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Meta-Analysis
. 2017 Sep 8;9(9):CD007649.
doi: 10.1002/14651858.CD007649.pub4.

Certolizumab pegol (CDP870) for rheumatoid arthritis in adults

Vicente Ruiz Garcia  1 , Amanda Burls, Juan B Cabello, Paloma Vela Casasempere, Sylvia Bort-Marti, José A Bernal
Affiliations
Meta-Analysis

Certolizumab pegol (CDP870) for rheumatoid arthritis in adults

Vicente Ruiz Garcia et al. Cochrane Database Syst Rev. .

Abstract

Background: Tumour necrosis factor (TNF)-alpha inhibitors are beneficial for the treatment of rheumatoid arthritis (RA) for reducing the risk of joint damage, improving physical function and improving the quality of life. This review is an update of the 2014 Cochrane Review of the treatment of RA with certolizumab pegol.

Objectives: To assess the clinical benefits and harms of certolizumab pegol (CZP) in people with RA who have not responded well to conventional disease-modifying anti-rheumatic drugs (DMARDs).

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL: Cochrane Library 2016, Issue 9), MEDLINE, Embase, Web of Knowledge, reference lists of articles, clinicaltrials.gov and ICTRP of WHO. The searches were updated from 2014 (date of the last search for the previous version) to 26 September 2016.

Selection criteria: Randomised controlled trials that compared certolizumab pegol with any other agent, including placebo or methotrexate (MTX), in adults with active RA, regardless of current or prior treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs), such as MTX.

Data collection and analysis: Two review authors independently checked search results, extracted data and assessed trial quality. We resolved disagreements by discussion or referral to a third review author.

Main results: We included 14 trials in this update, three more than previously. Twelve trials (5422 participants) included measures of benefit. We pooled 11 of them, two more than previously. Thirteen trials included information on harms, (5273 participants). The duration of follow-up varied from 12 to 52 weeks and the range of doses of certolizumab pegol varied from 50 to 400 mg given subcutaneously. In Phase III trials, the comparator was placebo plus MTX in seven trials and placebo in five. In the two Phase II trials the comparator was only placebo.The approved dose of certolizumab pegol, 200 mg every other week, produced clinically important improvements at 24 weeks for the following outcomes:- American College of Rheumatology (ACR) 50% improvement (pain, function and other symptoms of RA): 25% absolute improvement (95% confidence interval (CI) 20% to 33%); number need to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 5); risk ratio (RR) 3.80 (95% CI 2.42 to 5.95), 1445 participants, 5 studies.- The Health Assessment Questionnaire (HAQ): -12% absolute improvement (95% CI -9% to -14%); NNTB of 8 (95% CI 7 to 11); mean difference (MD) - 0.35 (95% CI -0.43 to -0.26; 1268 participants, 4 studies) (scale 0 to 3; lower scores mean better function).- Proportion of participants achieving remission (Disease Activity Score (DAS) < 2.6) absolute improvement 10% (95% CI 8% to 16%); NNTB of 8 (95% CI 6 to 12); risk ratio (RR) 2.94 (95% CI 1.64 to 5.28), 2420 participants, six studies.- Radiological changes: erosion score (ES) absolute improvement -0.29% (95% CI -0.42% to -0.17%); NNTB of 6 (95% CI 4 to 10); MD -0.67 (95% CI -0.96 to -0.38); 714 participants, two studies (scale 0 to 230), but not a clinically important difference.-Serious adverse events (SAEs) were statistically but not clinically significantly more frequent for certolizumab pegol (200 mg every other week) with an absolute rate difference of 3% (95% CI 1% to 4%); number needed to treat for an additional harmful outcome (NNTH) of 33 (95% CI 25 to 100); Peto odds ratio (OR) 1.47 (95% CI 1.13 to 1.91); 3927 participants, nine studies.There was a clinically significant increase in all withdrawals in the placebo groups (for all doses and at all follow-ups) with an absolute rate difference of -29% (95% CI -16% to -42%), NNTH of 3 (95% CI 2 to 6), RR 0.47 (95% CI 0.39 to 0.56); and there was a clinically significant increase in withdrawals due to adverse events in the certolizumab groups (for all doses and at all follow-ups) with an absolute rate difference of 2% (95% CI 0% to 3%); NNTH of 58 (95% CI 28 to 329); Peto OR 1.45 (95% CI 1.09 to 1.94) 5236 participants Twelve studies.We judged the quality of evidence to be high for ACR50, DAS remission, SAEs and withdrawals due to adverse events, and moderate for HAQ and radiological changes, due to concerns about attrition bias. For all withdrawals we judged the quality of evidence to be moderate, due to inconsistency.

Authors' conclusions: The results and conclusions did not change from the previous review. There is a moderate to high certainty of evidence from randomised controlled trials that certolizumab pegol, alone or combined with methotrexate, is beneficial in the treatment of RA for improved ACR50 and health-related quality of life, an increased chance of remission of RA, and reduced joint damage as seen on x-ray. Fewer people stopped taking their treatment, but most of these who did stopped due to serious adverse events. Adverse events were more frequent with active treatment. We found a clinically but not statistically significant risk of serious adverse events.

PubMed Disclaimer

Conflict of interest statement

UCB paid Dr Vicente Ruiz's registration for the Cochrane meeting in Madrid 2011. In 2011 and 2012 he attended the UCB Advisory Board meetings in Madrid when the sponsor explained details and preliminary results for the new trials of certolizumab pegol. He did not receive any economic or other kind of compensation for these meetings.

Burls A: none known.

Cabello JB: none known.

Vela Casasempere P: "I have participated as a member of advisory boards for Roche and Pfizer. I have also received fees for development of educational presentations for Roche, Abbvie, UCB, BMS and MSD, and travel and accommodations expenses to attend scientific meetings from Pfizer, Abbvie and Roche".

Bort‐Marti S: none known.

Bernal JA: "I have received travel and accommodations expenses to attend scientific meetings from Pfizer and MSD".

