The effect of certolizumab pegol on skin manifestations of psoriatic arthritis over 4 years of treatment in patients with and without prior anti-TNF exposure

Background: In the RAPID-PsA trial (NCT01087788), certolizumab pegol (CZP) improved skin manifestations of psoriatic arthritis (PsA) over 96 weeks (wks). Here we report dermatologic outcomes over 4 years' of CZP treatment in patients (pts) with and without prior anti-TNF exposure. Methods: RAPID-PsA 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;≤40% of pts could have received 1 prior anti-TNF. Pts randomized to CZP at baseline (BL; 200mg Q2Wor 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued their assigned dose in the OL period. The primary clinical outcome (ACR20 at Wk12) has been reported previously. We report dermatologic outcomes for CZP-randomized pts with ≥3% skin involvement at BL, for pts with and without prior anti-TNF exposure. Data are reported as observed case (OC) and with imputation: NRI for categorical outcomes, LOCF for continuous measures. Results: 273/409 randomized pts received CZP from Wk0; of these, 183 (67.0%) completed Wk216. The primary clinical variable showed relevant differences (Wk12 ACR20: 58.0%, 51.9% vs 24.3% for CZP 200mg Q2W, 400mg Q4W vs placebo [NRI]). ACR responses were maintained to Wk216 (ACR20: 54.3%, 54.8% for CZP 200mg Q4W, 400mg Q4W [NRI]). Of 166 pts with≥3% skin involvement at BL, 36 pts across CZP dose groups had prior anti-TNF exposure (mean PASI=11.8, meanDLQI=11.7), 130 were anti-TNF naïve (mean PASI = 12.1, mean DLQI = 11.1). Improvements in PASI responses observed to Wk96 were sustained to Wk216, both in pts with and without prior anti-TNF exposure (PASI75 with vs without prior anti

-TNF:

Wk96 = 69.2% vs 74.0%, Wk216 = 90.9% vs 75.9%). Improvements were maintained even when stringent NRI imputation was used (PASI75 with vs without prior anti

-TNF:

Wk96 = 50.0% vs 54.6%, Wk216 = 55.6% vs 50.8%). Similar sustained improvements occurred in mean PASI score (OC: with vs without prior anti

-TNF:

Wk96= 2.4 vs 1.7, Wk216 = 1.3 vs 2.0; LOCF imputed: with vs without prior anti

-TNF:

Wk96 = 2.4 vs 2.6, Wk216 = 2.4 vs 2.6), and the patient-reported measure DLQI (OC: mean with vs without prior anti

-TNF:

Wk96= 1.8 vs 3.2, Wk216=2.1 vs 3.1; LOCF imputed: mean with vs without prior anti

-TNF:

Wk96 = 2.9 vs 3.5, Wk216 = 3.5 vs 3.6). Conclusion: Improvements in joint and skin manifestations of PsA were maintained over 4 years' of CZP treatment. Skin outcomes were maintained in pts with and without prior anti-TNF exposure.