TBA (17A167)

The Effect of Certolizumab Pegol on Extra-Articular Manifestations of Psoriatic Arthritis Over 4 Years of Treatment in Patients With and Without Prior Anti-TNF Exposure

Author(s)

O. FitzGerald (1), R. Fleischmann (2), A. Kavanaugh (3), B. Hoepken (4), L. Peterson (5), D. Gladman (6)

Department(s)/Institutions

1. St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, 2. UT Southwestern Medical Center and Dallas Metroplex Clinical Research Center, Dallas, 3. UC San Diego School of Medicine, La Jolla, United States, 4. UCB Pharma, Monheim, Germany, 5. UCB Pharma, Raleigh, United States, 6. Krembil Research Institute, Toronto Western Hospital, Toronto, Canada

Introduction

Extra-articular manifestations (EAMs) of psoriatic arthritis (PsA) include nail psoriasis, dactylitis, and enthesitis, which can significantly impact patients’ (pts') quality of life. In the RAPID-PsA trial (NCT01087788), certolizumab pegol (CZP) improved the signs and symptoms of EAMs in pts with PsA over 96 weeks (wks).

Aims/Background

To report improvements in EAMs of PsA in pts treated with CZP over 4 years, both with and without prior anti-TNF exposure.

Method

The RAPID-PsA trial was double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label (OL) to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks0, 2, 4) continued their assigned dose in the OL period. We present EAM data for those pts originally randomized to CZP, with involvement of the particular EAM at baseline (BL), and both with and without prior anti-TNF exposure. EAMs assessed include nail psoriasis (modified Nail Psoriasis Severity Index [mNAPSI], BL involvement = BL mNAPSI >0), enthesitis (Leeds Enthesitis Index [LEI], BL involvement = BL LEI >0), and dactylitis (Leeds Dactylitis Index [LDI], BL involvement = ≥1 digit affected with a difference in circumference ≥10% compared to the opposite digit). Also presented are the proportions of pts with BL involvement of each EAM who achieved total resolution of the respective EAM on follow-up (a score of 0 for mNAPSI, LEI, or LDI). Observed values are reported, combined for pts receiving either CZP dose regimen.

Results

A total of 409 PsA pts were randomized; 273 received CZP from Wk0. Among CZP-randomized pts, 197 had nail psoriasis at BL (159 without, and 38 with, prior anti-TNF exposure), 172 had enthesitis (133 without, and 39 with, prior anti-TNF exposure), and 73 had dactylitis (56 without, and 17 with, prior anti-TNF exposure). Although relatively few pts were anti-TNF experienced, a large proportion of pts both with and without prior anti-TNF exposure with BL involvement went on to achieve total resolution of the respective EAM following 48 wks of CZP treatment (Table). Among pts completing the study, the proportions achieving total resolution were maintained or further increased from Wk48 to Wk216 (Table). Mean scores of all EAMs assessed showed improvements by Wk48 of CZP treatment in pts both with and without prior anti-TNF exposure, which were maintained to Wk216 in pts completing the study (Table).

Conclusions

PsA patients treated with CZP for up to 4 years, both with and without prior anti-TNF exposure, exhibited sustained improvements in the extra-articular manifestations of PsA.