Figures

1
1
Update: Records identified through the databases: (n = 559) Additional records identified through other sources (Clinicaltrials.gov, ICRTP)
 (n = 98) Flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison 49: Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), outcome: 49.8 Deaths.
1.1
1.1. Analysis
Comparison 1 Efficacy at 12 weeks, any dose, Outcome 1 ACR20.
1.2
1.2. Analysis
Comparison 1 Efficacy at 12 weeks, any dose, Outcome 2 ACR50.
1.3
1.3. Analysis
Comparison 1 Efficacy at 12 weeks, any dose, Outcome 3 ACR70.
2.1
2.1. Analysis
Comparison 2 ACR50 24 weeks, 200 mg certolizumab pegol, Outcome 1 ACR 50.
3.1
3.1. Analysis
Comparison 3 ACR50 at 24 weeks, 400 mg certolizumab, Outcome 1 ACR 50.
4.1
4.1. Analysis
Comparison 4 ACR50 at 52 weeks, 200 mg certolizumab, Outcome 1 ACR 50.
5.1
5.1. Analysis
Comparison 5 ACR50 at 52 weeks, 400 mg certolizumab, Outcome 1 ACR 50.
6.1
6.1. Analysis
Comparison 6 Mean HAQ‐DI from baseline at week 12, Outcome 1 certolizumab pegol 200 mg sc.
7.1
7.1. Analysis
Comparison 7 Mean HAQ‐DI from baseline at week 24, Outcome 1 certolizumab pegol 200 mg sc.
7.2
7.2. Analysis
Comparison 7 Mean HAQ‐DI from baseline at week 24, Outcome 2 certolizumab 400 mg sc.
8.1
8.1. Analysis
Comparison 8 HAQ‐DI at 24 weeks, any dose, Outcome 1 Change from baseline.
9.1
9.1. Analysis
Comparison 9 HAQ‐DI at 52 weeks, any dose, Outcome 1 Change from baseline.
10.1
10.1. Analysis
Comparison 10 SF‐36 Physical Component Summary (PCS), week 24, Outcome 1 certolizumab pegol 200 mg sc.
10.2
10.2. Analysis
Comparison 10 SF‐36 Physical Component Summary (PCS), week 24, Outcome 2 certolizumab pegol 400 mg sc.
11.1
11.1. Analysis
Comparison 11 SF‐36 Mental Component Summary (MCS), week 24, Outcome 1 certolizumab pegol 200 mg sc.
11.2
11.2. Analysis
Comparison 11 SF‐36 Mental Component Summary (MCS), week 24, Outcome 2 certolizumab pegol 400 mg sc.
12.1
12.1. Analysis
Comparison 12 SF‐36 Physical Component Summary (PCS), week 52, Outcome 1 certolizumab 200 mg sc.
12.2
12.2. Analysis
Comparison 12 SF‐36 Physical Component Summary (PCS), week 52, Outcome 2 certolizumab 400 mg sc.
13.1
13.1. Analysis
Comparison 13 SF‐36 Mental Component Summary (MCS), week 52, Outcome 1 certolizumab pegol 200 mg sc.
13.2
13.2. Analysis
Comparison 13 SF‐36 Mental Component Summary (MCS), week 52, Outcome 2 certolizumab pegol 400 mg sc.
14.1
14.1. Analysis
Comparison 14 SF‐36 Physical Component Summary (PCS) at week 24, any dose, Outcome 1 Change from baseline.
15.1
15.1. Analysis
Comparison 15 SF‐36 Mental Component Summary (MCS) at week 24, any dose, Outcome 1 Change from baseline.
16.1
16.1. Analysis
Comparison 16 SF‐36 Physical Component Summary (PCS) at week 52, any dose, Outcome 1 Change from baseline.
17.1
17.1. Analysis
Comparison 17 SF‐36 Mental Component Summary (MCS) at week 52, any dose, Outcome 1 Change from baseline.
18.1
18.1. Analysis
Comparison 18 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any doses, 12 weeks, Outcome 1 Proportion of participants achieving remission 12 weeks certolizumab 200 mg.
19.1
19.1. Analysis
Comparison 19 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any dose, 24 weeks, Outcome 1 Proportion of participants achieving remission 24 weeks.
20.1
20.1. Analysis
Comparison 20 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any dose, 52 weeks, Outcome 1 Proportion of participants achieving remission 52 weeks.
21.1
21.1. Analysis
Comparison 21 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any time, Outcome 1 Proportion of participants achieving remission 12 weeks certolizumab 200 mg.
21.2
21.2. Analysis
Comparison 21 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any time, Outcome 2 Proportion of participants achieving remission 24 weeks certolizumab 200 mg.
21.3
21.3. Analysis
Comparison 21 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any time, Outcome 3 Proportion of participants achieving remission 24 weeks certolizumab 400 mg.
21.4
21.4. Analysis
Comparison 21 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any time, Outcome 4 Proportion of participants achieving remission 52 weeks certolizumab 200 mg.
21.5
21.5. Analysis
Comparison 21 Disease Activity Score (DAS‐28) (ESR) remission (< 2.6), any time, Outcome 5 Proportion of participants achieving remission 52 weeks certolizumab 400 mg.
22.1
22.1. Analysis
Comparison 22 DAS‐28 at 12 weeks, 200 mg certolizumab, Outcome 1 DAS 28 (ESR) change from baseline.
23.1
23.1. Analysis
Comparison 23 DAS‐28 at 24 weeks, 400 mg certolizumab, Outcome 1 DAS 28 (ESR) change from baseline.
24.1
24.1. Analysis
Comparison 24 DAS‐28 at week 52, certolizumab 200 mg, Outcome 1 DAS 28 (ESR) Change from baseline.
25.1
25.1. Analysis
Comparison 25 DAS‐28 at week 52, certolizumab 400 mg, Outcome 1 DAS 28 (ESR) Change from baseline.
26.1
26.1. Analysis
Comparison 26 DAS‐28 at 24 weeks, any dose, Outcome 1 Change from baseline.
27.1
27.1. Analysis
Comparison 27 DAS‐28 at 52 weeks, any dose, Outcome 1 Change from baseline.
28.1
28.1. Analysis
Comparison 28 DAS‐28 at 24 weeks, 200 mg certolizumab, Outcome 1 DAS 28 (ESR) change from baseline.
29.1
29.1. Analysis
Comparison 29 Erosion score (ES), Outcome 1 Change from the baseline mean ES at week 24, certolizumab pegol 200 mg.
29.2
29.2. Analysis
Comparison 29 Erosion score (ES), Outcome 2 Change from the baseline mean ES at week 24, certolizumab pegol 400 mg.
29.3
29.3. Analysis
Comparison 29 Erosion score (ES), Outcome 3 Change from the baseline mean ES at week 52, certolizumab pegol 200 mg.
29.4
29.4. Analysis
Comparison 29 Erosion score (ES), Outcome 4 Change from the baseline mean ES at week 52, certolizumab pegol 400 mg.
30.1
30.1. Analysis
Comparison 30 Erosion score (ES) at 24 weeks, any dose, Outcome 1 Change from baseline.
31.1
31.1. Analysis
Comparison 31 Erosion score (ES) at 52 weeks, any dose, Outcome 1 Change from baseline.
32.1
32.1. Analysis
Comparison 32 Joint space narrowing (JSN), Outcome 1 Change from the baseline mean JSN 24 weeks, certolizumab pegol 200 mg.
32.2
32.2. Analysis
Comparison 32 Joint space narrowing (JSN), Outcome 2 Change from the baseline mean JSN 24 weeks,certolizumab pegol 400 mg.
32.3
32.3. Analysis
Comparison 32 Joint space narrowing (JSN), Outcome 3 Change from the baseline mean JSN 52 weeks,certolizumab pegol 200 mg.
32.4
32.4. Analysis
Comparison 32 Joint space narrowing (JSN), Outcome 4 Change from the baseline mean JSN 52 weeks, certolizumab pegol 400 mg.
33.1
33.1. Analysis
Comparison 33 Joint space narrowing (JSN) at 24 weeks, any dose, Outcome 1 Change from baseline.
34.1
34.1. Analysis
Comparison 34 Joint space narrowing (JSN) at 52 weeks, any dose, Outcome 1 Change from baseline.
35.1
35.1. Analysis
Comparison 35 Modified Total Sharp Scores (mTSS) at 24 weeks, any dose, Outcome 1 Change from baseline.
36.1
36.1. Analysis
