Katalog Plus
Bibliothek der Frankfurt UAS
Bald neuer Katalog: sichern Sie sich schon vorab Ihre persönlichen Merklisten im Nutzerkonto: Anleitung.
Dieses Ergebnis aus MEDLINE kann Gästen nicht angezeigt werden.  Login für vollen Zugriff.

Adverse events with IL-17 and IL-23 inhibitors for psoriasis and psoriatic arthritis: a systematic review and meta-analysis of phase III studies.

Title: Adverse events with IL-17 and IL-23 inhibitors for psoriasis and psoriatic arthritis: a systematic review and meta-analysis of phase III studies.
Authors: Loft ND; Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.; Vaengebjerg S; Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.; Halling AS; Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.; Skov L; Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.; Egeberg A; Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark.
Source: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2020 Jun; Vol. 34 (6), pp. 1151-1160. Date of Electronic Publication: 2019 Dec 09.
Publication Type: Journal Article; Meta-Analysis; Systematic Review
Language: English
Journal Info: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE
Imprint Name(s): Publication: Oxford : Wiley-Blackwell; Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992-
MeSH Terms: Arthritis, Psoriatic*/drug therapy ; Psoriasis*/drug therapy; Antibodies, Monoclonal ; Humans ; Interleukin-17 ; Interleukin-23
Abstract: Biologics targeting interleukin (IL)-17 and IL-23 are generally well-tolerated and considered safe, though adverse events are seen more often compared with placebo. The objectives of this systematic review and meta-analysis were to assess the prevalence of adverse events in patients with psoriasis or psoriatic arthritis with any adverse events after 12, 16, 24 and 52 weeks of treatment with IL-17 or IL-23 inhibitors. Two independent authors searched the databases PubMed and EMBASE for studies reporting on adverse events in phase 3 trials of IL-17 and IL-23 inhibitors for patients with psoriasis and psoriatic arthritis. The study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data synthesis was performed using a random-effects model. In total, 44 publications (43 studies) were included in the analyses. The proportion of patients with any adverse events for all treatments pooled were 0.57 [95% confidence interval (CI): 0.55-0.59] after 12 weeks, 0.52 (95% CI: 0.49-0.55) after 16 weeks, 0.72 (95% CI: 0.66-0.78) after 24 weeks and 0.81 (95% CI: 0.76-0.86) after 52 weeks. Across therapies, the most prevalent AEs were infections, nasopharyngitis and headache. For ixekizumab one of the most prevalent AEs was injection site reactions, reported in 15.7% of the patients after 52 weeks. Overall, IL-17 and IL-23 inhibitors appear to be well-tolerated with good safety profiles. Our findings may aid the clinical decision making when choosing the most appropriate therapy for patients with moderate-to-severe psoriasis.; (© 2019 European Academy of Dermatology and Venereology.)
References: Di Cesare A, Di Meglio P, Nestle FO. The IL-23/Th17 axis in the immunopathogenesis of psoriasis. J Invest Dermatol 2009; 129: 1339-1350.; Krueger JG, Ferris LK, Menter A et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2015; 136: 116-124 e117.; Papp K, Thaçi D, Reich K et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol 2015; 173: 930-939.; Sofen H, Smith S, Matheson RT et al. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol 2014; 133: 1032-1040.; Papp K, Langley R, Sigurgeirsson B et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol 2013; 168: 412-421.; Leonardi C, Matheson R, Zachariae C et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med 2012; 366: 1190-1199.; Papp KA, Leonardi C, Menter A et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med 2012; 366: 1181-1189.; Cui L, Chen R, Subedi S et al. Efficacy and safety of biologics targeting IL-17 and IL-23 in the treatment of moderate-to-severe plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials. Int Immunopharmacol 2018; 62: 46-58.; Bilal J, Berlinberg A, Bhattacharjee S, Trost J, Riaz IB, Kurtzman DJ. