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Meta-Analysis
. 2010 Jan 20;2010(1):CD008341.
doi: 10.1002/14651858.CD008341.

Golimumab for rheumatoid arthritis

Jasvinder A Singh  1 , Shahrzad Noorbaloochi, Gurkirpal Singh
Affiliations
Meta-Analysis

Golimumab for rheumatoid arthritis

Jasvinder A Singh et al. Cochrane Database Syst Rev. .

Abstract

Background: Golimumab is a humanized inhibitor of Tumor necrosis factor-alpha, recently approved by the Food and Drug Administration (FDA) for the treatment of Rheumatoid arthritis (RA).

Objectives: The objective of this systematic review was to compare the efficacy and safety of golimumab (alone or in combination with DMARDs or biologics) to placebo (alone or in combination with DMARDs or biologics) in randomized or quasi-randomized clinical trials in adults with RA.

Search strategy: An expert librarian searched six databases for any clinical trials of golimumab in RA, including the Cochrane Central Register of Controlled Trials (CENTRAL), OVID MEDLINE, CINAHL, EMBASE, Science Citation Index (Web of Science) and Current Controlled Trials databases.

Selection criteria: Studies were included if they used golimumab in adults with RA, were randomized or quasi-randomized and provided clinical outcomes.

Data collection and analysis: Two review authors (JS, SN) independently reviewed all titles and abstracts, selected appropriate studies for full review and reviewed the full-text articles for the final selection of included studies. For each study, they independently abstracted study characteristics, safety and efficacy data and performed risk of bias assessment. Disagreements were resolved by consensus. For continuous measures, we calculated mean differences or standardized mean differences and for categorical measures, relative risks. 95% confidence intervals were calculated.

Main results: Four RCTs with 1,231 patients treated with golimumab and 483 patients treated with placebo were included. Of these, 436 were treated with the FDA-approved dose of golimumab 50 mg every four weeks. Compared to patients treated with placebo+methotrexate, patients treated with the FDA-approved dose of golimumab+methotrexate were 2.6 times more likely to reach ACR50 (95% confidence interval (CI) 1.3 to 4.9; P=0.005 and NNT= 5, 95% confidence interval 2 to 20), no more likely to have any adverse event (relative risk 1.1, 95% Cl 0.9 to 1.2; P=0.44), and 0.5 times as likely to have overall withdrawals (95% Cl 0.3 to 0.8; P=0.005). Golimumab-treated patients were significantly more likely to achieve remission, low disease activity and improvement in functional ability compared to placebo (all statistically significant). No significant differences were noted between golimumab and placebo regarding serious adverse events, infections, serious infections, lung infections, tuberculosis, cancer, withdrawals due to adverse events and inefficacy and deaths. No radiographic data were reported.

Authors' conclusions: With an overall high grade of evidence, at the FDA-approved dose, golimumab is significantly more efficacious than placebo in treatment of patients with active RA , when used in combination with methotrexate. The short-term safety profile, based on short-term RCTs, is reasonable with no differences in total adverse events, serious infections, cancer, tuberculosis or deaths. Long-term surveillance studies are needed for safety assessment.

PubMed Disclaimer

Conflict of interest statement

JS‐ Speaker honoraria from Abbott; research and travel grants from Takeda, Savient, Wyeth and Amgen; consultant fees from Savient and URL pharmaceuticals

SN‐ None

GS‐ Honoraria/consultant/research grants from Centocor, Abbott, AMGEN, Johnson and Johnson