Comparison 36 Modified Total Sharp Scores (mTSS) at 52 weeks, any dose, Outcome 1 Change from baseline.
37.1
37.1. Analysis
Comparison 37 Modified total Sharp scores (mTSS), Outcome 1 Change from the baseline mean mTSS 24 weeks, certolizumab pegol 200 mg.
37.2
37.2. Analysis
Comparison 37 Modified total Sharp scores (mTSS), Outcome 2 Change from the baseline mean mTSS 24 weeks, certolizumab 400 mg.
37.3
37.3. Analysis
Comparison 37 Modified total Sharp scores (mTSS), Outcome 3 Change from the baseline mean mTSS 52 weeks, certolizumab pegol 200 mg.
37.4
37.4. Analysis
Comparison 37 Modified total Sharp scores (mTSS), Outcome 4 Change from the baseline mean mTSS 52 weeks, certolizumab pegol 400 mg.
38.1
38.1. Analysis
Comparison 38 Certolizumab pegol 1mg/kg/day sc, Outcome 1 Headache.
38.2
38.2. Analysis
Comparison 38 Certolizumab pegol 1mg/kg/day sc, Outcome 2 Lower respiratory tract infection.
38.3
38.3. Analysis
Comparison 38 Certolizumab pegol 1mg/kg/day sc, Outcome 3 Adverse events Intensity severe.
38.4
38.4. Analysis
Comparison 38 Certolizumab pegol 1mg/kg/day sc, Outcome 4 Antinuclear antibodies (ANA).
38.5
38.5. Analysis
Comparison 38 Certolizumab pegol 1mg/kg/day sc, Outcome 5 Urinary tract infection.
39.1
39.1. Analysis
Comparison 39 Certolizumab 5 mg/kg/day sc, Outcome 1 Lower respiratory tract infection.
39.2
39.2. Analysis
Comparison 39 Certolizumab 5 mg/kg/day sc, Outcome 2 Urinary tract infection.
40.1
40.1. Analysis
Comparison 40 Certolizumab 20 mg/kg/day sc, Outcome 1 Headache.
40.2
40.2. Analysis
Comparison 40 Certolizumab 20 mg/kg/day sc, Outcome 2 Lower respiratory tract infection.
40.3
40.3. Analysis
Comparison 40 Certolizumab 20 mg/kg/day sc, Outcome 3 Death.
40.4
40.4. Analysis
Comparison 40 Certolizumab 20 mg/kg/day sc, Outcome 4 Antinuclear antibodies (ANA).
40.5
40.5. Analysis
Comparison 40 Certolizumab 20 mg/kg/day sc, Outcome 5 Urinary tract infection.
41.1
41.1. Analysis
Comparison 41 Safety, SAE certolizumab 200 mg, Outcome 1 Serious Adverse Events (SAE).
42.1
42.1. Analysis
Comparison 42 Safety, SAE certolizumab 400 mg, Outcome 1 Serious Adverse Events (SAEs).
43.1
43.1. Analysis
Comparison 43 Withdrawals, Outcome 1 All Withdrawn: any doses any follow‐up.
43.2
43.2. Analysis
Comparison 43 Withdrawals, Outcome 2 Withdrawals due to adverse events.
44.1
44.1. Analysis
Comparison 44 ACR at 24 weeks, any dose, Outcome 1 ACR20.
44.2
44.2. Analysis
Comparison 44 ACR at 24 weeks, any dose, Outcome 2 ACR50.
44.3
44.3. Analysis
Comparison 44 ACR at 24 weeks, any dose, Outcome 3 ACR70.
45.1
45.1. Analysis
Comparison 45 ACR at 52 weeks, any dose, Outcome 1 ACR20.
45.2
45.2. Analysis
Comparison 45 ACR at 52 weeks, any dose, Outcome 2 ACR50.
45.3
45.3. Analysis
Comparison 45 ACR at 52 weeks, any dose, Outcome 3 ACR70.
46.1
46.1. Analysis
Comparison 46 ACR20‐ACR70, 24 weeks, 200 mg certolizumab pegol, Outcome 1 ACR 20.
46.2
46.2. Analysis
Comparison 46 ACR20‐ACR70, 24 weeks, 200 mg certolizumab pegol, Outcome 2 ACR 70.
47.1
47.1. Analysis
Comparison 47 ACR20‐ACR70 at 24 weeks, 400 mg certolizumab, Outcome 1 ACR 20.
47.2
47.2. Analysis
Comparison 47 ACR20‐ACR70 at 24 weeks, 400 mg certolizumab, Outcome 2 ACR 70.
48.1
48.1. Analysis
Comparison 48 ACR20‐ACR70 at 52 weeks, 200 mg certolizumab, Outcome 1 ACR 20.
48.2
48.2. Analysis
Comparison 48 ACR20‐ACR70 at 52 weeks, 200 mg certolizumab, Outcome 2 ACR 70.
49.1
49.1. Analysis
Comparison 49 ACR20‐ACR70 at 52 weeks, 400 mg certolizumab, Outcome 1 ACR 20.
49.2
49.2. Analysis
Comparison 49 ACR20‐ACR70 at 52 weeks, 400 mg certolizumab, Outcome 2 ACR 70.
50.1
50.1. Analysis
Comparison 50 Safety, Outcome 1 Any adverse event certolizumab 200 mg.
50.2
50.2. Analysis
Comparison 50 Safety, Outcome 2 Any adverse events certolizumab 400 mg.
50.3
50.3. Analysis
Comparison 50 Safety, Outcome 3 Adverse events: Intensity mild certolizumab 200 mg.
50.4
50.4. Analysis
Comparison 50 Safety, Outcome 4 Adverse events: Intensity mild certolizumab 400 mg.
50.5
50.5. Analysis
Comparison 50 Safety, Outcome 5 Adverse events: Intensity moderate certolizumab 200 mg.
50.6
50.6. Analysis
Comparison 50 Safety, Outcome 6 Adverse events: Intensity moderate certolizumab 400 mg.
50.7
50.7. Analysis
Comparison 50 Safety, Outcome 7 Adverse events: Intensity severe certolizumab 200 mg.
50.8
50.8. Analysis
Comparison 50 Safety, Outcome 8 Adverse events: Intensity severe certolizumab 400 mg.
50.9
50.9. Analysis
Comparison 50 Safety, Outcome 9 Adverse events related to study drug certolizumab 200 mg.
50.10
50.10. Analysis
Comparison 50 Safety, Outcome 10 Adverse events related to study drug certolizumab 400 mg.
50.11
50.11. Analysis
Comparison 50 Safety, Outcome 11 Serious Infections certolizumab 200 mg.
50.12
50.12. Analysis
Comparison 50 Safety, Outcome 12 Serious infections certolizumab 400 mg.
50.13
50.13. Analysis
Comparison 50 Safety, Outcome 13 Adverse events leading to death certolizumab 200 mg.
50.14
50.14. Analysis
Comparison 50 Safety, Outcome 14 Adverse events leading to death certolizumab 400 mg.
50.15
50.15. Analysis
Comparison 50 Safety, Outcome 15 Adverse events leading to withdrawal certolizumab 200 mg.
50.16
50.16. Analysis
Comparison 50 Safety, Outcome 16 Adverse events leading to withdrawal certolizumab 400 mg.
50.17
50.17. Analysis
Comparison 50 Safety, Outcome 17 Death certolizumab 200 mg.
50.18
50.18. Analysis
Comparison 50 Safety, Outcome 18 Death certolizumab 400 mg.
50.19
50.19. Analysis
Comparison 50 Safety, Outcome 19 Deaths overall.
50.20
50.20. Analysis
Comparison 50 Safety, Outcome 20 Tuberculosis certolizumab 200 mg.
50.21
50.21. Analysis
Comparison 50 Safety, Outcome 21 Tuberculosis certolizumab 400 mg.
50.22
50.22. Analysis
Comparison 50 Safety, Outcome 22 Tuberculosis overall.
50.23
50.23. Analysis
Comparison 50 Safety, Outcome 23 Malignancies included lymphoma certolizumab 200 mg.
50.24
50.24. Analysis
Comparison 50 Safety, Outcome 24 Malignancies included lymphoma certolizumab 400 mg.
50.25
50.25. Analysis
Comparison 50 Safety, Outcome 25 Injection side reactions certolizumab 200 mg.
50.26
50.26. Analysis
Comparison 50 Safety, Outcome 26 Injection side reactions certolizumab 400 mg.
50.27
50.27. Analysis
Comparison 50 Safety, Outcome 27 Antinuclear antibodies (ANA) Anti‐certolizumab pegol antibodies certolizumab 200 mg.
50.28
50.28. Analysis
Comparison 50 Safety, Outcome 28 Anti‐certolizumab pegol antibodies certolizumab 400 mg.
50.29
50.29. Analysis
Comparison 50 Safety, Outcome 29 Systemic lupus erythematosus certolizumab 200 mg.
50.30
50.30. Analysis
Comparison 50 Safety, Outcome 30 Prolonged activated partial thromboplastin time (aPTT) certolizumab 200 mg.
50.31
50.31. Analysis
Comparison 50 Safety, Outcome 31 Prolonged activated partial thromboplastin time (aPTT) certolizumab 400 mg.
50.32
50.32. Analysis
Comparison 50 Safety, Outcome 32 Urinary tract infection certolizumab 200 mg.
