4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis

Désirée Van Der Heijde, Atul Deodhar, Oliver Fitzgerald, Roy Fleischmann, Dafna Gladman, Alice B. Gottlieb, Bengt Hoepken, Lars Bauer, Oscar Irvin-Sellers, Majed Khraishi, Luke Peterson, Anthony Turkiewicz, Jürgen Wollenhaupt, Philip J. Mease

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Abstract

Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years' certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years' treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.

LanguageEnglish (US)
Article numbere000582
JournalRMD Open
Volume4
Issue number1
DOIs
StatePublished - Jan 1 2018

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Psoriatic Arthritis
Randomized Controlled Trials
Placebos
Safety
Psoriasis
Tumor Necrosis Factor-alpha
Observation
Certolizumab Pegol
Nails

Keywords

  • anti-TNF
  • dmards (biologic)
  • psoriatic arthritis
  • TNF-alpha

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Van Der Heijde, D., Deodhar, A., Fitzgerald, O., Fleischmann, R., Gladman, D., Gottlieb, A. B., ... Mease, P. J. (2018). 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open, 4(1), [e000582]. https://doi.org/10.1136/rmdopen-2017-000582

4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. / Van Der Heijde, Désirée; Deodhar, Atul; Fitzgerald, Oliver; Fleischmann, Roy; Gladman, Dafna; Gottlieb, Alice B.; Hoepken, Bengt; Bauer, Lars; Irvin-Sellers, Oscar; Khraishi, Majed; Peterson, Luke; Turkiewicz, Anthony; Wollenhaupt, Jürgen; Mease, Philip J.

In: RMD Open, Vol. 4, No. 1, e000582, 01.01.2018.

Research output: Contribution to journalArticle

Van Der Heijde, D, Deodhar, A, Fitzgerald, O, Fleischmann, R, Gladman, D, Gottlieb, AB, Hoepken, B, Bauer, L, Irvin-Sellers, O, Khraishi, M, Peterson, L, Turkiewicz, A, Wollenhaupt, J & Mease, PJ 2018, '4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis' RMD Open, vol. 4, no. 1, e000582. https://doi.org/10.1136/rmdopen-2017-000582
Van Der Heijde, Désirée ; Deodhar, Atul ; Fitzgerald, Oliver ; Fleischmann, Roy ; Gladman, Dafna ; Gottlieb, Alice B. ; Hoepken, Bengt ; Bauer, Lars ; Irvin-Sellers, Oscar ; Khraishi, Majed ; Peterson, Luke ; Turkiewicz, Anthony ; Wollenhaupt, Jürgen ; Mease, Philip J. / 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. In: RMD Open. 2018 ; Vol. 4, No. 1.
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abstract = "Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years' certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20{\%} (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67{\%} (183/273) completed 216 weeks. By Week 48, 60.4{\%} of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3{\%} achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2{\%} of patients achieved minimal disease activity (NRI). 75{\%} reduction in Psoriasis Area and Severity Index responses were 65{\%} and 52{\%} at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71{\%}, 81{\%} and 65{\%}, respectively (LOCF). Structural damage progression was low over 4 years' treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.",
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T1 - 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis

AU - Van Der Heijde, Désirée

AU - Deodhar, Atul

AU - Fitzgerald, Oliver

AU - Fleischmann, Roy

AU - Gladman, Dafna

AU - Gottlieb, Alice B.

AU - Hoepken, Bengt

AU - Bauer, Lars

AU - Irvin-Sellers, Oscar

AU - Khraishi, Majed

AU - Peterson, Luke

AU - Turkiewicz, Anthony

AU - Wollenhaupt, Jürgen

AU - Mease, Philip J.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years' certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years' treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.

AB - Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years' certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years' treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.

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