Evidence
This page contains a snapshot of featured content which highlights evidence addressing key clinical questions including areas of uncertainty. Please see the main topic reference list for details of all sources underpinning this topic.
BMJ Best Practice evidence tables
Evidence tables provide easily navigated layers of evidence in the context of specific clinical questions, using GRADE and a BMJ Best Practice Effectiveness rating. Follow the links at the bottom of the table, which go to the related evidence score in the main topic text, providing additional context for the clinical question. Find out more about our evidence tables.
This table is a summary of the analysis reported in a guideline (underpinned by a systematic review) that focuses on the above important clinical question.
Confidence in the evidence is very low or low where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for key outcomes. However, this is uncertain and new evidence could change this in the future.
Population: People with early rheumatoid arthritis (RA) and moderate or high disease activity
Intervention: TNF-alpha inhibitor plus methotrexate
Comparison: Combination traditional DMARDs; or a non-TNF biologic plus methotrexate; or tofacitinib (a JAK inhibitor) plus methotrexate
| Outcome | Effectiveness (BMJ rating)? | Confidence in evidence (GRADE)? |
|---|---|---|
TNF-alpha inhibitor plus methotrexate versus triple DMARD therapy (methotrexate, sulfasalazine, and hydroxychloroquine) | ||
ACR20 response (RA disease activity) | No statistically significant difference | Low |
ACR50 response (RA disease activity) | No statistically significant difference | Low |
ACR70 response (RA disease activity) | No statistically significant difference | Low |
Sharp radiographic progression score (higher score indicates more severe radiographic progression) | Favors intervention | Low |
Serious adverse events (SAEs) | No statistically significant difference | Low |
Infections and infestations | Occurs more commonly with a TNF-alpha inhibitor plus methotrexate compared with triple DMARD therapy (favors comparison) | Low |
Hepatotoxicity (Swedish reporting criteria) | No statistically significant difference | Low |
Gastrointestinal adverse events | Occurs more commonly with triple DMARD therapy compared with methotrexate plus TNF-alpha inhibitor (favors intervention) | Low |
TNF-alpha inhibitor plus methotrexate versus non-TNF biologic plus methotrexate | ||
DAS-28 (RA disease activity) (higher score indicates more severe disease activity) | No statistically significant difference | Low |
ACR50 response (RA disease activity) | No statistically significant difference | Low |
Health Assessment Questionnaire-Disability Index (HAQ-DI) (higher score indicates more severe physical disability) | No statistically significant difference | Low |
Sharp radiographic progression score (higher score indicates more severe disease progression) | No statistically significant difference | Low |
SAEs | No statistically significant difference | Low |
Serious infections | No statistically significant difference | Low |
Malignancies | No statistically significant difference | Low |
Local injection site reactions | Occurs more commonly with a TNF-alpha inhibitor plus methotrexate compared with a non-TNF biologic plus methotrexate (favors intervention) | Low |
TNF-alpha inhibitor plus methotrexate versus tofacitinib plus methotrexate | ||
DAS-28 <2.6 (RA disease activity) (percentage of participants achieving DAS-28 remission) | No statistically significant difference | Low |
ACR20 response (RA disease activity) | No statistically significant difference | Low |
HAQ-DI (higher score indicates more severe physical disability) | Favors comparison | Low |
SAEs | No statistically significant difference | Low |
Serious infections | No statistically significant difference | Low |
Hepatotoxicity (ALT>3x upper limit of normal) | No statistically significant difference | Very Low |
Recommendations as stated in the source guideline The 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis makes the following recommendations: If disease activity remains moderate or high despite DMARD monotherapy (with or without a glucocorticoid), use combination traditional DMARDs or a TNF-alpha inhibitor or a non-TNF biologic agent (all choices with or without methotrexate, in no particular order of preference), rather than continuing DMARD monotherapy alone (strong recommendation; low-quality evidence. If disease activity remains moderate or high despite combination traditional DMARDs, use a TNF-alpha inhibitor plus methotrexate over tofacitinib plus methotrexate (conditional recommendation; low-quality evidence)
Note The guideline committee rated the first recommendation in this table as strong, despite the low quality of evidence, because clinical experience and indirect evidence supports the benefits of adding the listed treatment options as opposed to continuing with monotherapy. The guideline panel also agreed that whenever possible, biologic therapy should be in combination with methotrexate due to superior efficacy compared with biologic monotherapy. The second recommendation was rated as conditional due to the low quality of the evidence and potential long-term safety concerns of tofacitinib.
This evidence table is related to the following section/s:
Cochrane Clinical Answers
Cochrane Clinical Answers (CCAs) provide a readable, digestible, clinically focused entry point to rigorous research from Cochrane systematic reviews. They are designed to be actionable and to inform decision making at the point of care and have been added to relevant sections of the main Best Practice text.
- In people with rheumatoid arthritis, how does abatacept affect outcomes?
- What are the effects of adding a disease‐modifying antirheumatic drug (DMARD) to methotrexate (MTX) for people with rheumatoid arthritis who are MTX naïve?
- In people with rheumatoid arthritis, how does golimumab affect outcomes?
- How do disease modifying anti-rheumatic drugs compare in terms of adverse events?
- Does evidence from randomized controlled trials support the use of certolizumab (CDP870) for adults with rheumatoid arthritis?
- What is the effect of adding a disease‐modifying antirheumatic drug (DMARD) to methotrexate (MTX) for people with rheumatoid arthritis and an inadequate response to MTX alone?
- In patients receiving methotrexate for rheumatoid arthritis, do folic acid and folinic acid reduce side effects?
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