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Evidence summaries

Certolizumab Pegol for Rheumatoid Arthritis in Adults

Certolizumab pegol alone or combined with methotrexate is more effective than placebo (with or without methotrexate) in the treatment of rheumatoid arthritis. Adverse events are more frequent with certolizumab. Level of evidence: "A"

A Cochrane review [Abstract] 1 included studies. Twelve studies (n=5 422) included measures of benefit, and 11 of them were pooled. Thirteen studies included information on harms (n=5 273). The duration of follow-up was from 12 to 52 weeks and the range of doses of certolizumab pegol varied from 50 to 400 mg given subcutaneously (sc). In phase III trials, the control was placebo plus methotrexate (MTX) in 7 studies and placebo in 5 studies. In the 2 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 (table T1):American College of Rheumatology (ACR) 50% improvement (pain, function and other symptoms of RA), The Health Assessment Questionnaire (HAQ; scale 0 to 3, lower scores mean better function), proportion of participants achieving remission (Disease Activity Score (DAS) < 2.6), and radiological changes: erosion score (ES; not a clinically important difference). Serious adverse events (SAEs) were statistically but not clinically significantly more frequent for certolizumab pegol.There was a clinically significant increase in all withdrawals in the placebo groups (for all doses and at all follow-ups), 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).

Certolizumab pegol 200 mg sc (with or without MTX) versus placebo (with or without MTX) for rheumatoid arthritis in adults

OutcomeRelative effect (95% CI)Assumed risk - controlCorresponding risk - intervention (95% CI)Participants (studies)NNT/NNTH
*All doses of certolizumab pegol vs placebo
ACR = American College of Rheumatology; HAQ = Health Assessment Questionnaire; DAS = Disease Activity Score
ACR 50% improvementRR 3.80(2.42 to 5.95)87 per 1000359 per 1000(328 to 391)1 445(5 studies)4 (3 to 5)
HAQ change from baselineScale from: 0 to 3MD -0.35 (-0.43 to -0.26)The mean HAQ change from baseline in the control groups was-0.13The mean HAQ change from baseline in the intervention groups was0.35 lower(0.43 to 0.26 lower)1 268(4 studies)8 (7 to 11)
Proportion of patients achieving DAS <2.6 (remission)RR 2.94(1.64 to 5.28)123 per 1000216 per 1000(194 to 247)2 420(6 studies)8 (6 to 12)
Radiological changes: Erosion Scores (scale from 0 to 230).MD -0.67 (-0.96 to -0.38)The mean radiological changes: Erosion Scores (ES) in the control groups was0.7The mean Radiological changes: Erosion Scores (ES) in the intervention groups was0.67 lower(0.96 to 0.38 lower)714(2 studies)6 (4 to 10)
All Withdrawals*RR 0.47(0.39 to 0.56)524 per 1000231 per 1000(203 to 291)5 200(13 studies)3 (2 to 6)
Withdrawals due to adverse events*Peto OR 1.45 (1.09 to 1.94)38 per 100052 per 1000(40 to 73)5 236(12 studies)58 (28 to 329)
Serious adverse eventsPeto OR 1.47(1.13 to 1.91)58 per 100085 per 1000(59 to 120)3 927(9 studies)33 (25 to 100)

Clinical comment: A potential risk of serious adverse events, including hypertension and tuberculosis in susceptible individuals, needs to be borne in mind when considering certolizumab pegol.

    References

    • Ruiz Garcia V, Burls A, Cabello JB et al. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults. Cochrane Database Syst Rev 2017;(9):CD007649. [PubMed].

Primary/Secondary Keywords