The Efficacy of Certolizumab Pegol over 4 Years in Psoriatic Arthritis Patients With and Without Concomitant Use of DMARDs
O. FitzGerald (1), J. Walsh (2), A. B. Gottlieb (3), B. Hoepken (4), T. Nurminen (4), P. J. Mease (5)
1. St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; 2. Division of Rheumatology, University of Utah, UT, USA; 3. Department of Dermatology, New York Medical College, NY, USA; 4. UCB Pharma, Monheim, Germany; 5. Swedish Medical Center and University of Washington, WA, USA.
In RAPID-PsA (NCT01087788) certolizumab pegol (CZP) improved signs and symptoms of psoriatic arthritis (PsA) over 4-years' treatment.
Here we report short- and long-term efficacy of CZP with and without concomitant DMARD use, including effects on extra-articular manifestations of the disease (EAMs).
RAPID-PsA was double-blind and placebo-controlled to Week (Wk)24, dose-blind to Wk48 and open-label (OL) to Wk216. Patients (pts) had active PsA with ≥1 failed DMARD. Wk0 CZP-randomized pts (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued their assigned dose in OL. We report efficacy to Wk216 for pts receiving CZP from Wk0 (dose combined) with and without DMARD use at baseline (BL; DMARD+ and DMARD-). Outcomes included ACR20, Psoriasis Area Severity Index (PASI), Leeds Enthesitis Index (LEI), and Leeds Dactylitis Index (LDI) in pts with involvement of the respective EAM at BL (psoriasis: BSA ≥3%; enthesitis: LEI >0; dactylitis: ≥1 digit affected and LDI ≥0). Data are observed case (OC) and imputed: NRI for dichotomous outcomes and LOCF for quantitative data.
273 pts received CZP from Wk0. 74 (27.1%) CZP pts were DMARD-, 6 (8.1%) of whom initiated a new DMARD during the study. 8 DMARD+ pts (4.0%) increased, 29 (14.6%) reduced/discontinued and 13 (6.5%) increased and reduced/discontinued DMARD use. 141 (70.9%) DMARD+ and 42 (56.8%) DMARD- pts completed Wk216. Efficacy of CZP in both DMARD+ and DMARD- pts was maintained over 4 years (NRI [OC]: DMARD+: ACR20 at Wk24=62.8%, at Wk216=57.3% [79.7%]; DMARD-: ACR20 at Wk24=52.7%, at Wk216=47.3% [83.3%]). Among DMARD+ and DMARD- pts, at BL, 113 and 53 (56.8%; 71.6%) had psoriasis (mean PASI=11.4; 13.3), 125 and 47 (62.8%; 63.5%) enthesitis (mean LEI=3.1; 2.7), and 47 and 20 (23.6%; 27.0%) dactylitis (mean LDI=54.3; 59.7). Improvements in EAMs at Wk24 were maintained to Wk216 in both DMARD+ and DMARD- pts (imputed [OC]: DMARD+ pts: mean PASI at Wk24=2.6, at Wk216=2.3 [1.7]; PASI75 at Wk24=57.5%, at Wk216=54.0% [79.2%]; mean LEI at Wk24=1.0, at Wk216=0.8 [0.6]; mean LDI at Wk24=3.7, at Wk216=4.3 [0.4]; DMARD- pts: mean PASI at Wk24=2.9, at Wk216=3.2 [2.2]; PASI75 at Wk24=69.8%, at Wk216=47.2% [78.1%]; mean LEI at Wk24=1.0, at Wk216=0.9 [0.2]; mean LDI at Wk24=5.7, at Wk216=3.7 [2.5]).
Pts completing RAPID-PsA, treated with CZP both with and without concomitant DMARD use, showed sustained improvements in their disease, maintained over 4 years.