50.33
50.33. Analysis
Comparison 50 Safety, Outcome 33 Urinary tract infection certolizumab 400 mg.
50.34
50.34. Analysis
Comparison 50 Safety, Outcome 34 Upper respiratory tract infection certolizumab 200 mg.
50.35
50.35. Analysis
Comparison 50 Safety, Outcome 35 Upper respiratory tract infection certolizumab 400 mg.
50.36
50.36. Analysis
Comparison 50 Safety, Outcome 36 Lower respiratory tract infection/ lung infection certolizumab 200 mg.
50.37
50.37. Analysis
Comparison 50 Safety, Outcome 37 Lower respiratory tract infection/ lung infection certolizumab 400 mg.
50.38
50.38. Analysis
Comparison 50 Safety, Outcome 38 Pneumonia certolizumab 200 mg.
50.39
50.39. Analysis
Comparison 50 Safety, Outcome 39 Pneumonitis certolizumab 400 mg.
50.40
50.40. Analysis
Comparison 50 Safety, Outcome 40 Headache certolizumab 200 mg.
50.41
50.41. Analysis
Comparison 50 Safety, Outcome 41 Headache certolizumab 400 mg.
50.42
50.42. Analysis
Comparison 50 Safety, Outcome 42 Bacteriuria certolizumab 200 mg.
50.43
50.43. Analysis
Comparison 50 Safety, Outcome 43 Bacteriuria certolizumab 400 mg.
50.44
50.44. Analysis
Comparison 50 Safety, Outcome 44 Nasopharyngitis/Pharyngitis certolizumab 200 mg.
50.45
50.45. Analysis
Comparison 50 Safety, Outcome 45 Nasopharyngitis/Pharyngitis certolizumab 400 mg.
50.46
50.46. Analysis
Comparison 50 Safety, Outcome 46 Injection site pain certolizumab 200 mg.
50.47
50.47. Analysis
Comparison 50 Safety, Outcome 47 Injection site pain certolizumab 400 mg.
50.48
50.48. Analysis
Comparison 50 Safety, Outcome 48 Hypertension certolizumab 200 mg.
50.49
50.49. Analysis
Comparison 50 Safety, Outcome 49 Hypertension certolizumab 400 mg.
50.50
50.50. Analysis
Comparison 50 Safety, Outcome 50 Hematuria certolizumab 200 mg.
50.51
50.51. Analysis
Comparison 50 Safety, Outcome 51 Haematuria certolizumab 400 mg.
50.52
50.52. Analysis
Comparison 50 Safety, Outcome 52 Hepatic enzyme increased certolizumab 200 mg.
50.53
50.53. Analysis
Comparison 50 Safety, Outcome 53 Hepatic enzyme increased certolizumab 400 mg.
50.54
50.54. Analysis
Comparison 50 Safety, Outcome 54 AST increased certolizumab 200 mg.
50.55
50.55. Analysis
Comparison 50 Safety, Outcome 55 AST increased certolizumab 400 mg.
50.56
50.56. Analysis
Comparison 50 Safety, Outcome 56 ALT increased certolizumab 200 mg.
50.57
50.57. Analysis
Comparison 50 Safety, Outcome 57 ALT increased certolizumab 400 mg.
50.58
50.58. Analysis
Comparison 50 Safety, Outcome 58 Diarrhoea certolizumab 200 mg.
50.59
50.59. Analysis
Comparison 50 Safety, Outcome 59 Gastroenteritis certolizumab 200 mg.
50.60
50.60. Analysis
Comparison 50 Safety, Outcome 60 Gastrointestinal disorders certolizumab 400 mg.
50.61
50.61. Analysis
Comparison 50 Safety, Outcome 61 Back pain certolizumab 200 mg.
50.62
50.62. Analysis
Comparison 50 Safety, Outcome 62 Back pain certolizumab 400 mg.
50.63
50.63. Analysis
Comparison 50 Safety, Outcome 63 Hematologic abnormalities certolizumab 200 mg.
50.64
50.64. Analysis
Comparison 50 Safety, Outcome 64 Haematologic abnormalities certolizumab 400 mg.
50.65
50.65. Analysis
Comparison 50 Safety, Outcome 65 Herpes viral infection certolizumab 200 mg.
50.66
50.66. Analysis
Comparison 50 Safety, Outcome 66 Herpes viral infection certolizumab 400 mg.
50.67
50.67. Analysis
Comparison 50 Safety, Outcome 67 Bacterial peritonitis certolizumab 200 mg.
50.68
50.68. Analysis
Comparison 50 Safety, Outcome 68 Bacterial peritonitis certolizumab 400 mg.
50.69
50.69. Analysis
Comparison 50 Safety, Outcome 69 Opportunistic infections certolizumab 200 mg.
50.70
50.70. Analysis
Comparison 50 Safety, Outcome 70 Opportunistic infections certolizumab 400 mg.
50.71
50.71. Analysis
Comparison 50 Safety, Outcome 71 Infections and infestations certolizumab 200 mg.
50.72
50.72. Analysis
Comparison 50 Safety, Outcome 72 Infections and infestations certolizumab 400 mg.
50.73
50.73. Analysis
Comparison 50 Safety, Outcome 73 Decreased haemoglobin certolizumab 200 mg.
50.74
50.74. Analysis
Comparison 50 Safety, Outcome 74 Decreased haemoglobin certolizumab 400 mg.
50.75
50.75. Analysis
Comparison 50 Safety, Outcome 75 Increased platelet count certolizumab 200 mg.
50.76
50.76. Analysis
Comparison 50 Safety, Outcome 76 Increased platelet count certolizumab 400 mg.
50.77
50.77. Analysis
Comparison 50 Safety, Outcome 77 Cerebral haemorrhage including subarachnoid certolizumab 200 mg.
50.78
50.78. Analysis
Comparison 50 Safety, Outcome 78 Ischaemic stroke certolizumab 400 mg.
50.79
50.79. Analysis
Comparison 50 Safety, Outcome 79 Nausea/vomiting certolizumab 200 mg.
50.80
50.80. Analysis
Comparison 50 Safety, Outcome 80 Vomiting certolizumab 400 mg.
50.81
50.81. Analysis
Comparison 50 Safety, Outcome 81 Acute miocardial infarction certolizumab 200 mg.
50.82
50.82. Analysis
Comparison 50 Safety, Outcome 82 Acute myocardial infarction certolizumab 400 mg.
50.83
50.83. Analysis
Comparison 50 Safety, Outcome 83 Abdominal pain/discomfort/dyspepsia certolizumab 200 mg.
50.84
50.84. Analysis
Comparison 50 Safety, Outcome 84 Constipation certolizumab 200 mg.
50.85
50.85. Analysis
Comparison 50 Safety, Outcome 85 Skin and subcutaneous tissue disorders certolizumab 200 mg.
50.86
50.86. Analysis
Comparison 50 Safety, Outcome 86 Skin and subcutaneous tissue disorders certolizumab 400 mg.
50.87
50.87. Analysis
Comparison 50 Safety, Outcome 87 Cough certolizumab 200 mg.
50.88
50.88. Analysis
Comparison 50 Safety, Outcome 88 Pruritus certolizumab 200 mg.
50.89
50.89. Analysis
Comparison 50 Safety, Outcome 89 Fatigue certolizumab 200 mg.
50.90
50.90. Analysis
Comparison 50 Safety, Outcome 90 Fatigue certolizumab 400 mg.
50.91
50.91. Analysis
Comparison 50 Safety, Outcome 91 Periodontitis certolizumab 200 mg.
50.92
50.92. Analysis
Comparison 50 Safety, Outcome 92 Arthritis bacterial certolizumab 400 mg.
50.93
50.93. Analysis
Comparison 50 Safety, Outcome 93 Mastitis certolizumab 400 mg.
50.94
50.94. Analysis
Comparison 50 Safety, Outcome 94 Benign tumour certolizumab 400 mg.
50.95
50.95. Analysis
Comparison 50 Safety, Outcome 95 Dizziness postural certolizumab 400 mg.
50.96
50.96. Analysis
Comparison 50 Safety, Outcome 96 Menorrhagia certolizumab 400 mg.
50.97
50.97. Analysis
Comparison 50 Safety, Outcome 97 Corneal perforation certolizumab 400 mg.
50.98
50.98. Analysis
Comparison 50 Safety, Outcome 98 Conjunctivitis allergic certolizumab 400 mg.
50.99
50.99. Analysis
Comparison 50 Safety, Outcome 99 Periodontitis certolizumab 400 mg.
51.1
51.1. Analysis
Comparison 51 Participant's assessment of arthritis pain (VAS score 0 to 100 mm), Outcome 1 Mean change at 24 weeks certolizumab pegol 200 mg.
51.2
51.2. Analysis
Comparison 51 Participant's assessment of arthritis pain (VAS score 0 to 100 mm), Outcome 2 Mean change at 24 weeks certolizumab pegol 400 mg.
51.3
51.3. Analysis
