ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2047

Safety in Patients with Latent Tuberculosis Who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease

Luis Puig1, Tsen-Fang Tsai2, Enrique R. Soriano3, Tina Bhutani4, Megan Miller5, Alexa P. Kollmeier5, Shu Li5, Yin You5, Melissa Petrick5, Hewei Li6, Hetal Patel7, Frederic Lavie8, Melinda Gooderham9, Angela Londoño10, Mark Lebwohl11 and Peter Nash12, 1Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, 2National Taiwan University Hospital, Taipei, Taiwan (Republic of China), 3Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, 4University of California San Francisco Medical Center, San Francisco, CA, 5Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, 6Janssen Pharmaceutical, Hopewell Township, NJ, 7Pharmaceutical Companies of Johnson & Johnson, Naperville, IL, 8Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 9SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada, 10CES University, Medellín, Colombia, 11Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 12School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia

Meeting: ACR Convergence 2024

Keywords: , ,

Session Information

Date: Monday, November 18, 2024

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: Certain psoriatic disease treatments, including TNF-α inhibitors (TNFi), increase risk of latent tuberculosis infection (LTBI) activation.1,2 Current treatment guidelines recommend TB screening before initiating systemic therapy.3,4 Here, we reported safety outcomes in LTBI+ patients (pts) with moderate-to-severe psoriasis (PsO) or active PsA who received guselkumab (GUS) for up to 5 years (yrs).

Methods: Safety data were pooled from 11 phase 2/3 studies (7 PsO, 4 PsA). GUS was administered as 100 mg subcutaneous injections – PsO studies: at Week (W)0, W4, then every 8 weeks (q8w); PsA studies: at W0, W4, then q4w/q8w. Pts randomized to placebo (PBO) crossed over to GUS at W16 in PsO studies and at W24 in PsA studies. Pts were screened for TB at baseline. Pts with active TB were excluded. Pts with LTBI were eligible if appropriate LTBI treatment was to be initiated prior to/with the first study drug administration, or if appropriate treatment had been completed within 5 yrs. Safety was reported for PBO-controlled period, yr-by-yr, and through the end of follow-up (PsO: up to 5 yrs; PsA: up to 2 yrs).

Results: Among all randomized pts, 10.0% (70/697) from Asia-Pacific, 7.3% (51/698) from Western Europe, 7.3% (179/2453) from Eastern Europe, and 5.3% (74/1407) from North America had LTBI. LTBI treatment initiation occurred prior to (88.2% [330/374]), with (6.1% [ 23/374]), or after (5.6% [21/374]) the first dose of study drug (median, -8.0 days; interquartile range [IQR], -20.0 to -2.0). LTBI treatments included isoniazid (82.1%), rifampicin (11.8%), and other medications (17.4%); 89.8% received monotherapy. No new-onset TB/LTBI activation was observed in any GUS-treated pt. During PBO-controlled period, rates of adverse events (AEs) and serious AEs were similar for GUS- and PBO-treated pts in the LTBI+ and LTBI- groups (Table 1). Through the end of follow-up, GUS-treated LTBI+ and LTBI- pts had similar cumulative rates of AEs and serious AEs. Through Yr 1, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were more common in the LTBI+ vs LTBI- group; ≤2% of LTBI+ pts had CTCAE Grade 3 elevations vs 0.5% of LTBI- pts (no LTBI+ pts had Grade 4 elevations) (Table 2). From Yr 1-5 (after ~98% of LTBI+ pts completed prophylaxis [median (IQR) treatment duration=185 (124-274) days]), proportions of LTBI+ pts with elevated ALT/AST were generally similar to the LTBI- group.

Conclusion: No new-onset TB/LTBI activation was observed in up to 5 yrs of GUS treatment. GUS safety was generally similar in LTBI+ and LTBI- pts. Consistent with the known safety of LTBI medications,5 ALT/AST elevations were more common in LTBI+ vs LTBI- pts through Yr 1; ≤2% of LTBI+ pts had Grade 3 vs 0 had Grade 4 elevations. Rates of ALT/AST elevation were generally similar in LTBI+ and LTBI- pts post-LTBI treatment. The absence of observed TB risk in GUS-treated pts suggests GUS may be a better treatment option than TNFi in high-risk pts, including those in TB-endemic regions.

1Kaushik SB. J Am Acad Dermatol. 2019; 80:43-53.

2Gialouri CG. Mediterr J Rheumatol. 2022; 33:150-61.

3Menter AM. J Am Acad Dermatol. 2019; 80:1029-72.

4Coates LC. Nat Rev Rheumatol. 2022; 18:465-79.

5Tostmann A. J Gastroenterol Hepatol. 2008; 23:192-202.

