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Meta-Analysis
. 2009 Oct 7;2009(4):CD007277.
doi: 10.1002/14651858.CD007277.pub2.

Abatacept for rheumatoid arthritis

Lara Maxwell  1 , Jasvinder A Singh
Affiliations
Meta-Analysis

Abatacept for rheumatoid arthritis

Lara Maxwell et al. Cochrane Database Syst Rev. .

Abstract

Background: Abatacept inhibits the co-stimulation of T cells and disrupts the inflammatory chain of events that leads to joint inflammation, pain, and damage in rheumatoid arthritis.

Objectives: To assess the efficacy and safety of abatacept in reducing disease activity, pain, and improving function in people with rheumatoid arthritis.

Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 1), MEDLINE (from 1966), EMBASE (from 1980), ACP Journal Club (from 2000), and Biosis Previews (from 1990) in March 2007 and December 2008. We contacted authors of included studies and the abatacept manufacturer.

Selection criteria: Randomized controlled trials comparing abatacept alone, or in combination with disease-modifying anti-rheumatic drugs (DMARDs) or biologics, to placebo or other DMARDs or biologics in patients with moderate to severe rheumatoid arthritis.

Data collection and analysis: Two authors independently assessed search results and risk of bias, and extracted data. We obtained adverse event data from trials, long-term extension studies, and regulatory agencies.

Main results: Seven trials with 2908 patients were included. Compared with placebo, patients in the abatacept group were 2.2 times more likely to achieve an ACR 50 response at one year (RR 2.21, 95% confidence interval (CI) 1.73 to 2.82) with a 21% (95% CI 16% to 27%) absolute risk difference between groups. The number needed to treat to achieve an ACR 50 response was 5 (95% CI 4 to 7). Significant improvements in physical function and a reduction in disease activity and pain were found in abatacept-treated patients compared to placebo. One RCT found abatacept significantly slowed the radiographic progression of joint damage at 12 months compared to placebo, although it is not clear what the clinical relevance of this difference may be. There may be a risk of attrition bias. Total adverse events were greater in the abatacept group (RR 1.05, 95% CI 1.01 to 1.08). Other harm outcomes were not significant with the exception of a greater number of serious infections at 12 months in the abatacept group (Peto odds ratio 1.91 (95% CI 1.07 to 3.42). Serious adverse events were increased when abatacept was given in combination with other biologics (RR 2.30, 95% CI 1.15 to 4.62).

Authors' conclusions: There is moderate-level evidence that abatacept is efficacious and safe in the treatment of rheumatoid arthritis. Abatacept should not be used in combination with other biologics to treat rheumatoid arthritis. The withdrawal and toxicity profile appears acceptable at the present time but further long-term studies and post-marketing surveillance are required to assess harms and sustained efficacy.

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Conflict of interest statement

None known. This systematic review did not receive specific funding.