Comparison 51 Participant's assessment of arthritis pain (VAS score 0 to 100 mm), Outcome 3 Mean change at 52 weeks certolizumab pegol 200 mg.
51.4
51.4. Analysis
Comparison 51 Participant's assessment of arthritis pain (VAS score 0 to 100 mm), Outcome 4 Mean change at 52 weeks certolizumab pegol 400 mg.
52.1
52.1. Analysis
Comparison 52 Participant's assessment of arthritis pain (VAS score 0 to 100 mm) at 24 weeks, any dose, Outcome 1 Change from baseline.
53.1
53.1. Analysis
Comparison 53 Participant's assessment of arthritis pain (VAS score 0 to 100 mm) at 52 weeks, any dose, Outcome 1 Change from baseline.
54.1
54.1. Analysis
Comparison 54 Withdrawals Withdrawn due to lack of efficacy: any doses any follow‐up, Outcome 1 Withdrawn due to lack of efficacy: any doses any follow‐up.
55.1
55.1. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 1 ACR 50 200 mg certolizumab 24 weeks.
55.2
55.2. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 2 HAQ change from baseline 200 mg certolizumab 24 weeks.
55.3
55.3. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 3 Serious adverse events certolizumab 200 mg sc.
55.4
55.4. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 4 Proportion of participants achieving remission 24 weeks certolizumab 200 mg.
55.5
55.5. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 5 Radiological changes: Erosion Scores (ES) certolizumab 200 mg sc.
55.6
55.6. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 6 All Withdrawals:.
55.7
55.7. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 7 Withdrawals due to adverse events.
55.8
55.8. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 8 Deaths.
55.9
55.9. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 9 Tuberculosis.
55.10
55.10. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 10 Upper respiratory tract infections.
55.11
55.11. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 11 Lower respiratory tract infections.
55.12
55.12. Analysis
Comparison 55 Summary of findings: certolizumab (with or without MTX) versus placebo (with or without MTX), Outcome 12 Malignancies including lymphoma.
56.1
56.1. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 1 Doses.
56.2
56.2. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 2 Size.
56.3
56.3. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 3 Use of MTX.
56.4
56.4. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 4 Population.
56.5
56.5. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 5 Duration of previous disease.
56.6
56.6. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 6 Published vs unpublished studies.
56.7
56.7. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 7 Imputing to ACR50 200 mg from 24 missing values with same proportion as reported outcomes.
56.8
56.8. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 8 Imputing to ACR50 200 mg from 24 weeks 50 % of missing outcomes.
56.9
56.9. Analysis
Comparison 56 Analysis of sensitivity ACR50 24 weeks, Outcome 9 Imputing to ACR50 200 mg from 24 weeks: the worst case.
57.1
57.1. Analysis
Comparison 57 Analysis of sensitivity ACR50 52 weeks, Outcome 1 Doses.
57.2
57.2. Analysis
Comparison 57 Analysis of sensitivity ACR50 52 weeks, Outcome 2 Size.
57.3
57.3. Analysis
Comparison 57 Analysis of sensitivity ACR50 52 weeks, Outcome 3 Use of MTX.
57.4
57.4. Analysis
Comparison 57 Analysis of sensitivity ACR50 52 weeks, Outcome 4 Population.
57.5
57.5. Analysis
Comparison 57 Analysis of sensitivity ACR50 52 weeks, Outcome 5 Duration of previous disease.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Atsumi 2016 {published data only}
    1. Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, et al. Baseline parameters identified in early, methotrexate‐naive rheumatoid arthritis patients with better outcomes with certolizumab pegol+methotrexate compared to placebo+methotrexate: Post‐hoc analyses of c‐opera, a randomized, controlled, phase 3 study. Annals of the Rheumatic Diseases.Conference: Annual European Congress of Rheumatology of the European League Against Rheumatism, EULAR 2015 Rome Italy. 10 ‐ 13 June 2015. 2015; Vol. 74:716‐7.
    1. Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, et al. Clinical benefit of 1‐year certolizumab pegol treatment in MTX‐naïve, early rheumatoid arthritis patients is maintained after discontinuation up to 1 year. Arthritis and Rheumatology.Conference: American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting, ACR/ARHP 2015 San Francisco, CA United States. 6 ‐ 11 November 2015. 2015; Vol. 67.
    1. Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, et al. The first double‐blind, randomised, parallel‐group certolizumab pegol study in methotrexate‐naive early rheumatoid arthritis patients with poor prognostic factors, C‐OPERA, shows inhibition of radiographic progression. Annals of the Rheumatic Diseases 2016;75(1):75‐83. - PMC - PubMed
    1. Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, et al. The first early rheumatoid arthritis, certolizumab pegol, multicenter, double‐blind, randomized, parallel‐group study: C‐Opera, in patients fulfilling the 2010 ACR/EULAR classification criteria, demonstrates inhibition of joint damage progression. Annals of the Rheumatic Diseases.Conference: Annual European Congress of Rheumatology of the European League Against Rheumatism, EULAR 2014 Paris France. 11 ‐ 14 June 2014. 2014; Vol. 73.
    1. Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, et al. The first, multicenter, double‐blind, randomized, parallel‐group study of certolizumab pegol in early rheumatoid arthritis demonstrates inhibition of joint damage progression. Arthritis and Rheumatology.Conference: 2014 ACR/ARHP Annual Meeting Boston, MA United States. 14 ‐ 19 November 2014. 2014; Vol. 66:S1078‐9.
CDP870‐004 2001 {published and unpublished data}
    1. Emery P, Smolen J, Choy E, et al. CDP870 a novel, humanised tumour necrosis factor alpha inhibitor improves HRQOL. Late breaking abstract. European League Against Rheumatism Annual Conference. 2002.
    1. European Medicines Agency. Assesment report for Cimzia. Procedure No EMEA/H/C/001037. www.ema.europa.eu/docs/en_GB/document_library/EPAR_‐_Public_assessment_r.... London, 2009 (accessed 3rd July 2017):1‐47. [Procedure No.EMEA/H/C/001037]
    1. Keystone E, Choy E, Kalden J, Klareskog, Sany J, Smolen J, et al. CDP870, A novel pegylated, humanized TNF‐alpha inhibitor, is effective in treating the signs and symptoms of rheumatoid arthritis (RA). Abstract to Rheumatology annual scientific meeting [abstract # LB‐3]. 2001.
Choy 2002 {published data only}
    1. Choy EH, Hazleman B, Smith M, Moss K, Lisi L, Scott DG, et al. Efficacy of a novel pegylated humanized anti‐TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double‐blinded, randomized, dose‐escalating trial. Rheumatology (Oxford) 2002;41(10):1133‐7. - PubMed