Figures

1
1
Study Selection Flow Chart
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
1.1
1.1. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 1 ACR20 (14‐24 wk).
1.2
1.2. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 2 ACR50 (14‐24 wk).
1.3
1.3. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 3 ACR70 (14‐24 wk).
1.4
1.4. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 4 Good EULAR Response (14‐24 wk).
1.5
1.5. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 5 DAS Low Disease Activity (14‐16 wk).
1.6
1.6. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 6 DAS Remission (14‐24 wk).
1.7
1.7. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 7 HAQ Change ≥.22 (14 wk).
1.8
1.8. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 8 Change in HAQ score (14 wk).
1.9
1.9. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 9 HAQ Scores (14 wk).
1.10
1.10. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 10 Change in DAS28 Scores (16 wk).
1.11
1.11. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 11 Adverse Events (16‐24 wk).
1.12
1.12. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 12 Serious Adverse Events (16‐24 wk).
1.13
1.13. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 13 Infections (16‐24 wk).
1.14
1.14. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 14 Serious Infections (16‐24 wk).
1.15
1.15. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 15 Tuberculosis (16‐24 wk).
1.16
1.16. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 16 Lung Infections (16‐24 wk).
1.17
1.17. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 17 Cancer (16‐24 wk).
1.18
1.18. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 18 All Withdrawals (14‐24 wk).
1.19
1.19. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 19 Withdrawals due to Adverse Events (14‐16 wk).
1.20
1.20. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 20 Withdrawals due to Inefficacy (14‐16 wk).
1.21
1.21. Analysis
Comparison 1 Golimumab 50 mg every 4 weeks + MTX vs placebo + MTX, Outcome 21 Death (24‐52 wk).
2.1
2.1. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 1 ACR20 (14‐24 wk).
2.2
2.2. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 2 ACR50 (14‐24 wk).
2.3
2.3. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 3 ACR70 (14‐24 wk).
2.4
2.4. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 4 Good EULAR Response (14‐24 wk).
2.5
2.5. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 5 DAS Low Ds Activity (14‐16 wk).
2.6
2.6. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 6 DAS Remission (14‐24 wk).
2.7
2.7. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 7 HAQ Change ≥.22 (14 wk).
2.8
2.8. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 8 Change in HAQ score (14 wk).
2.9
2.9. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 9 HAQ Scores (14 wk).
2.10
2.10. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 10 Change in DAS28 Scores (16 wk).
2.11
2.11. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 11 Adverse Events (16‐24 wk).
2.12
2.12. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 12 Serious Adverse Events (16‐24 wk).
2.13
2.13. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 13 Infections (16‐24 wk).
2.14
2.14. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 14 Serious Infections (16‐24 wk).
2.15
2.15. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 15 Tuberculosis (16‐24 wk).
2.16
2.16. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 16 Lung Infections (16‐24 wk).
2.17
2.17. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 17 Cancer (16‐24 wk).
2.18
2.18. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 18 All Withdrawals (14‐24 wk).
2.19
2.19. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 19 Withdrawals due to Adverse Events (14‐16 wk).
2.20
2.20. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 20 Withdrawals due to Inefficacy (14‐16 wk).
2.21
2.21. Analysis
Comparison 2 Golimumab 100 mg q4 week + MTX vs placebo + MTX, Outcome 21 Death (24‐52 wk).
3.1
3.1. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 1 ACR20 (16 wk).
3.2
3.2. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 2 ACR50 (16 wk).
3.3
3.3. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 3 ACR70 (16 wk).
3.4
3.4. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 4 Good EULAR Response (16 wk).
3.5
3.5. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 5 DAS Low Ds Activity (16 wk).
3.6
3.6. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 6 DAS Remission (16 wk).
3.7
3.7. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 7 Change in DAS28 Scores (16 wk).
3.8
3.8. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 8 Adverse Events (20 wk).
3.9
3.9. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 9 Serious Adverse Events (20 wk).
3.10
3.10. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 10 Infections (20 wk).
3.11
3.11. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 11 Serious Infections (20 wk).
3.12
3.12. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 12 Tuberculosis (20 wk).
3.13
3.13. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 13 Cancer (20 wk).
3.14
3.14. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 14 All Withdrawals (16 wk).
3.15
3.15. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 15 Withdrawals due to Adverse Events (16 wk).
3.16
3.16. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 16 Withdrawals due to Inefficacy (16 wk).
3.17
3.17. Analysis
Comparison 3 Golimumab 50 mg q2 week + MTX vs placebo + MTX, Outcome 17 Death (52 wk).
4.1
4.1. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 1 ACR20 (16 wk).
4.2
4.2. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 2 ACR50 (16 wk).
4.3
4.3. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 3 ACR70 (16 wk).
4.4
4.4. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 4 Good EULAR Response (16 wk).
4.5
4.5. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 5 DAS Low Ds Activity (16 wk).
4.6
4.6. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 6 DAS Remission (16 wk).
4.7
4.7. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 7 Change in DAS28 Scores (16 wk).
4.8
4.8. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 8 Adverse Events (20 wk).
