ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1336

Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19-Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis

Iain McInnes1, Proton Rahman2, Alice Gottlieb3, Elizabeth Hsia4, Alexa Kollmeier5, Xie Xu4, Shihong Sheng4, Yusang Jiang4, May Shawi6, Soumya Chakravarty7, Désirée van der Heijde8 and Philip Mease9, 1University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, 2Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 3Icahn School of Medicine at Mount Sinai, New York, NY, 4Janssen Research & Development, LLC, Spring House, PA, 5Janssen Research & Development, LLC, La Jolla, CA, 6Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, 7Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, 8Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, 9Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA

Meeting: ACR Convergence 2021

Keywords:

Session Information

Date: Monday, November 8, 2021

Session Title: Spondyloarthritis Including PsA – Treatment Poster II: Psoriatic Arthritis I (1329–1363)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Guselkumab (GUS), an anti-IL-23p19-subunit mAb dosed every 4 or 8 weeks (Q4W or Q8W), demonstrated efficacy for joint and skin symptoms, inhibition of structural damage progression (Q4W), and safety vs placebo (PBO) through Week (W) 24 of phase 3, double-blind, PBO-controlled trial in biologic-naïve patients with PsA (DISCOVER-2).1 Favorable benefit-risk was also seen through 1 year.2 This study assessed GUS efficacy and safety through 2 years.

Methods: Biologic-naïve adults with active PsA (≥5 swollen joint count [SJC] + ≥5 tender joint count [TJC]; CRP ≥0.6 mg/dL) were randomized (1:1:1) to GUS 100 mg Q4W; GUS 100 mg at W0, W4, Q8W; or PBO with crossover to GUS 100 mg Q4W (PBO→Q4W) at W24. Clinical efficacy (ACR/PASI/IGA/HAQ-DI) was assessed in the modified intention to treat (mITT) population through W100 with missing data imputation (nonresponse for categorical endpoints; no change/multiple imputation for continuous endpoints). Observed PsA-modified van der Heijde Sharp (vdH-S) scores derived from blinded radiographic images collected at W0, W24, W52, W100 (or at discontinuation [d/c]) and adverse events (AEs) through W112 were collected.

Results: 712/739 (96%) randomized patients continued study agent at W24; 687/739 (93%) continued at W52; 652/739 (88%) completed W100. ACR20 response rates in the mITT population continued to increase after W24, and at W100 were 76% for Q4W and 74% for Q8W (Fig). Similar response patterns were seen for ACR50/70, HAQ-DI and PASI90/100 (Table), and IGA0/1 and PASI75 response rates were consistent through W100 in patients randomized to Q4W and Q8W; W100 data for PBO→Q4W patients were consistent with patients treated with Q4W and Q8W (Table). GUS improvements in SF-36 PCS/MCS at W52 also persisted through W100 (data not shown). Low rates of radiographic progression (as measured by PsA-modified vdH-S scores) were observed during W52-W100 for Q4W (n=227; 0.75) and Q8W (n=232; 0.46). In the PBO→Q4W group (n=228), radiographic progression was 1.12 during W0-W24 (while on PBO), 0.51 during W24-W100 (while on Q4W), and 0.13 during W52-W100. Through W112, the incidences of AEs, serious AEs (SAEs), AEs leading to d/c, infections, serious infections, and injection site reactions were generally consistent with the PBO-controlled period and through 1 year. Of the patients in Q4W (n=245), Q8W (n=248), and PBO→Q4W (n=238) groups, 9%, 9% and 7% had ≥1 SAE; 2%, 3% and 3% had ≥1 serious infection; 2 Q8W patients (fungal esophagitis, disseminated herpes zoster) and 1 PBO→Q4W patient (listeria meningitis) had opportunistic infections; 1 PBO→Q4W patient died (road traffic accident); 1 PBO-randomized patient had IBD; no patient had anaphylactic or serum sickness reaction, or active TB.

Conclusion: In biologic-naïve PsA patients, GUS improvements in joint and skin symptoms, physical function, and low rates of radiographic progression persisted through 2 years. GUS safety in PsA through 2 years was comparable with safety at 6 months and 1 year, similar between Q4W and Q8W, and consistent with GUS safety in psoriasis.

Reference:
1Mease PJ. Lancet. 2020;395:1126-36.
2McInnes IB. Arthritis Rheumatol. 2021;73:604-616.

Disclosures: I. McInnes, Bristol Myers Squibb, 2, 5, Celgene, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Novartis, 2, 5, UCB, 2, 5, Gilead, 2, AbbVie, 2, AstraZeneca, 5, Boehringer Ingelheim, 2, Amgen, 2, 5, 6, Pfizer, 2, 5, 6; P. Rahman, Janssen, 2, 5, 6, Novartis, 2, 5, 6, AbbVie, 2, 6, Amgen, 2, 6, Bristol Myers Squibb, 2, 6, Celgene, 2, 6, Eli Lilly, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Merck, 2, 6; A. Gottlieb, Boehringer Ingelheim, 1, 2, 5, Incyte, 1, 2, 5, Janssen, 1, 2, 5, Novartis, 1, 2, 5, UCB, 1, 2, 5, Xbiotech, 1, 2, 5, Bristol Myers Squibb, 1, 2, LEO Pharma, 1, 2, AnaptysBio, 1, 2, Avotres, 1, 2, Eli Lilly, 1, 2, Pfizer, 1, 2, Beiersdorf, 1, 2, Sun Pharmaceuticals, 1, 2, 5, Dermavant, 1, 2, GlaxoSmithKline, 1, 2; E. Hsia, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; A. Kollmeier, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; X. Xu, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; S. Sheng, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; Y. Jiang, Cytel, Inc., providing statistical support (funded by Janssen), 3; M. Shawi, Janssen Global Services, LLC (a subsidiary of Johnson & Johnson), 3, 11; S. Chakravarty, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; D. van der Heijde, AbbVie, 2, Amgen, 2, Astellas, 2, AstraZeneca, 2, Bayer, 2, BMS, 2, Boehringer Ingelheim, 2, Celgene, 2, Cyxone, 2, Daiichi, 2, Eisai, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Janssen, 2, Merck, 2, Novartis, 2, Pfizer, 2, Regeneron, 2, Roche, 2, Sanofi, 2, Takeda, 2, UCB Pharma, 2, Imaging and Rheumatology BV, 4; P. Mease, AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, 5, Celgene, 2, Boehringer Ingelheim, 2, Genentech, 2, 5, 6, Janssen, 2, 5, 6, Gilead Sciences, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 6, GSK, 2.

To cite this abstract in AMA style:

McInnes I, Rahman P, Gottlieb A, Hsia E, Kollmeier A, Xu X, Sheng S, Jiang Y, Shawi M, Chakravarty S, van der Heijde D, Mease P. Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19-Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-guselkumab-a-monoclonal-antibody-specific-to-the-p19-subunit-of-interleukin-23-through-2-years-results-from-a-phase-3-randomized-double-blind-placebo-controlled-study-cond/. Accessed February 6, 2023.

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