Choy 2012 {published data only}
    1. Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford) 2012;51(7):1226‐34. - PubMed
    1. UCB. Clinical Study Summary Study No.: CDP870‐014. www.ucb.com/_up/ucb_com_patients/documents/C87032_CSS_20080608.pdf 2008 (accessed 3rd July 2017).
Emery 2015 {published data only}
    1. Emery P, Bingham C, Burmester GR, Bykerk VP, Furst D, Mariette X, et al. Improvements in workplace and household productivity following 52 weeks of treatment with certolizumab pegol in combination with methotrexate in DMARD‐naive patients with severe, active and progressive rheumatoid arthritis: Results from the c‐early randomized, double‐blind, controlled phase 3 study. Value in Health.Conference: ISPOR 18th Annual European Congress Milan, Italy.Conference. 7 ‐ 11 November 2015. 2015; Vol. 18:7.
    1. Emery P, Bingham CO, Burmester G‐R, Bykerk VP, Furst DE, Mariette X, et al. Improvements in patient‐reported outcomes and workplace and household productivity following 52 weeks of treatment with certolizumab pegol in combination with methotrexate in DMARD‐naive early rheumatoid arthritis patients: Results from the C‐early randomized, double‐blind, controlled phase 3 study. Annals of the Rheumatic Diseases.Conference: Annual European Congress of Rheumatology of the European League Against Rheumatism, EULAR 2015 Rome Italy. 10 ‐ 13 June 2015. 2015; Vol. 74:712‐3.
    1. Emery P, Bingham CO, Burmester G‐R, Bykerk VP, Furst DE, Mariette X, et al. SAT0165 Improvements in patient‐reported outcomes and workplace and household productivity following 52 weeks of treatment with certolizumab pegol in combination with methotrexate in dmard‐naïve early rheumatoid arthritis patients: results from the C‐Early randomized, double‐blind, controlled phase 3 study. Annals of the Rheumatic Diseases 2015;74(Suppl 2):712‐3.
    1. Emery P, Bingham CO, Burmester G‐R, Bykerk VP, Furst DE, Mariette X, et al. sSAT0164 The first study of certolizumab pegol in combination with methotrexate in dmard‐naïve early rheumatoid arthritis patients led to Sustained clinical response and inhibition of radiographic progression at 52 weeks: The C‐Early randomized, double‐blind, controlled phase 3 study. Annals of the Rheumatic Diseases 2015;74(Suppl 2):712.
    1. Weinblatt M, Bingham C, Burmester G, Bykerk V, Furst DE, Mariette X, et al. Early response as a predictor of long‐term remission in DMARD‐naive patients with severe, active and progressive rheumatoid arthritis treated with certolizumab pegol in combination with methotrexate. Arthritis and Rheumatology.Conference: American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting, ACR/ARHP 2015 San Francisco, CA United States. 6 ‐ 11 November 2015. 2015; Vol. 67.
Fleischmann 2009 {published data only}
    1. Fleischmann D, Mason D, Cohen S. Efficacy and safety of certolizumab pegol monotherapy in patients with rheumatoid arthritis failing previous DMARD therapy. Annals of the Rheumatic Diseases 2007;66 Suppl II:169. - PMC - PubMed
    1. Fleischmann R, Keininger DL, Tahiri‐Fitzgerald E, Mease P. Certolizumab pegol monotherapy 400mg every 4 weeks improves physical functioning and reduces pain in patients with rheumatoid arthritis Who have previously failed DMARD therapy. Program and abstracts of the European League Against Rheumatism (EULAR) Annual Meeting; Barcelona, Spain 13‐16 June [Abstract #0148]. 2007.
    1. Fleischmann R, Vencovsky J, Vollenhoven RF, Borenstein D, Box J, Coteur G, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease modifying antirheumatic therapy: the FAST4WARD study. Annals of the Rheumatic Diseases 2009;68(6):805‐11. - PMC - PubMed
    1. Keystone E, Mason D, Fleischmann R. Certolizumab pegol 400 mg every 4 weeks as monotherapy rapidly reduces disease activity in active rheumatoid arthritis. Program and abstracts of the American College of Rheumatology (ACR) 71st Annual Meeting; November 6 ‐ 11; Boston, Massachusetts. [Abstract #277]. 2007.
    1. Strand V, Brown M, Purcaru O, Richard L. Certolizumab pegol monotherapy improves productivity in patients with active rheumatoid arthritis: results from a phase III randomized controlled trial. Program and abstracts of the European League Against Rheumatism (EULAR) Annual Meeting; Barcelona, Spain 13 ‐ 16 June [Abstract #0478]. 2007.
Keystone 2008 {published data only}
    1. Curtis JR, Chen L, Luijtens K, Navarro‐Millan I, Goel N, Gervitz L, et al. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient‐level data. Arthritis and Rheumatism 2011;63(8):2203‐8. - PubMed
    1. Curtis JR, Luijtens K, Kavanaugh A. Predicting future response to certolizumab pegol in rheumatoid arthritis patients: features at 12 weeks associated with low disease activity at 1 year. Arthritis Care Research (Hoboken) 2012;64(5):658‐67. - PMC - PubMed
    1. Haraoui B, Bykerk VP, Vollenhoven R, Longueville M, Luijtens K, Ralston P, et al. Analysis of pooled data from two randomized controlled trials and their open‐label extensions: Long‐term safety in rheumatoid arthritis before and after certolizumab pegol dose increase/decrease. Arthritis and Rheumatology.Conference: 2014 ACR/ARHP Annual Meeting Boston, MA United States 14 ‐ 19 N0vember 2014. 2014; Vol. 66:S199.
    1. Keystone E, Heijde D, Mason D Jr, Landewé R, Vollenhoven RV, Combe B, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty‐two‐week, phase III, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study. Arthritis and Rheumatism 2008;58(11):3319‐29. - PubMed
    1. Keystone E, Landewé R, Vollenhoven R, Combe B, Strand V, Mease P, et al. 5‐Year results from the RAPID 1 trial and open‐label extension: long‐term safety and efficacy of certolizumab pegol in combination with methotrexate in the treatment of rheumatoid arthritis. Annals of the Rheumatic Diseases 2013;72(12):A228‐9. [10.1136/annrheumdis‐2013‐203695. [Epub ahead of print]] - PMC - PubMed
NCT00993317 {published data only}
    1. NCT00993317. A study of CDP870 as add‐on medication to methotrexate (MTX) in patients with rheumatoid arthritis. clinicaltrials.gov/ct2/show/study/NCT00993317 (firs treceived 9th October 2009).
Smolen 2009 {published data only}
    1. Haraoui B, Bykerk VP, Vollenhoven R, Longueville M, Luijtens K, Ralston P, et al. Analysis of pooled data from two randomized controlled trials and their open‐label extensions: Long‐term safety in rheumatoid arthritis before and after certolizumab pegol dose increase/decrease. Arthritis and Rheumatology.Conference: 2014 ACR/ARHP Annual Meeting Boston, MA United States 14 ‐ 19 N0vember 2014. 2014; Vol. 66:S199.
    1. Kavanaugh A, Smolen JS, Emery P, Purcaru O, Keystone E, Richard L, et al. Effect of certolizumab pegol with methotrexate on home and work place productivity and social activities in patients with active rheumatoid arthritis. Arthritis and Rheumatism 2009;61(11):1592‐600. - PubMed
