ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1524

Tildrakizumab Efficacy on Psoriasis in Patients with Psoriatic Arthritis—An Analysis from a Phase 2 Study

Alice Gottlieb 1, Ana-Maria Orbai 2, Rocco Ballerini 3, Richard C. Chou 4, Stephen Rozzo 3, Alan Mendelsohn3 and Luis R. Espinoza 5, 1Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York City, NY, 2Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 3Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, 4University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA, Buffalo, NY, 5Section of Rheumatology, LSU Health Sciences Center, New Orleans, LA, New Orleans, LA

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody approved by the FDA to treat moderate-to-severe plaque psoriasis. A randomized, double-blind, multidose, placebo-controlled, phase 2b study (NCT02980692) is underway to evaluate the efficacy and safety of TIL for the treatment of PsA. In this interim analysis of the phase 2b study, the effect of TIL on Psoriasis Area and Severity Index (PASI) 75/90/100 response rates was evaluated in study patients with PsA and measurable psoriasis (≥3% of the body surface area [BSA] affected at baseline).

Methods: Patients ≥18 years of age with active PsA (Classification of Psoriatic Arthritis criteria)1 were stratified by prior anti-TNF use (yes/no) and baseline body weight (≤90 kg and ≥90 kg), and randomized 1:1:1:1:1 to receive TIL (200 mg once every 4 weeks [Q4W], 200 mg every 12 weeks [Q12W], 100 mg Q12W, or 20 mg Q12W to week 24) or placebo (PBO Q4W to week 24).  PASI75/90/100 were prespecified endpoints and assessments were conducted by an independent assessor. Efficacy was analyzed in the full analysis set, defined as all randomized subjects who received ≥1 dose of study drug. Safety assessments included treatment-emergent adverse event (TEAE) monitoring.

Results: Of 500 patients screened, 391 patients met inclusion criteria with 77–79 per treatment arm (TIL 200 mg Q4W, TIL 200 mg Q12W, TIL 100 mg Q12W, and TIL 20 mg Q12W vs PBO) of which, 234 patients had BSA ≥3% at baseline (41–54 per treatment arm, Table 1). Mean age (SD) was 48.8 (12.6), 96.7% white, average body mass index 29.7, and 23.3% were anti–TNF-experienced. At week 24, 61.5%/43.2%/26.0% in combined TIL arms vs 16.7%/7.1%/4.8% in the PBO arm achieved PASI 75/90/100 responses (Figure 1). The most frequent TEAEs included nasopharyngitis (pooled TIL arms 5.4% vs PBO 6.3%) and upper respiratory tract infection (pooled TIL arms 3.5% vs PBO 1.3%). No deaths were reported.

Conclusion: By week 24, TIL significantly improved PASI 75/90/100 in patients with PsA and psoriasis vs PBO. Numerically, 200-mg dosing led to higher PASI 75 and 90 responses by week 24 compared with 100-mg dosing in patients with mild to moderate psoriasis and PsA. Further studies that are powered to compare the 100-mg vs 200-mg dose are needed to confirm this observation. Improvements in skin responses were significant vs PBO as early as week 4 for PASI 75 in the TIL 200 mg Q12W arm. These data provide evidence that TIL significantly improves psoriasis in patients with PsA and is well tolerated in a mixed population of anti–TNF-naïve and -experienced patients.

Editorial and writing support was provided by Marie-Louise Ricketts, PhD, of AlphaBioCom, LLC.

 

References:

  1. Taylor W, et al. Arth Rheum, 2006; 54: 2665-2673.


Table 1_picture

Table 1. Patient demographics and baseline disease characteristics.

*For prior anti-TNF-α therapy, total patients analyzed -N- = 79, 78, 80, 78, and 76 for TIL 200 mg Q4W, TIL 200 mg Q12W, TIL 100 mg, TIL 20 mg, and PBO.
†For prior baseline PASI, total patients analyzed -N- = 75, 79, 76, 75, and 75 for TIL 200 mg Q4W, TIL 200 mg Q12W, TIL 100 mg, TIL 20 mg, and PBO.
Shown for randomized patients who received ≥1 dose of study drug.
BMI, body mass index; BSA, body surface area; PBO, placebo; PsA, psoriatic arthritis; Q4W, every 4 weeks; Q12W, every 12 weeks; SD, standard deviation; TIL, tildrakizumab.

Figure 1. PASI 75/90/100 response rates§

§Response rates calculated in patients with BSA ≥3% at baseline, missing responses were imputed as nonresponses.
*P <0.05; †P <0.001; ‡P <0.0001 vs PBO.
BSA, body surface area; PASI, Psoriasis Area and Severity Index; PBO, placebo; Q4W, every 4 weeks; Q12W, every 12 weeks; TIL, tildrakizumab.

Disclosure: A. Gottlieb, AbbVie, 5, 6, Abbvie, 5, Allergan, 5, 6, Amgen, 8, Avotres Therapeutics, 5, 6, Beiersdorf, 5, 6, Boehringer Ingelheim, 2, 5, 6, Boerhinger Ingelheim, 2, 5, Bristol Myers Squibb Co., 5, Bristol-Myers Squibb, 5, 6, Celgene Corp, 5, Celgene Corp., 5, 6, Dermira, 5, 6, Eli Lilly, 5, 6, 8, 9, Foamix, Incyte, 2, 5, 6, Janssen, 2, 5, 6, 8, Janssen Inc, 2, 5, Leo, 5, LEO, 5, 6, Lily, 5, Merck, Novartis, 2, 5, 6, 8, Ortho Dermatologics, 8, Reddy Labs, 5, 6, Sun Pharmaceutical Industries, 5, Sun Pharmaceutical Industries, Inc., 5, 6, 8, UCB, 2, 5, 6, Valeant, 5, 6, XBiotech, 2, 5, 6, Xbiotech, 2, 5; A. Orbai, AbbVie, 2, Celgene, 2, Eli Lilly, 2, 5, Horizon, 2, Janssen, 2, 5, Lilly, 2, 5, Novartis, 2, 5, Pfizer, 5, UCB, 5; R. Ballerini, Sun Pharmaceutical Industries, Inc., 3; R. Chou, Sun Pharmaceutical Industries, Inc., 5; S. Rozzo, Sun Pharmaceutical Indsutries, Inc, 3, Sun Pharmaceutical Industries, Inc, 3, Sun Pharmaceutical Industries, Inc., 3; A. Mendelsohn, Johnson and Johnson, 1, 4, Sun Pharmaceutical Industries, Inc, 3, Sun Pharmaceutical Industries, Inc., 3; L. Espinoza, None.

To cite this abstract in AMA style:

Gottlieb A, Orbai A, Ballerini R, Chou R, Rozzo S, Mendelsohn A, Espinoza L. Tildrakizumab Efficacy on Psoriasis in Patients with Psoriatic Arthritis—An Analysis from a Phase 2 Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/tildrakizumab-efficacy-on-psoriasis-in-patients-with-psoriatic-arthritis-an-analysis-from-a-phase-2-study/. Accessed .

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