Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Armstrong A, Bohannan B, Mburu S, Alarcon I, Kasparek T, Toumi J, et al. Impact of psoriatic disease on quality of life: interim results of a global survey. Dermatol Ther (Heidelb). 2022;12:1055–64. https://doi.org/10.1007/s13555-022-00695-0.

Article  PubMed  PubMed Central  Google Scholar 

Yan D, Blauvelt A, Dey AK, Golpanian RS, Hwang ST, Mehta NN, et al. New frontiers in psoriatic disease research, part II: comorbidities and targeted therapies. J Invest Dermatol. 2021;141:2328–37. https://doi.org/10.1016/j.jid.2021.02.743.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Novelli L, Lubrano E, Venerito V, Perrotta FM, Marando F, Curradi G, et al. Extra-articular manifestations and comorbidities in psoriatic disease: a journey into the immunologic crosstalk. Front Med. 2021;8: 737079. https://doi.org/10.3389/fmed.2021.737079.

Article  Google Scholar 

Lebwohl M, Langley RG, Paul C, Puíg L, Reich K, van de Kerkhof P, et al. Evolution of patient perceptions of psoriatic disease: results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey. Dermatol Ther (Heidelb). 2022;12:61–78. https://doi.org/10.1007/s13555-021-00635-4.

Article  PubMed  Google Scholar 

Samartín-Ucha M, Pego-Reigosa JM, Álvarez-Payero M, Martin-Vila A, Pineiro-Corrales G, Rodriguez-Rodriguez M, et al. Medication persistence on biological therapies prescribed for the treatment of chronic inflammatory arthropathies: a real-world data study. Eur J Hosp Pharm. 2021;28(Suppl 2):e47-50. https://doi.org/10.1136/ejhpharm-2019-002133.

Article  PubMed  Google Scholar 

Ceccarelli M, Venanzi Rullo E, Berretta M, Cacopardo B, Pellicanò GF, Nunnari G, et al. New generation biologics for the treatment of psoriasis and psoriatic arthritis. State of the art and considerations about the risk of infection. Dermatol Ther. 2021;34: e14660. https://doi.org/10.1111/dth.14660.

Article  PubMed  Google Scholar 

Sbidian E, Chaimani A, Garcia-Doval I, Doney L, Dressler C, Hua C, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2021. https://doi.org/10.1002/14651858.CD011535.pub4.

Article  PubMed  PubMed Central  Google Scholar 

Yang K, Oak ASW, Elewski BE. Use of IL-23 inhibitors for the treatment of plaque psoriasis and psoriatic arthritis: a comprehensive review. Am J Clin Dermatol. 2021;22:173–92. https://doi.org/10.1007/s40257-020-00578-0.

Article  PubMed  Google Scholar 

Sumpton D, Kelly A, Tunnicliffe DJ, Craig JC, Hassett G, Chessman D, et al. Patients’ perspectives and experience of psoriasis and psoriatic arthritis: a systematic review and thematic synthesis of qualitative studies. Arthritis Care Res (Hoboken). 2020;72:711–22. https://doi.org/10.1002/acr.23896.

Article  PubMed  Google Scholar 

Sain N, Willems D, Charokopou M, Hiligsmann M. The importance of understanding patient and physician preferences for psoriasis treatment characteristics: a systematic review of discrete-choice experiments. Curr Med Res Opin. 2020;36:1257–75. https://doi.org/10.1080/03007995.2020.1776233.

Article  PubMed  Google Scholar 

Strober B, Karki C, Mason M, Guo N, Holmgren SH, Greenberg JD, et al. Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: results from the Corrona Psoriasis Registry. J Am Acad Dermatol. 2018;78:323–32. https://doi.org/10.1016/j.jaad.2017.10.012.

Article  PubMed  Google Scholar 

Coates LC, Soriano ER, Corp N, Bertheussen H, Callis Duffin K, Campanholo CB, GRAPPA Treatment Recommendations domain subcommittees, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18:465–79. https://doi.org/10.1038/s41584-022-00798-0.

Article  PubMed  PubMed Central  Google Scholar 

Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, et al. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021;185:1146–59. https://doi.org/10.1111/bjd.20568.