    1. Landewé R, Strand V, Smolen J, Heijde D. Liquid formulation certolizumab pegol with methotrexate decreases progression of structural joint damage in rheumatoid arthritis patients: the RAPID 2 study. Program and abstracts of the American College of Rheumatology (ACR) 71st Annual Meeting; 6 ‐ 11 November 2007; Boston, Massachusetts. [Abstract #696]. 2007.
    1. Mease P, Mason D, Kavanaugh A, Smolen J. Efficacy and rapid response of certolizumab pegol liquid formulation in combination with methotrexate (MTX) in patients with active rheumatoid arthritis despite MTX therapy: results from the RAPID 2 study. Program and abstracts of the American College of Rheumatology (ACR) 71st Annual Meeting; 6 ‐ 11 November 2007; Boston, Massachusetts. [Abstract #941]. 2007.
    1. Schiff M, Keininger DL, Tahiri‐Fitzgerald E. Certolizumab pegol added onto methotrexate improves physical functioning and reduces pain in patients with rheumatoid arthritis who have an incomplete response to methotrexate: data from rapid 2. Program and abstracts of the European League Against Rheumatism (EULAR) Annual Meeting; Barcelona, Spain 13 ‐ 16 June [Abstract #0200]. 2007.
Smolen 2015 {published data only}
    1. NCT00674362. Rheumatoid arthritis (RA) moderate to low disease activity study (CERTAIN). clinicaltrials.gov/ct2/show/NCT00674362 (first received 5th May 2008).
    1. Smolen JS, Emery P, Ferraccioli G, Samborski W, Berenbaum F, Davies O, et al. Maintenance of remission in rheumatoid arthritis patients with low‐moderate disease activity following withdrawal of certolizumab PEGOL treatment: Week 52 results from the certain study. Annals of the Rheumatic Disease 2013;71 Suppl 3:361.
    1. Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, Davies OR, et al. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double‐blind, randomised, placebo‐controlled trial. Annals of the Rheumatic Diseases 2015; Vol. 74, issue 5:843‐50. [DOI: 10.1136/annrheumdis-2013-204632] - DOI - PMC - PubMed
    1. Smolen JS, Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, et al. Certolizumab pegol plus methotrexate 5‐year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long‐term extension in rheumatoid arthritis patients. Arthritis Research & Therapy 2015;17:245. - PMC - PubMed
Weinblatt 2012 {published data only}
    1. Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, et al. Impact of certolizumab pegol on patient‐reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Research & Therapy 2015;17:343. - PMC - PubMed
    1. Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford) 2012;51:2204‐14. - PubMed
    1. Weinblatt ME, Fleischmann R, Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, et al. Twenty‐eight‐week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Research & Therapy 2015;17:325. [DOI: 10.1186/s13075-015-0841-9] - DOI - PMC - PubMed
Yamamoto (a) 2014 {unpublished data only}
    1. NCT00791921. Efficacy confirmation trial of CDP870 without coadministration of methotrexate (MTX) in Japanese rheumatoid arthritis (RA). clinicaltrials.gov/show/NCT00791921 (first received 14 November 2008).
    1. NCT00850343. Long‐term treatment study of certolizumab pegol without coadministration of methotrexate in Japanese rheumatoid arthritis (RA) patients. clinicaltrials.gov/ct2/show/NCT00850343?term=NCT00850343&rank=1 (first received 23rd February 2009).
    1. Takeuchi T, Yamamoto K, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Better clinical responses seen early with the loading dose of certolizumab pegol are maintained until one year. Annals of the Rheumatic Diseases.Conference: Annual European Congress of Rheumatology of the European League Against Rheumatism, EULAR 2014 Paris France. 11 ‐ 14 June 2014. 2014; Vol. 73.
    1. Tanaka Y, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Eguchi K, et al. Long‐term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate: 52‐week results from an open‐label extension of the HIKARI study. Modern Rheumatology 2013; Vol. 24, issue 5:725‐33. [DOI: 10.3109/14397595.2013.865822] - DOI - PubMed
    1. Yamamoto, Kazuhiko, Takeuchi, Tsutomu, Yamanaka, Hisashi, et al. Efficacy and safety of certolizumab pegol without methotrexate co‐administration in Japanese patients with active rheumatoid arthritis: The HIKARI randomized, placebo‐controlled trial. Modern Rheumatology 2014;24:552‐560. - PubMed
Yamamoto (b) 2014 {published data only}
    1. NCT00791999. Efficacy confirmation trial of CDP870 as add‐on medication to methotrexate (MTX) in Japanese rheumatoid arthritis (RA). clinicaltrials.gov/ct2/show/study/NCT00791999?term=NCT00791999&rank=1 (first received 14th November 2008).
    1. Takeuchi T, Yamamoto K, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Better clinical responses seen early with the loading dose of certolizumab pegol are maintained until one year. Annals of the Rheumatic Diseases.Conference: Annual European Congress of Rheumatology of the European League Against Rheumatism, EULAR 2014 Paris France. 11 ‐ 14 June 2014. 2014; Vol. 73.
    1. Tanaka Y, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Eguchi K, et al. Long‐term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: 52‐week results from an open‐label extension of the J‐RAPID study. Modern Rheumatology 2014;24(5):734‐43. - PMC - PubMed
    1. Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J‐RAPID randomized, placebo‐controlled trial. Modern Rheumatology 2014;24(5):715‐24. [DOI: 10.3109/14397595.2013.864224] - DOI - PubMed
    1. Yamanaka H, Yamamoto K, Takeuchi T, Ishiguro N, Tanaka Y, Eguchi K, et al. AB0468 Improved physical function, pain, and health related quality of life with certolizumab pegol in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: Results from the JRapid study. Annals of the Rheumatic Diseases 2013;71 Suppl 3:664. [DOI: 10.1136/annrheumdis-2012-eular.468] - DOI
Østergaard 2015 {published data only}
    1. Østergaard M, Axelsen MB, Jacobsson LTH, Schaufelberger C, Hansen MS, Bijlsma JWJ, et al. Dynamic magnetic resonance imaging in the assessment of the response to certolizumab pegol in rheumatoid arthritis patients: Results from a phase IIIB randomized study. Arthritis and Rheumatology.Conference: 2014 ACR/ARHP Annual Meeting Boston, MA United States.Conference Start: 20141114 Conference End: 20141119.Conference Publication: (var.pagings) 2014;66(pp S518‐S519):October.
    1. Østergaard M, Jacobsson LTH, Schaufelberger C, Hansen MS, Bijlsma JWJ, Dudek A, et al. MRI assessment of early response to certolizumab pegol in rheumatoid arthritis: a randomised, double‐blind, placebo‐controlled phase IIIb study applying MRI at weeks 0, 1, 2, 4, 8 and 16. Annals of the Rheumatic Diseases 2015;74(6):1156‐63. - PMC - PubMed