4.9
4.9. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 9 Serious Adverse Events (20 wk).
4.10
4.10. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 10 Infections (20 wk).
4.11
4.11. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 11 Serious Infections (20 wk).
4.12
4.12. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 12 Tuberculosis (20 wk).
4.13
4.13. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 13 Cancer (20 wk).
4.14
4.14. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 14 All Withdrawals (16 wk).
4.15
4.15. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 15 Withdrawals due to Adverse Events (16 wk).
4.16
4.16. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 16 Withdrawals due to Inefficacy (16 wk).
4.17
4.17. Analysis
Comparison 4 Golimumab 100 mg q2 week + MTX vs placebo + MTX, Outcome 17 Death (52 wk).
5.1
5.1. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 1 ACR20 (14‐24 wk).
5.2
5.2. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 2 ACR50 (14‐24 wk).
5.3
5.3. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 3 ACR70 (14‐24 wk).
5.4
5.4. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 4 Good EULAR Response (14‐24 wk).
5.5
5.5. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 5 DAS Remission (14‐24 wk).
5.6
5.6. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 6 HAQ Change ≥.22 (14 wk).
5.7
5.7. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 7 Change in HAQ scores (14 wk).
5.8
5.8. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 8 Adverse Events (16‐24 wk).
5.9
5.9. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 9 Serious Adverse Events (16‐24 wk).
5.10
5.10. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 10 Infections (16‐24 wk).
5.11
5.11. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 11 Serious Infections (16‐24 wk).
5.12
5.12. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 12 Tuberculosis (16‐24 wk).
5.13
5.13. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 13 Lung Infections (24 wk).
5.14
5.14. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 14 Cancer (16‐24 wk).
5.15
5.15. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 15 All Withdrawals (14‐24 wk).
5.16
5.16. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 16 Withdrawals due to Adverse Events (14 wk).
5.17
5.17. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 17 Withdrawals due to Inefficacy (14 wk).
5.18
5.18. Analysis
Comparison 5 Golimumab 100 mg every four weeks + placebo (oral) versus placebo (injections) + methotrexate: Comparison of Golimumab to Methotrexate, Outcome 18 Death (24 wk).
6.1
6.1. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 1 ACR20 (14‐24 wk).
6.2
6.2. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 2 ACR50 (14‐24 wk).
6.3
6.3. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 3 ACR70 (14‐24 wk).
6.4
6.4. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 4 Good EULAR Response (14‐24 wk).
6.5
6.5. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 5 DAS Low Ds Activity (14 wk).
6.6
6.6. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 6 DAS Remission (14‐16 wk).
6.7
6.7. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 7 HAQ Change ≥.22 (14 wk).
6.8
6.8. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 8 Change in HAQ score (14 wk).
6.9
6.9. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 9 HAQ Scores (14 wk).
6.10
6.10. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 10 Change in DAS28 Scores (16 wk).
6.11
6.11. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 11 Adverse Events (16‐24 wk).
6.12
6.12. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 12 Serious Adverse Events (16‐24 wk).
6.13
6.13. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 13 Infections (16‐24 wk).
6.14
6.14. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 14 Serious Infections (16‐24 wk).
6.15
6.15. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 15 Tuberculosis (16‐24 wk).
6.16
6.16. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 16 Lung Infections (16‐24 wk).
6.17
6.17. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 17 Cancer (16‐24 wk).
6.18
6.18. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 18 All Withdrawals (14‐24 wk).
6.19
6.19. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 19 Withdrawals due to Adverse Events (14‐16 wk).
6.20
6.20. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 20 Withdrawals due to Inefficacy (14‐24 wk).
6.21
6.21. Analysis
Comparison 6 Golimumab (all doses‐ 50 mg q4wks, 50 mg q2wks, 100 mg q4wks, 100 mg q2wks) + MTX vs placebo (injectable) + MTX, Outcome 21 Death (24‐52 wk).
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References

References to studies included in this review

Emery 2009 {published data only}
    1. Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. Golimumab, a human anti‐tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate‐naive patients with active rheumatoid arthritis: Twenty‐four‐week results of a phase III, multicenter, randomized, double‐blind, placebo‐controlled study of golimumab before methotrexate as first‐line therapy for early‐onset rheumatoid arthritis. Arthritis Rheum 2009;60(8):2272‐83. - PubMed
Kay 2008 {published data only}
    1. Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double‐blind, placebo‐controlled, dose‐ranging study. Arthritis Rheum 2008;58:964‐75. - PubMed
Keystone 2009 {published data only}
    1. Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, et al. Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO‐FORWARD Study. Ann Rheum Dis 2009;68:789‐96. - PMC - PubMed
Smolen 2009 {published data only}
    1. Smolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO‐AFTER study): a multicentre, randomised, double‐blind, placebo‐controlled, phase III trial. Lancet 2009;374(9685):210‐21. - PubMed

References to studies excluded from this review

O'Connell 2008 {published data only}
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Oldfield 2009 {published data only}
    1. Oldfield V, Plosker GL. Golimumab: in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Bio Drugs 2009;23:125‐35. - PubMed

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