Comparative effectiveness of tildrakizumab 200 mg versus tildrakizumab 100 mg in psoriatic patients with high disease burden or above 90 kg of body weight: a 16-week multicenter retrospective study – IL PSO (Italian landscape psoriasis)

Abstract

Purpose

Tildrakizumab is a selective inhibitor of IL-23 approved for the treatment of moderate-to-severe plaque psoriasis in two dosages. We conducted a 16-week multicenter retrospective study to compare the effectiveness and safety of tildrakizumab 200 mg versus tildrakizumab 100 mg in patients with a high disease burden or high body weight.

Materials and methods

Our retrospective study included 134 patients treated with tildrakizumab 200 mg and 364 patients treated with tildrakizumab 100 mg from 28 Italian Dermatology Units affected by moderate-to-severe plaque psoriasis. The patients had a body weight above 90 kg or a high disease burden (Psoriasis Area and Severity Index [PASI] ≥ 16 or the involvement of difficult-to-treat areas). We evaluated the effectiveness of tildrakizumab at the week-16 visit in terms of PASI90, PASI100 and absolute PASI ≤ 2.

Results

After 16 weeks of treatment with tildrakizumab 200 mg, PASI90 was reached by 57.5% of patients and PASI100 by 39.6% of patients. At the same time point, 34.3% and 24.2% of patients treated with tildrakizumab 100 mg achieved PASI90 and PASI100, respectively.

Conclusions

Our data suggest that tildrakizumab 200 mg has better effectiveness than tildrakizumab 100 mg in patients with a body weight ≥ 90 kg and a high disease burden.

Keywords:

• Biologics
• psoriasis
• psoriasis treatment
• tildrakizumab

Acknowledgments

This work was partially supported by ‘Ricerca Corrente’ funding from Italian Ministry of Health to IRCCS Humanitas Research Hospital.

Compliance with ethics guidelines

Institutional review board approval was exempted as the study protocol did not deviate from standard clinical practice. All patients received upadacitinib as in good clinical practice, in accordance with European guidelines. All included patients had provided written consent for retrospective study of data collected during routine clinical practice (demographics, clinical scores). The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. Data collection and handling complied with applicable laws, regulations, and guidance regarding patient protection, including patient privacy.

Disclosure statement

L. Gargiulo has been a consultant and/or speaker for Almirall, UCB and Pfizer. L. Ibba has been a consultant for Almirall. P. Malagoli has been a speaker for AbbVie, Lilly, Novartis, Janssen-Cilag, Celgene, Leopharma, and Almirall. A. Balato has received honoraria for participation in advisory boards, meetings, or as speaker for AbbVie, Celgene, Janssen-Cilag, Eli Lilly, Novartis Pharma, Pfizer, Sanofi-Genzyme, and UCB Pharma. F. Bardazzi has been a consultant adviser and clinical study investigator for Eli Lilly, Abbvie, Novartis, Leo Pharma, Sandoz, Bristol Myers, Abiogen-Pharma, Celgene and Janssen. M. Burlando has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly, UCB Pharma. C. G. Carrera has served as a board participant or speaker for Abbvie, Lilly, Janssen, Novartis, Celgene, Almirall, and Leopharma. P. Dapavo has been a speaker for Novartis, Abbvie, Sanofi, UCB, Janssen, Lilly, and LeoPharma. F. M. Gaiani acted as a speaker or consultant for Novartis, Abbvie, Eli Lilly, Celgene, LeoPharma, and Almirall. P. Gisondi has been a consultant and/or speaker for Abbvie, Almirall, Amgen, Janssen, Leo-Pharma, Eli-Lilly, Novartis, Pierre Febre, Sandoz, Sanofi and UCB. C. Guarneri has been a scientific consultant/speaker/clinical study investigator for Abbvie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sanofi, Almirall, LEO Pharma. C. Lasagni declares a conflict of interest with Abbvie, Novartis, Lilly and Almirall. F. Loconsole served on advisory boards and/or received honoraria for lectures from Abbvie, Janssen-Cilag, Novartis, Lilly, Sanofi. A. V. Marzano reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi and UCB. M. Megna acted as a speaker or consultant for Abbvie, Eli Lilly, Janssen, Leo-Pharma, and Novartis. M. L. Musumeci has previously served as advisory board member and consultant, and has received speaker’s honoraria and fees for her participation to clinical trials for Abbvie, Almirall, Biogen, Eli-Lilly, Janssen Cilag, Leo Pharma, and Novartis. D. Orsini has been a speaker and/or consultant for Abbvie, LeoPharma, uCB, Bristol-Meyer-Squibb and Boehringer-Ingelheim. S. Ribero has served as advisory board member and/or consultant and has received fees and speaker’s honoraria or has participated for clinical studies for AbbVie, Almirall, Leo Pharma, Eli Lilly, Novartis, Pfizer and Sanofi Genzyme. D. Strippoli has been a consultant and/or speaker for Abbvie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer. E. Trovato is involved in an intermittent project focused on consulting and/or advisory relationships or/and travel-congress support with Eli-Lilly, Novartis, Janssen-Cilag, Abbvie and Almirall. M. Valenti has been a consultant and/or speaker for Sanofi, Leo Pharma, Eli Lilly, Novartis, Janssen, AbbVie and Boehringer Ingelheim. M. Venturini served as a speaker or advisory board member for Abbvie, Almirall, Amgen, Eli-Lilly, Galderma, Leo Pharma, Novartis, Pierre Fabre, and UCB Pharma. L. Zichichi has received grants for scientific contributions from AbbVie, Almirall, Amgen, Lilly and Novartis. A. Costanzo has served as an advisory board member, consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, LEO Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. A. Narcisi has served on advisory boards, received honoraria for lectures and research grants from Almirall, Abbvie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Genzyme, Amgen and Boehringer Ingelheim. R. Cascio Ingurgio, F. Amoruso, P. Brianti, G. Brunasso, A. E. Cagni, M. Caproni, A. Carugno, F. Caudullo, A. Cuccia, E. V. Di Brizzi, V. Dini, G. Licata, S. R. Mercuri, V. Ruffo Di Calabria, F. Satolli, M. Travaglini have nothing to declare.

Data availability statement

All the patients’ data and information supporting the findings of the study are available from the corresponding author upon reasonable request.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.