Article  CAS  PubMed  Google Scholar 

Blauvelt A, Tsai T-F, Langley RG, Miller M, Shen Y-K, You Y, et al. Consistent safety profile with up to 5 years of continuous treatment with guselkumab: pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis. J Am Acad Dermatol. 2022;86:827–34. https://doi.org/10.1016/j.jaad.2021.11.004.

Article  CAS  PubMed  Google Scholar 

Lebwohl MG, Merola JF, Rowland K, Miller M, Yang Y-W, Yu J, et al. Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses across seven clinical trials with greater than 8600 patient-years of exposure. Br J Dermatol. 2023;189:42–52. https://doi.org/10.1093/bjd/ljad115.

Article  PubMed  Google Scholar 

McInnes IB, Rahman P, Gottlieb AB, Hsia EC, Kollmeier AP, Xu XL, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naive patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74:475–85. https://doi.org/10.1002/art.42010.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rahman P, Boehncke W-H, Mease PJ, Gottlieb AB, McInnes IB, Shawi M, et al. Safety of guselkumab with and without prior tumor necrosis factor inhibitor treatment: pooled results across 4 studies in patients with psoriatic arthritis. J Rheumatol. 2023;50:769–80. https://doi.org/10.3899/jrheum.220928.

Article  CAS  PubMed  Google Scholar 

Gordon KB, Callis Duffin K, Bissonnette R, Prinz JC, Wasfi Y, Li S, et al. A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis. N Engl J Med. 2015;373:136–44. https://doi.org/10.1056/NEJMoa1501646.

Article  CAS  PubMed  Google Scholar 

Blauvelt A, Papp KA, Griffiths CEM, Randazzo B, Wasfi Y, Shen Y-K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76:405–17. https://doi.org/10.1016/j.jaad.2016.11.041.

Article  CAS  PubMed  Google Scholar 

Reich K, Armstrong AW, Foley P, Song M, Wasfi Y, Randazzo B, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76:418–31. https://doi.org/10.1016/j.jaad.2016.11.042.

Article  CAS  PubMed  Google Scholar 

Langley RG, Tsai T-F, Flavin S, Song M, Randazzo B, Wasfi Y, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol. 2018;178:114–23. https://doi.org/10.1111/bjd.15750.

Article  CAS  PubMed  Google Scholar 

Ferris LK, Ott E, Jiang J, Hong HC-H, Li S, Han C, et al. Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatolog Treat. 2020;31:152–9. https://doi.org/10.1080/09546634.2019.1587145.

Article  CAS  PubMed  Google Scholar 

Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394:831–9. https://doi.org/10.1016/S0140-6736(19)31773-8.

Article  CAS  PubMed  Google Scholar 

Ohtsuki M, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018;45:1053–62. https://doi.org/10.1111/1346-8138.14504.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Deodhar A, Gottlieb AB, Boehncke W-H, Dong B, Wang Y, Zhuang Y, CNTO1959PSA2001 Study Group, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2018;391:2213–24. https://doi.org/10.1016/S0140-6736(18)30952-8.

Article  CAS  PubMed  Google Scholar 

Deodhar A, Helliwell PS, Boehncke W-H, Kollmeier AP, Hsia EC, Subramanian RA, DISCOVER-1 Study Group, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395:1115–25. https://doi.org/10.1016/S0140-6736(20)30265-8.

Article  CAS  PubMed  Google Scholar 

Mease PJ, Rahman P, Gottlieb AB, Kollmeier AP, Hsia EC, Xu XL, DISCOVER-2 Study Group, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395:1126–36. https://doi.org/10.1016/S0140-6736(20)30263-4.

Article  CAS  PubMed  Google Scholar 

Coates LC, Gossec L, Theander E, Bergmans P, Neuhold M, Karyekar CS, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022;81:359–69. https://doi.org/10.1136/annrheumdis-2021-220991.

Article  CAS  PubMed  Google Scholar 

Fredriksson T, Pettersson U. Severe psoriasis–oral therapy with a new retinoid. Dermatologica. 1978;157:238–44. https://doi.org/10.1159/000250839.

Article  CAS  PubMed  Google Scholar 

Langley RGB, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator’s Global Assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015;26:23–31. https://doi.org/10.3109/09546634.2013.865009.

Article  CAS  PubMed  Google Scholar 

Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H, CA

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