evidence assessment:
GRADE: Risk of bias: result: NOT_SERIOUS
Inconsistency: result: NOT_SERIOUS
Indirectness: result: SERIOUS
rationales: Downgraded by one level due to serious indirectness. The evidence is based on a population naive to non-MTX csDMARDs.
Imprecision: result: VERY_SERIOUS
rationales: Downgraded by two levels due to very serious imprecision. Small sample size and very low number of events.
Other considerations: result: none
Study design: Randomized Controlled Trial
Certainty: VERY LOW
No of participants: ABA: 2/116 (1.7%)
MTX monotherapy: 1/116 (0.9%)
Effect: Relative Effect (95% CI): RR 2.00 (0.18 to 21.75)
Absolute Effect (95% CI): 9 more per 1,000 (from 7 fewer to 179 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 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: Abatacept
Outcome: Malignancy (from SR of harms) ABA vs MTX

Evidence assessment:
GRADE: result_interpretation: The Systematic Review RefID=1220, 2017 (RCTs=4, n=Not provided) comparing Abatacept vs Placebo + csDMARD among RA and showed that for Cancer, the result was Peto OR=1.12 (0.33, 3.81)
Study design: Systematic Review