Efficacy and Safety of Neihulizumab (AbGn-168H) in Patients with Active Psoriatic Arthritis: 24-week Results from a Phase II Open Label Study

Stanley Cohen¹, Justus Fiechtner², Philip Mease³, Jeffrey Kaine⁴, Arthur Kavanaugh⁵, Yi-Lin (Irene) Cheng⁶, Claire Chou⁶, Ting-Ying Cheng⁷, Shih-Yao Lin⁶ and Mark Genovese⁸, ¹University of Texas Southwestern Medical School at Dallas, and Metroplex Clinical Research Center, Dallas, TX, ²Michigan State University, Grand Rapids,, MI, ³Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ⁴Sarasota Arthritis Research Center, Sapphire, NC, ⁵UC San Diego Health System, San Diego, CA, ⁶AltruBio, Taipei, Taiwan (Republic of China), ⁷AltruBio, Redwood City, CA, ⁸Stanford University Medical Center, Palo Alto, CA

Meeting: ACR Convergence 2020

Keywords: Apoptosis, Biologicals, clinical trial, Psoriatic arthritis

Session Information

Date: Saturday, November 7, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II

Session Type: Poster Session B

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

Background/Purpose: Neihulizumab is a novel immune checkpoint agonistic antibody that binds to human CD162 (PSGL-1), thereby preferentially inducing apoptosis in late stage activated T cells. It is being tested in putative T-cell mediated inflammatory diseases including ulcerative colitis and graft versus host disease. To assess the efficacy and safety of Neihulizumab in patients with active psoriatic arthritis (PsA) in an open-label 24-week Phase II POC study.

Methods: Twenty (20) patients with active PsA fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) were treated with 3 weekly doses plus 4 bi-weekly doses of 9 mg/kg IV Neihulizumab with follow-up at weeks 12, 16, 20, and 24. The primary endpoint was the proportion of patients achieving an ACR 20 response at Week 12. Safety was assessed throughout the study period.

Results: Twenty patients (20) were enrolled. The majority of the patients were female (12/20, 60.0%) and white (18/20, 90.0%). The median age was 55.5(42-72) years. The median duration of psoriatic arthritis was 4.5 (0.7-30) years. The median duration of psoriasis was 25 (1.9-47) years. Forty (40.0) % (8/20) of patients achieved ACR20 responder status at Week 12 in ITT population by Non-Responder Imputation. At week 12 the ACR50 and 70 response rates were 30%, and 10%, respectively. Analysis by DAS28(CRP) showed concordant result. Durability of ACR20/50/70 was maintained through week 24 for at least 50% of responders after the last treatment at Week 10. Neihulizumab treatment was well tolerated with no deaths, no serious AEs, and no severe AEs observed. The most frequent TEAEs overall (including the treatment period and follow-up period) were urinary tract infection (15.0%), psoriatic arthropathy (15.0%), headache (10.0%), sinus congestion (10.0%), and hematoma (10.0%).

Conclusion: Overall treatment of Neihulizumab was well tolerated in this study. Improvement was seen in efficacy parameters, suggesting there may be clinical utility with this novel agent for the treatment of psoriatic arthritis. Controlled studies are indicated

ClinicalTrials.gov Identifier: NCT02267642

Disclosure: S. Cohen, Abbvie, 2, 5, Pfizer, 2, 5, Gilead, 2, 5, Lilly, 2, 5; J. Fiechtner, None; P. Mease, Amgen, 2, 5, 8, Bristol-Myers Squibb, 2, 5, Novartis, 2, 5, 8, Pfizer Inc, 2, 5, 8, Sun, 2, 5, UCB, 2, 5, 8, AbbVie, 2, 5, 8, Gilead, 2, 5, Janssen, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, GlaxoSmithKline, 5; J. Kaine, None; A. Kavanaugh, Eli Lilly and Company, 5; Y. Cheng, None; C. Chou, AltruBio Inc., 3; T. Cheng, None; S. Lin, AltruBio, 1, 3; M. Genovese, Abbvie, 2, 5, Eli Lilly and Company, 2, 5, Galapagos, 2, 5, Gilead Sciences Inc., 2, 5, Pfizer, 2, 5, EMD Merck Serono, 2, 5, Genentech/Roche, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, RPharm, 2, 5, Sanofi-Genzyme, 2, UCB, 5, Amgen, 5.

To cite this abstract in AMA style:

Cohen S, Fiechtner J, Mease P, Kaine J, Kavanaugh A, Cheng Y, Chou C, Cheng T, Lin S, Genovese M. Efficacy and Safety of Neihulizumab (AbGn-168H) in Patients with Active Psoriatic Arthritis: 24-week Results from a Phase II Open Label Study [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-neihulizumab-abgn-168h-in-patients-with-active-psoriatic-arthritis-24-week-results-from-a-phase-ii-open-label-study/. Accessed .

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