References to studies excluded from this review

Alten 2013 {published and unpublished data}
    1. Alten R, Fleischmann R, Vollenhoven R, Vencovsky J, Davies O, Stach C, et al. Long term tolerability and efficacy of a 4‐week‐administration of certolizumab pegol as monotherapy and combination therapy in rheumatoid arthritis; 5‐year‐data of an open extension study. Zeitschrift Für Rheumatologie 2013;72:111.
Bykerk 2015 {published data only}
    1. Bykerk VP, Bingham C, Burmester G, Furst DE, Mariette X, Purcaru O, et al. Reduction of disease burden on workplace and household productivity following 52 weeks of treatment with certolizumab pegol in combination with methotrexate in DMARD‐naive patients with active, severe, progressive rheumatoid arthritis. Arthritis and Rheumatology.Conference: American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting, ACR/ARHP 2015 San Francisco, CA United States.Conference Start: 20151106 Conference End: 20151111.Confer 2015;67(no pagination):October.
Curtis 2014 {published data only}
    1. Curtis JR, Churchill M, Kivitz A, Samad A, Gauer L, Coteur G, et al. Randomization to patient‐reported RAPID3 versus physician‐based CDAI tools for prediction of treatment response and assessment of patient‐reported outcomes in rheumatoid arthritis patients receiving certolizumab pegol: Results from the predict study. Annals of the Rheumatic Diseases.Conference: Annual European Congress of Rheumatology of the European League Against Rheumatism, EULAR 2014 Paris France. 11 ‐14 June 2014. 2014; Vol. 73.
Curtis 2015a {published data only}
    1. Curtis JR, Churchill M, Kivitz A, Samad A, Gauer L, Gervitz L, et al. A randomized trial comparing disease activity measures for the assessment and prediction of response in rheumatoid arthritis patients initiating certolizumab pegol. Arthritis & Rheumatology 2015;67(12):3104‐12. - PMC - PubMed
Curtis 2015b {published data only}
    1. Curtis JR, Longueville M, O'Brien C, Haraoui B. Improvement in disease activity and the long‐term risk of serious infectious events in rheumatoid arthritis patients treated with certolizumab pegol. Arthritis and Rheumatology.Conference: American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting, ACR/ARHP 2015 San Francisco, CA United States. 6 ‐ 11 November 2015. 2015; Vol. 67.
Dose Flex 2007 {published data only}
    1. Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, et al. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care & Research 2015;67(2):151‐60. - PMC - PubMed
    1. NCT00580840. Dosing flexibility study in patients with rheumatoid arthritis (DoseFlex). clinicaltrials.gov/ct2/show/results/NCT00580840 (first received 21st December 2007).
Fleischmann 2013 {published data only}
    1. Fleischmann R, Vollenhoven R, Vencovsky J, Alten R, Davies O, Stach C, et al. Long‐term safety and efficacy of 4‐weekly certolizumab pegol monotherapy and combination therapy in rheumatoid arthritis: 5‐year results from an open‐label extension study. Annals of the Rheumatic Diseases 2013;72:435.
Kavanaugh 2013 {published data only}
    1. Kavanaugh A, Smolen JS, Emery P, Keystone E, Strand V, Purcaru O, et al. Long‐term benefits over more than 4 years of certolizumab pegol combination therapy on workplace and household productivity, and participation in social activities in rheumatoid arthritis: Results from the open‐label extension study. Value in Health 2013;16:A570.
Kavanaugh 2014 {published data only}
    1. Kavanaugh A, Mease PJ, Strand V, Purcaru O, Curtis JR. PMS66 ‐ Effect of certolizumab pegol on workplace And household productivity In United States patients with rheumatoid arthritis with or without prior anti‐Tnf exposure: results from the Predict study. Value in Health 2014;17(3):A53.
Kivitz 2014 {published data only}
    1. Kivitz AJ, Schechtman J, Texter M, Fichtner A, Longueville M, Chartash EK. Vaccine responses in patients with rheumatoid arthritis treated with certolizumab pegol: results from a single‐blind randomized phase IV trial. Journal of Rheumatology 2014;41(4):648‐57. - PubMed
NCT00160641 {published data only}
    1. NCT00160641. A study of the safety and effectiveness of liquid certolizumab pegol in the treatment of signs and symptoms of rheumatoid arthritis and in prevention of joint damage in patients with active rheumatoid arthritis. clinicaltrials.gov/ct2/show/NCT00160641?term=NCT00160641&rank=1 (first received 8th September 2005).
NCT00160693 {published data only}
    1. NCT00160693. Open label long‐term safety study of certolizumab pegol (CZP) for patients with rheumatoid arthritis. clinicaltrials.gov/ct2/show/NCT00160693 (first received 6th September 2005).
NCT00753454 {published data only}
    1. NCT00753454. Open label extension for patients coming from the dosing flexibility study in patients with rheumatoid arthritis (RA) (Dose Flex II). clinicaltrials.gov/ct2/show/NCT00753454?term=NCT00753454&rank=1 (first received 5th June 2008).
NCT00843778 {published data only}
    1. NCT00843778. Follow‐up of rheumatoid arthritis (RA) moderate to low disease activity study (CERTAIN 2). clinicaltrials.gov/ct2/show/NCT00843778?term=NCT00843778&rank=1 (first received 5th January 2009).
NCT00851318 {published data only}
    1. NCT00851318. Long‐term treatment study of certolizumab pegol (CDP870) as add‐on medication to methotrexate in Japanese rheumatoid arthritis (RA) Patients. clinicaltrials.gov/ct2/show/NCT00851318?term=certolizumab+and+arthritis&... (first received 23rd February 2009).
NCT00993668 {unpublished data only}
    1. NCT00993668. Assessing the use of certolizumab pegol in adult subjects with rheumatoid arthritis on the antibody response when receiving influenza virus and pneumococcal vaccines. clinicaltrials.gov/ct2/show/results/NCT00993668?term=NCT00993668&rank=1 (first received 9th October 2009).
NCT01197066 {published data only}
    1. NCT01197066. Open‐label, extension study of CDP870 in patients with rheumatoid arthritis. clinicaltrials.gov/ct2/show/NCT01197066? (first received 17th March 2010).
NCT01255761 PREDICT {published data only}
    1. NCT01255761. A comparison of two assessment tools in predicting treatment success of cimzia in rheumatoid arthritis subjects (PREDICT). clinicaltrials.gov/ct2/show/NCT01255761?term=NCT01255761&rank=1 (first received 6th December 2010).
NCT01292265 {published data only}
    1. NCT01292265. A 12 week study to assess changes in joint inflammation using ultrasonography in patients with rheumatoid arthritis (RA). clinicaltrials.gov/ct2/show/NCT01292265?term=certolizumab+and+arthritis&... (first received 7th February 2011).
NCT01374971 {published data only}
    1. NCT01374971. Rheumatoid arthritis treatment and biopsy study assessing certolizumab pegol (Cimzia). clinicaltrials.gov/ct2/show/results/NCT01374971?term=NCT01374971&rank=1 (first received 14th June 2011).
NCT01443364 {published data only}
    1. NCT01443364. Open label study to assess the predictability of early response to certolizumab pegol in patients with rheumatoid arthritis (SPEED). clinicaltrials.gov/ct2/show/NCT01443364?term=certolizumab+and+arthritis&... (first received 27th September 2011).
NCT01526434 {published data only}
    1. NCT01526434. Health‐related quality of life and patient‐reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol. clinicaltrials.gov/ct2/show/NCT01526434?term=certolizumab+and+arthritis&... (first received 1st February 2012).
NCT02319642 {published data only}
    1. NCT02319642. An open‐label extension study of certolizumab pegol in Chinese patients with rheumatoid arthritis who enrolled in RA0044 (RAPID‐C OLE). clinicaltrials.gov/ct2/show/NCT02319642?term=certolizumab+and+arthritis&... (first received 15th December 2014).
NCT02586246 {published data only}
    1. NCT02586246. Long‐term treatment study of CDP870 self‐injection in patients with active rheumatoid arthritis who are participating in the long‐term treatment studies (Study 275‐08‐002 or Study 275‐08‐004) of CDP870. clinicaltrials.gov/ct2/show/NCT02586246?term=certolizumab+and+arthritis&... (first received 23rd October 2015).

References to ongoing studies

NCT01295151 {published data only}
    1. NCT01295151. SWITCH clinical trial for patients with rheumatoid arthritis who have failed an initial TNF‐blocking drug (SWITCH). clinicaltrials.gov/ct2/show/NCT01295151 (first received 11th February 2011).
    1. Navarro C, Nuria C, Brown S, Bosworth A, et al. The 'Switch’ study protocol: a randomised‐controlled trial of switching to an alternative tumour‐necrosis factor (TNF)‐inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF‐inhibitor drug. BMC Musculoskeletal Disorders 2014; Vol. 15:452. [DOI: 10.1186/1471-2474-15-452] - DOI - PMC - PubMed
NCT01489384 {published data only}
    1. NCT01489384. Cimzia treatment in rheumatoid arthritis: randomizing to stop versus continue disease‐modifying anti‐rheumatic drug(s). clinicaltrials.gov/ct2/show/NCT01489384?term=certolizumab+and+arthritis&... (first received 7th December 2011).
NCT01491815 {published data only}
    1. NCT01491815. Active conventional therapy compared to three different biologic treatments in early rheumatoid arthritis with subsequent dose reduction. clinicaltrials.gov/ct2/show/NCT01491815?term=certolizumab+and+arthritis&... (first received 8th December 2011).
NCT01500278 {published data only}
    1. NCT01500278. Study to assess the short‐ and long‐term efficacy of certolizumab pegol plus methotrexate compared to adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) inadequately responding to methotrexate. clinicaltrials.gov/ct2/show/NCT01500278?term=certolizumab+and+arthritis&... (first received 22nd December 2011).
NCT01602302 {published data only}
    1. NCT01602302. Ultrasound and withdrawal of biological DMARDs in rheumatoid arthritis. clinicaltrials.gov/ct2/show/NCT01602302?term=certolizumab+and+arthritis&... (first received 16th May 2012).
NCT02151851 {published data only}
    1. NCT02151851. A study of certolizumab pegol as additional therapy in Chinese patients with active rheumatoid arthritis (RAPID‐C). clinicaltrials.gov/ct2/show/NCT02151851?term=certolizumab+and+arthritis&... (first received 28th May 2014).
NCT02293590 {published data only}
    1. NCT02293590. RICE: Remission by Intra‐articular Injection Plus Certolizumab. clinicaltrials.gov/ct2/show/NCT02293590?term=certolizumab+and+arthritis&... (first received 30th October 2014).
NCT02430909 {published data only}
    1. NCT02430909. Multiple dose study of UCB4940 as add‐on to certolizumab pegol in subjects with rheumatoid arthritis. clinicaltrials.gov/ct2/show/NCT02430909?term=certolizumab+and+arthritis&... (first received 27th April 2015).
NCT02466581 {published data only}
    1. NCT02466581. Dose reduction for early rheumatoid arthritis patients with low disease activity. clinicaltrials.gov/ct2/show/NCT02466581?term=certolizumab+and+arthritis&... (first received 29th May 2015).

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References to other published versions of this review

Ruiz Garcia 2009
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