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Disclosures: L. Puig: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, 6, Baxalta, 2, 5, 6, Biogen, 2, 5, 6, Boehringer Ingelheim, 2, 5, 6, Bristol Myers Squibb, 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 5, 6, Gebro, 2, 5, 6, Janssen, 2, 5, 6, JS BIOCAD, 2, 5, 6, LEO Pharma, 2, 5, 6, Merck-Serono, 2, 5, 6, MSD, 2, 5, 6, Mylan, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Regeneron, 2, 5, 6, Roche, 2, 5, 6, Samsung-Bioepis, 2, 5, 6, Sandoz, 2, 5, 6, Sanofi-Genzyme, 2, 5, 6, UCB, 2, 5, 6; T. Tsai: AbbVie, 2, Boehringer-Ingelheim, 2, Bristol-Myers Squibb(BMS), 2, Celgene, 2, Eli Lilly, 2, Galderma, 2, GlaxoSmithKlein(GSK), 2, Janssen-Cilag, 2, LEO, 2, Merck Sharp & Dohme, 2, Novartis, 2, Pfizer, 2, Sanofi, 2, UCB, 2; E. Soriano: AbbVie, 2, 5, 6, Amgen, 6, Bristol Myers Squibb, 6, Eli Lilly, 6, Janssen, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 5, 6, Roche, 2, 5, 6, UCB, 5, 6; T. Bhutani: AbbVie, 1, 12, Principal investigator:, Arcutis, 1, Boehringer-Ingelheim, 1, Bristol-Myers Squibb(BMS), 1, Castle, 12, Principal investigator, CorEvitas, 1, Dermavant, 12, Principal investigator, Eli Lilly, 1, Galderma, 12, Principal investigator, Janssen, 1, Leo Pharma, 1, Mindera, 12, Principal investigator, Novartis, 5, Pfizer, 1, 12, Principal investigator, Regeneron, 5, Sun, 1, UCB, 1; M. Miller: Janssen, 3, Johnson & Johnson, 11; A. Kollmeier: Janssen, 3, Johnson & Johnson, 11; S. Li: Janssen, 3, Johnson & Johnson, 11; Y. You: Janssen, 3, Johnson & Johnson, 11; M. Petrick: Janssen, 3, Johnson & Johnson, 11; H. Li: Janssen, 3, Johnson & Johnson, 11; H. Patel: Johnson & Johnson, 3, 11; F. Lavie: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, 3, Johnson & Johnson, 11; M. Gooderham: AbbVie, 1, 2, 6, Akros, 1, 2, 6, Amgen, 1, 2, 6, AnaptysBio, 1, 2, 6, Apogee, 1, 2, 6, Arcutis, 1, 2, 6, Aristea, 1, 2, 6, Bausch Health, 1, 2, 6, Boehringer Ingelheim, 1, 2, 6, Bristol Myers Squibb, 1, 2, 6, Celgene, 1, 2, 6, Dermavant, 1, 2, 6, Dermira, 1, 2, 6, Eli Lilly, 1, 2, 6, Galderma, 1, 2, 6, GSK, 1, 2, 6, Horizon, 1, 2, 6, Incyte, 1, 2, 6, Inmagene, 1, 2, 6, Janssen, 1, 2, 6, Kyowa Kirin, 1, 2, 6, LEO Pharma, 1, 2, 6, MedImmune, 1, 2, 6, Meiji, 1, 2, 6, Merck, 1, 2, 6, MoonLake, 1, 2, 6, Nimbus, 1, 2, 6, Novartis, 1, 2, 6, Pfizer, 1, 2, 6, Regeneron, 1, 2, 6, Roche, 1, 2, 6, Sanofi Genzyme, 1, 2, 6, Sun Pharma, 1, 2, 6, Takeda, 1, 2, 6, Tarsus, 1, 2, 6, UCB, 1, 2, 6, Union, 1, 2, 6, Ventyx, 1, 2, 6; A. Londoño: AbbVie, 2, Boehringer-Ingelheim, 2, Bristol-Myers Squibb(BMS), 2, Eli Lilly, 2, Galderma, 2, Janssen-Cilag, 2, LEO, 2, Novartis, 2, Pfizer, 2, Sanofi, 2; M. Lebwohl: AbbVie, 5, Almirall, 2, AltruBio Inc., 2, Amgen, 5, AnaptysBio, 2, Arcutis, 2, 5, AstraZeneca, 2, Avotres, 2, 5, Boehringer Ingelheim, 2, 5, Brickell Biotech, 2, Bristol Myers Squibb, 2, Cara Therapeutics, 5, Castle Biosciences, 2, Celltrion, 2, CorEvitas, 2, Dermavant Sciences, 2, 5, Eli Lilly, 5, EPI, 2, Evommune Inc., 2, Facilitation of International Dermatology Education, 2, Forte Biosciences, 2, Foundation for Research and Education in Dermatology, 2, Galderma, 2, Genentech, 2, Incyte, 2, 5, Inozyme, 5, Janssen, 5, LEO Pharma, 2, LLC, 5, Meiji Seika Pharma, 2, Mindera, 2, Mount Sinai, 3, Ortho Dermatologics, 5, Pfizer, 2, Sanofi-Regeneron, 5, Seanergy, 2, Strata, 2, Trevi, 2, UCB Pharma, 5, Verrica, 2; P. Nash: AbbVie, 5, 6, BMS, 5, 6, Boehringer Ingelheim, 5, 6, Eli Lilly, 5, 6, Gilead/Galapagos, 5, 6, GSK, 5, 6, Janssen, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Samsung, 5, 6, Sanofi, 5, 6, UCB Pharma, 5, 6.

To cite this abstract in AMA style:

Puig L, Tsai T, Soriano E, Bhutani T, Miller M, Kollmeier A, Li S, You Y, Petrick M, Li H, Patel H, Lavie F, Gooderham M, Londoño A, Lebwohl M, Nash P. Safety in Patients with Latent Tuberculosis Who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/safety-in-patients-with-latent-tuberculosis-who-received-concomitant-anti-tuberculosis-medications-analysis-of-11-studies-of-guselkumab-in-psoriatic-disease/. Accessed .

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