Certolizumab pegol (CDP870) for rheumatoid arthritis in adults

García, Vicente Ruiz; Jobanputra, Paresh; Burls, Amanda; Cabello, Juan B; Vela-Casasempere, Paloma; Bort-Marti, Sylvia; Kynaston-Pearson, Francis JB

doi:10.1002/14651858.cd007649.pub3

Cited by 16 publications

(5 citation statements)

References 94 publications

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“…More recent meta-analyses of clinical trials found no increased overall risk of malignancies with anti-TNF mAbs [107,108] but confirmed the increased risk of serious infections [108]. A non-significant relationship between dose and serious infection was apparent for golimumab [109], rituximab [110,111], and tocilizumab [112], but not for certolizumab pegol [113]. A marginally significant lower risk of infusion reactions within 24 h of the first infusion was described for low-dose compared with high-dose rituximab in RA [112].…”

Section: Dose-adverse-effect Relationshipsmentioning

confidence: 98%

Clinical Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies Approved to Treat Rheumatoid Arthritis

et al. 2015

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Monoclonal antibodies (mAbs) are increasingly used to treat rheumatoid arthritis (RA). At present, anti-tumor necrosis factor-α drugs (infliximab, adalimumab, certolizumab pegol, and golimumab), rituximab, and tocilizumab are approved for RA treatment. This review focuses on the pharmacokinetics and pharmacodynamics of mAbs approved in RA. Being large proteins, mAbs exhibit complex pharmacokinetic and pharmacodynamic properties. In particular, owing to the interactions of mAbs with their antigenic targets, the pharmacokinetics of mAbs depends on target turnover and exhibits non-specific (linear) and target-mediated (often nonlinear) clearances. Their volume of distribution is low (3-4 L) and their elimination half-life usually ranges from 2 to 3 weeks. The inter-individual pharmacokinetic variability of mAbs is usually large and is partly explained by differences in antigenic burden or by anti-drug antibodies, which accelerate mAb elimination. The inter-individual variability of clinical response is large and influenced by the pharmacokinetics. The analysis of mAbs concentration-effect relationship relies more and more often on pharmacokinetic-pharmacodynamic modeling; these models being suitable for dosing optimization. Even if adverse effects of mAbs used in RA are well known, the relationship between mAb concentration and adverse effects is poorly documented, especially for anti-tumor necrosis factor-α mAbs. Overall, RA patients treated with mAbs should benefit from individualized dosing strategies. Because of the complexity of their pharmacokinetics and mechanisms of action, the current dosing strategy of mAbs is not based on sound knowledge. New studies are needed to assess individual dosing regimen, adjusted notably to disease activity.

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Section: Dose-adverse-effect Relationshipsmentioning

confidence: 98%

Clinical Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies Approved to Treat Rheumatoid Arthritis

et al. 2015

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“…Acute exacerbation of pre-existing RA-ILD has been reported after the induction of anti-TNF- therapies, although that during therapy with CZP, a pegylated human anti-TNF-α monoclonal antibody, is rare and has not been reported in the clinical trials of this drug [7].…”

Section: Discussionmentioning

confidence: 99%

“…Certolizumab pegol (CZP) is a pegylated human anti-TNF-α monoclonal antibody and is different from TNF-α inhibitors [6]. Clinical trials have revealed CZP to be effective in the treatment of RA with or without methotrexate (MTX) [7]. Here we report the first case, as per our knowledge, of acute exacerbation of RA-ILD with NLRP3 inflammasome activation in an elderly Japanese woman undergoing CZP maintenance therapy.…”

Section: Introductionmentioning

confidence: 90%

Acute exacerbation of rheumatoid interstitial lung disease during the maintenance therapy with certolizumab pegol

Migita

Tsuji

Hisatomi

et al. 2015

Modern Rheumatology

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We report a case involving a 68-year-old woman with rheumatoid arthritis (RA) with acute exacerbated interstitial lung disease (ILD) during certolizumab pegol maintenance therapy. She recovered quickly with steroid pulse therapy and was discharged without deterioration of basal pulmonary function. Immunoblot analysis demonstrated the circulating cleaved interleukin-1β at the phase of acute exacerbation of RA-associated ILD (RA-ILD) in this patient. The findings from this case suggested that the Nod-like receptor pyrin domain-containing protein 3 inflammasome is implicated in acute RA-ILD exacerbation.

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“…In RA, a Cochrane systematic review of five RCTs comparing certolizumab to placebo or MTX confirmed improvement with certolizumab pegol [62]. A systematic review of four RCTs of golimumab in RA found that compared with patients treated with placebo and MTX, patients treated with golimumab and MTX were 2.6 times more likely to reach ACR 50 at an average of 4-6 months [63].…”

Section: Othermentioning

confidence: 99%