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab and tildrakizumab for the treatment of moderate to severe plaque psoriasis. J Dermatol Treat 2018; 29: 569-578.; Saunte D, Mrowietz U, Puig L, Zachariae C. Candida infections in psoriasis and psoriatic arthritis patients treated with IL-17 inhibitors and their practical management. Br J Dermatol 2017; 177: 47-62.; Targan SR, Feagan B, Vermeire S et al. A randomized, double-blind, placebo-controlled phase 2 study of brodalumab in patients with moderate-to-severe Crohn's disease. Am J Gastroenterol 2016; 111: 1599-1607.; Hueber W, Sands BE, Lewitzky S et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut 2012; 61: 1693-1700.; Loft ND, Vaengebjerg S, Halling-Sønderby AS, Skov L, Egeberg A. Study protocol: Adverse events in patients receiving placebo in phase III trials of biologics for psoriasis: a systematic review and meta-analysis. URL https://www.gentoftehospital.dk/afdelinger-og-klinikker/Afdeling-for-Allergi-Hud%E2%80%90og-Koenssygdomme/forskning/Sider/Research-(English).aspx (last accessed 19 June 2019).; Papp K, Reich K, Paul C et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol 2016; 175: 273-286.; Lebwohl M, Strober B, Menter A et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med 2015; 373: 1318-1328.; Yamasaki K, Nakagawa H, Kubo Y, Ootaki K, Group JBS. Efficacy and safety of brodalumab in patients with generalized pustular psoriasis and psoriatic erythroderma: results from a 52-week, open-label study. Br J Dermatol 2017; 176: 741-751.; Gordon KB, Blauvelt A, Papp KA et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med 2016; 375: 345-356.; Griffiths CE, Reich K, Lebwohl M et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet 2015; 386: 541-551.; Reich K, Pinter A, Lacour J et al. Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study. Br J Dermatol 2017; 177: 1014-1023.; Paul C, Griffiths CEM, van de Kerkhof PCM et al. Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: results from IXORA-S, a phase 3 study. J Am Acad Dermatol 2019; 80: 70-79 e73.; Langley R, Papp K, Gooderham M et al. Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol 2018; 178: 1315-1323.; Ryan C, Menter A, Guenther L et al. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase III b study of patients with moderate-to-severe genital psoriasis. Br J Dermatol 2018; 179: 844-852.; Mease PJ, van der Heijde D, Ritchlin CT et al. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis 2017; 76: 79-87.; van der Heijde D, Gladman DD, Kishimoto M et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol 2018; 45: 367-377.; Nash P, Kirkham B, Okada M et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet 2017; 389: 2317-2327.; Saeki H, Nakagawa H, Ishii T et al. Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis. J Eur Acad Dermatol Venereol 2015; 29: 1148-1155.; Saeki H, Nakagawa H, Nakajo K et al. Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: results from a 52-week, open-label, phase 3 study (UNCOVER-J). J Dermatol 2017; 44: 355-362.; Duffin KC, Bagel J, Bukhalo M et al. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A). J Eur Acad Dermatol Venereol 2017; 31: 107-113.; Khattri S, Goldblum O, Solotkin K et al. Early onset of clinical improvement with ixekizumab in a randomized, open-label study of patients with moderate-to-severe plaque psoriasis. J Clin Aesthet Dermatol 2018; 11: 33.; Mease PJ, McInnes IB, Kirkham B et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015; 373: 1329-1339.; McInnes IB, Mease PJ, Kirkham B et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386: 1137-1146.; Nash P, Mease PJ, McInnes IB et al. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther 2018; 20: 47.; Kivitz A, Nash P, Tahir H et al., the FUTURE 4 Study Group. Arthritis: primary results through 52 weeks from a phase-3 randomized placebo-controlled study (FUTURE 4). J Clin Rheumatol 20th Pan-American League of Associations of Rheumatology Congress, PANLAR 2018 Argentima. 2018; 1: S1-S2.; Mease P, van der Heijde D, Landewé R et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis 2018; 77: 890-897.; Langley RG, Elewski BE, Lebwohl M et al. Secukinumab in plaque psoriasis-results of two phase 3 trials. N Engl J Med 2014; 371: 326-338.; Bagel J, Duffin KC, Moore A et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol 2017; 77: 667-674.; Thaçi D, Blauvelt A, Reich K et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol 2015; 73: 400-409.; Blauvelt A, Reich K, Tsai T-F et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: results from the CLEAR study. J Am Acad Dermatol 2017; 76: 60-69 e69.; Gottlieb A, Sullivan J, van Doorn M et al. Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial. J Am Acad Dermatol 2017; 76: 70-80.; Mrowietz U, Leonardi CL, Girolomoni G et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol 2015; 73: 27-36 e21.; Imafuku S, Honma M, Okubo Y et al. Efficacy and safety of secukinumab in patients with generalized pustular psoriasis: a 52-week analysis from phase III open-label multicenter Japanese study. J Dermatol 2016; 43: 1011-1017.; Paul C, Lacour JP, Tedremets L et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol 2015; 29: 1082-1090.; Lacour JP, Paul C, Jazayeri S et al. Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial. J Eur Acad Dermatol Venereol 2017; 31: 847-856.; Blauvelt A, Prinz J, Gottlieb A et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol 2015; 172: 484-493.; Gottlieb AB, Blauvelt A, Prinz JC et al. Secukinumab self-administration by prefilled syringe maintains reduction of plaque psoriasis severity over 52 weeks: results of the FEATURE trial. J Drugs Dermatol 2016; 15: 1226-1234.; Sticherling M, Mrowietz U, Augustin M et al. Secukinumab is superior to fumaric acid esters in treating patients with moderate-to-severe plaque psoriasis who are naive to systemic treatments: results from the randomized controlled PRIME trial. Br J Dermatol 2017; 177: 1024-1032.; Costanzo A, Bianchi L, Flori M et al. Secukinumab shows high efficacy irrespective of HLA-Cw6 status in patients with moderate-to-severe plaque-type psoriasis: SUPREME study. Br J Dermatol 2018; 179: 1072-1080.; Bagel J, Nia J, Hashim PW et al. Secukinumab is superior to ustekinumab in clearing skin in patients with moderate to severe plaque psoriasis (16-Week CLARITY Results). Dermatol Therapy 2018; 8: 571-579.; Blauvelt A, Papp KA, Griffiths CE 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: 405-417.; Reich K, Armstrong AW, Foley P 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: 418-431.; 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: 1053-1062.; Sano S, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, a human interleukin-23 monoclonal antibody in Japanese patients with generalized pustular psoriasis and erythrodermic psoriasis: efficacy and safety analyses of a 52-week, phase 3, multicenter, open-label study. J Dermatol 2018; 45: 529-539.; Ferris L, Ott E, Jiang G, Hong H, Baran W. Efficacy and safety of guselkumab administered with a novel self-injection device for the treatment of moderate-to-severe psoriasis: results from the phase III ORION self-dose study through week 16. Acta Dermato-Venereologica 5th World Psoriasis & Psoriatic Arthritis Conference. 2018; 98: 29.; Blauvelt A, Papp KA, Gooderham M et al. Risankizumab efficacy/safety in moderate-to-severe plaque psoriasis: 16-week results from IMMHANCE. Acta Dermato-Venereologica 5th World Psoriasis & Psoriatic Arthritis Conference Sweden. 2018; 98: 30.; Reich K, Gooderham M, Thaçi D, Crowley J, Ryan C, Krueger J. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. Paris: 27th EADV Congress 2018.; Gordon KB, Strober B, Lebwohl M et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet 2018; 392: 650-661.; Reich K, Papp KA, Blauvelt A et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet 2017; 390: 276-288.; Conti HR, Gaffen SL. IL-17-Mediated immunity to the opportunistic fungal pathogen Candida albicans. J Immunol 2015; 195: 780-788.; Egeberg A. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med 2016; 375: 2101.; Langley RG, Kimball A, Nak H et al. Long-term safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis: an integrated analysis from 11 clinical trials. J Eur Acad Dermatol Venereol 2019; 33: 333-339.; Okubo Y, Ohtsuki M, Morita A et al. Long-term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3-year results of a double-blind extension study. J Dermatol 2019; 46: 186-192.; Mease PJ, Kavanaugh A, Reimold A et al. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open 2018; 4: e000723.; Kavanaugh A, Mease PJ, Reimold AM et al. Secukinumab for long-term treatment of psoriatic arthritis: a two-year followup from a phase III, randomized, double-blind placebo-controlled study. Arthritis Care Res (Hoboken) 2017; 69: 347-355.; McInnes IB, Mease PJ, Ritchlin CT et al. Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study. Rheumatology 2017; 56: 1993-2003.
Substance Nomenclature: 0 (Antibodies, Monoclonal); 0 (Interleukin-17); 0 (Interleukin-23)
Entry Date(s): Date Created: 20191114 Date Completed: 20210514 Latest Revision: 20250516
Update Code: 20260130
DOI: 10.1111/jdv.16073
PMID: 31721310
Database: MEDLINE

Journal Article; Meta-Analysis; Systematic Review