Background Previous reports of RAPID-PsA (NCT01087788) have demonstrated the clinical efficacy of certolizumab pegol (CZP) in patients (pts) with psoriatic arthritis (PsA) over 96 weeks (wks), but have not yet investigated the long-term improvements in extra-articular manifestations (EAMs) of PsA.1
Objectives To report the efficacy of CZP for the treatment of EAMs in PsA including nail psoriasis, enthesitis, dactylitis, and psoriasis, over 96 wks of the RAPID-PsA trial.
Methods RAPID-PsA1 was double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts were randomized 1:1:1 to either PBO or CZP 400mg loading dose at Wks 0, 2, 4 followed by 200mg Q2W or 400mg Q4W. We present efficacy data for all pts originally randomized to CZP. The primary clinical endpoint was Wk12 ACR20 response.2 EAMs were assessed in pts with baseline (BL) involvement and included nail psoriasis (modified nail psoriasis severity index [mNAPSI], BL involvement = BL mNAPSI >0; for some pts the nail analyzed was changed once or more to Wk96), enthesitis (Leeds enthesitis index [LEI], BL involvement = BL LEI >0), dactylitis (Leeds dactylitis index [LDI], BL involvement = at least 1 digit affected and with a difference in circumference ≥10%) and psoriasis (body surface area affected [BSA], BL involvement = BL BSA ≥3%). We also present data for pts with total resolution of each EAM, ie. the percentage of pts with BL involvement achieving complete clearance (a score of 0 for mNAPSI, LEI or LDI, or 0% BSA). Data shown are observed values.
Results Of 409 pts randomized, 273 received CZP from Wk0. At BL, 197 of these pts had nail psoriasis, 172 enthesitis, 73 dactylitis and 166 psoriasis. Rapid reductions in scores were seen in all EAMs assessed and were maintained to Wk96 of the study. Improvements were observed in nail psoriasis, enthesitis, dactylitis and psoriasis, for pts with BL involvement (Table). These improvements were observed in pts treated with either CZP dose regimen. A large proportion of pts with BL EAM involvement went on to achieve total resolution. For pts with nail psoriasis at BL, 38.5% had achieved total resolution at Wk24 and 65.2% at Wk96. Similar results were seen for pts with enthesitis, dactylitis, or psoriasis at BL (pts with enthesitis at BL achieving total resolution: 65.2% at Wk24 and 71.0% at Wk96; pts with dactylitis at BL achieving total resolution: 73.8% at Wk24 and 89.5% at Wk96; pts with psoriasis at BL achieving total resolution: 26.8% at Wk24 and 48.5% at Wk96).
Conclusions Improvements in EAMs of PsA were observed following CZP treatment and were maintained to Wk96 of RAPID-PsA. These improvements were seen in all EAMs measured, including nail psoriasis, enthesitis, dactylitis and psoriasis. Similar improvements were observed with both CZP dose regimens.
Mease P. J. Ann Rheum Dis 2014;73(S2):90.
Mease P. J. Arthritis Rheum 2013;65(10):S132–133
Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance, which was funded by UCB Pharma.
Disclosure of Interest O. FitzGerald Grant/research support from: Abbvie, Roche, MSD, BMS, Speakers bureau: Janssen, Pfizer, Abbvie, UCB Pharma, Cellgene, R. Fleischmann: None declared, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. Gladman Consultant for: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma