Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA).

Abstract

OBJECTIVES:

To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-PsA (NCT01087788), an ongoing Phase 3 trial in patients with psoriatic arthritis (PsA).

METHODS:

Patients were randomised 1:1:1 to placebo, 200 mg CZP every 2 weeks (Q2W) or 400 mg CZP every 4 weeks (Q4W). Patients could have had exposure to one previous tumour necrosis factor (TNF) inhibitor therapy. Primary endpoints were American College of Rheumatology 20% (ACR20) response at week 12 and modified Total Sharp Score change from baseline at week 24. Secondary endpoints included; Psoriatic Arthritis Response Criteria (PsARC) score, Health Assessment Questionnaire Disability Index (HAQ-DI), Psoriasis Area and Severity Index, Leeds Enthesitis Index, Leeds Dactylitis Index, and Modified Nail Psoriasis Severity Index.

RESULTS:

Of 409 patients randomised, 368 completed 24 weeks of treatment. ACR20 response was significantly greater in CZP 200 mg Q2W and 400 mg Q4W-treated patients than placebo (58.0% and 51.9% vs 24.3% (p<0.001)) at week 12, with improvements observed by week 1. There was a statistically significant improvement in physical function from baseline, measured by HAQ-DI in CZP patients compared with placebo (-0.50 vs -0.19, p<0.001) and more patients treated with CZP 200 mg Q2W and CZP 400 mg achieved an improvement in PsARC at week 24 than placebo (78.3% and 77.0% vs 33.1% (p<0.001)). Sustained improvements were observed in psoriatic skin involvement, enthesitis, dactylitis and nail disease. Higher ACR20 response with CZP was independent of prior TNF inhibitor exposure. No new safety signals were observed.

CONCLUSIONS:

Rapid improvements in the signs and symptoms of PsA, including joints, skin, enthesitis, dactylitis and nail disease were observed across both CZP dosing regimens.

• Authors: P J Mease, R Fleischmann, A A Deodhar, J Wollenhaupt, M Khraishi, D Kielar, F Woltering, C Stach, B Hoepken, T Arledge, D van der Heijde
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 73 Issue 1 Pg. 48-55 (Jan 2014) ISSN: 1468-2060 [Electronic] England
• PMID: 23942868 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Immunoglobulin Fab Fragments
• Immunosuppressive Agents
• Placebos
• Polyethylene Glycols
• Certolizumab Pegol

Topics

• Adult
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects)
• Arthritis, Psoriatic (diagnosis, drug therapy)
• Certolizumab Pegol
• Double-Blind Method
• Female
• Humans
• Immunoglobulin Fab Fragments (administration & dosage, adverse effects)
• Immunosuppressive Agents (administration & dosage, adverse effects)
• Male
• Middle Aged
• Placebos
• Polyethylene Glycols (administration & dosage, adverse effects)
• Treatment Outcome