Figures

1
1
Search result flow diagram
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
4
4
Assessment of publication bias
1.1
1.1. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 1 ACR 20% improvement.
1.2
1.2. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 2 ACR 50% improvement.
1.3
1.3. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 3 ACR 70% improvement.
1.4
1.4. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 4 Improvement in physical function (HAQ: >0.22 or >0.3 increase from baseline, 0‐3 scale).
1.5
1.5. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 5 Achievement of low disease activity state (DAS 28<3.2, scale 0‐10).
1.6
1.6. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 6 Achievement of remission (DAS 28 <2.6, scale 0‐10).
1.7
1.7. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 7 DAS‐28 ESR.
1.8
1.8. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 8 SF‐36 physical component score ‐ % same.
1.9
1.9. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 9 SF‐36 physical component score ‐ % better.
1.10
1.10. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 10 SF‐36 physical component score ‐ % worse.
1.11
1.11. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 11 SF‐36 mental component score ‐ % same.
1.12
1.12. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 12 SF‐36 mental component score ‐ % better.
1.13
1.13. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 13 SF‐36 mental component score ‐ % worse.
1.14
1.14. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 14 SF‐36 mental component score.
1.15
1.15. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 15 SF‐36 physical component score.
1.16
1.16. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 16 No. achieving population norm SF‐36 physical component score ‐ 6 months.
1.17
1.17. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 17 Patient reported pain (100 mm VAS).
1.18
1.18. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 18 Patient global assessment.
1.19
1.19. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 19 Physician global assessment.
1.20
1.20. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 20 Physical function (HAQ‐DI & MHAQ).
1.21
1.21. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 21 Tender joint count.
1.22
1.22. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 22 Swollen joint count.
1.23
1.23. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 23 Radiographic progression (maximum erosion score 145).
1.24
1.24. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 24 Withdrawals due to adverse events.
1.25
1.25. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 25 All withdrawals.
1.26
1.26. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 26 Serious infections.
1.27
1.27. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 27 Upper respiratory infections.
1.28
1.28. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 28 Total adverse events.
1.29
1.29. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 29 Total serious adverse events.
1.30
1.30. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 30 Death.
1.31
1.31. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 31 Malignancies.
1.32
1.32. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 32 Cough.
1.33
1.33. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 33 Nausea.
1.34
1.34. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 34 Headache.
1.35
1.35. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 35 Dizziness.
1.36
1.36. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 36 Diarrhea.
1.37
1.37. Analysis
Comparison 1 Abatacept (2 mg/kg and 10 mg/kg) + DMARDs/biologic versus placebo + DMARDs/biologic, Outcome 37 Infusion reaction (within 24 hours after infusion).
2.1
2.1. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 1 ACR 20% improvement.
2.2
2.2. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 2 ACR 50% improvement.
2.3
2.3. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 3 ACR 70% improvement.
2.4
2.4. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 4 Physical function (mHAQ, 0‐3 scale).
2.5
2.5. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 5 Patient assessment of pain (100 mm VAS).
2.6
2.6. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 6 Withdrawals due to adverse events ‐ 12 months.
2.7
2.7. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 7 All withdrawals ‐ 12 months.
2.8
2.8. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 8 Serious infections ‐ 12 months.
2.9
2.9. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 9 Upper respiratory infections ‐ 12 months.
2.10
2.10. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 10 Total adverse events ‐ 12 months.
2.11
2.11. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 11 Total serious adverse events ‐ 12 months.
2.12
2.12. Analysis
Comparison 2 Abatacept (2 mg/kg) + etanercept versus placebo + etanercept, Outcome 12 Death ‐ 12 months.
3.1
3.1. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 1 Withdrawals due to adverse events ‐ 12 months.
3.2
3.2. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 2 All withdrawals ‐ 12 months.
3.3
3.3. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 3 Serious infections ‐ 12 months.
3.4
3.4. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 4 Upper respiratory infections ‐ 12 months.
3.5
3.5. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 5 Total adverse events ‐ 12 months.
3.6
3.6. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 6 Total serious adverse events ‐ 12 months.
3.7
3.7. Analysis
Comparison 3 Abatacept (2 mg/kg and 10 mg/kg) + biologic versus placebo + biologic, Outcome 7 Death ‐ 12 months.
4.1
4.1. Analysis
Comparison 4 Abatacept versus placebo (by dosage), Outcome 1 ACR 20% improvement.
4.2
4.2. Analysis
Comparison 4 Abatacept versus placebo (by dosage), Outcome 2 ACR 50% improvement.
4.3
4.3. Analysis
Comparison 4 Abatacept versus placebo (by dosage), Outcome 3 ACR 70% improvement.
5.1
5.1. Analysis
Comparison 5 Abatacept versus placebo (by study eligibility criteria), Outcome 1 ACR 20% improvement.
5.2
5.2. Analysis
Comparison 5 Abatacept versus placebo (by study eligibility criteria), Outcome 2 ACR 50% improvement.
5.3
5.3. Analysis
Comparison 5 Abatacept versus placebo (by study eligibility criteria), Outcome 3 ACR 70% improvement.
6.1
6.1. Analysis
Comparison 6 Abatacept versus placebo (funnel plot), Outcome 1 ACR 20% improvement ‐ 6 months.
6.2
6.2. Analysis
Comparison 6 Abatacept versus placebo (funnel plot), Outcome 2 ACR 50% improvement ‐ 6 months.
6.3
6.3. Analysis
Comparison 6 Abatacept versus placebo (funnel plot), Outcome 3 ACR 50% ‐ 1 year.
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