Novel Therapeutic Approaches and Treatment Targets for Psoriatic Arthritis

Author(s): Devis Benfaremo, Valentino Paci, Michele Maria Luchetti*, Armando Gabrielli

Journal Name: Current Pharmaceutical Biotechnology

Volume 22 , Issue 1 , 2021


Become EABM
Become Reviewer
Call for Editor

Graphical Abstract:


Abstract:

Background: Psoriatic Arthritis (PsA) is the most common extracutaneous manifestation of psoriasis. This chronic inflammatory arthritis is burdened with significant morbidity, leading to irreversible joint damage and disability. In recent years, a deeper understating of its pathogenesis has led to the development of several new drugs targeting different pathways.

Objectives: This review aims to highlight the clinical efficacy and safety of the novel agents that have become recently available for the treatment of PsA, as well as new promising therapeutic targets that are being evaluated in clinical trials.

Methods: For the purpose of this narrative review, we searched in the MEDLINE and ClinicalTrials. gov databases.

Results: After the introduction of the first biological drugs targeting Tumor Necrosis Factor (TNF), several other drugs with different targets have been developed, including anti-Interleukin (IL) 12/23p40, anti-IL17, and, more recently, anti-IL23p19 agents.

Discussion: Data supporting the efficacy of different agents in the major domains of PsA, as well as their safety issues, are summarized here. Finally, the current pipeline, including several novel nonbiological small molecules, such as Janus kinase (JAK) inhibitors, that are currently being evaluated in clinical trials are also presented.

Conclusion: The availability of newer therapeutic agents has substantially changed the treatment strategy for PsA. In the future, a personalized treatment approach will probably achieve better control of disease manifestations.

Keywords: Anti-IL17 agents, Anti-IL12/23p40 agent, psoriatic arthritis, Anti-IL23p19 agent, PDE-4 inhibitor, JAK inhibitors.

[1]
Ritchlin, C.T.; Colbert, R.A.; Gladman, D.D. Psoriatic Arthritis. N. Engl. J. Med., 2017, 376(10), 957-970.
[http://dx.doi.org/10.1056/NEJMra1505557] [PMID: 28273019]
[2]
Luchetti, M.M.; Benfaremo, D.; Gabrielli, A. Biologics in inflammatory and immunomediated arthritis. Curr. Pharm. Biotechnol., 2017, 18(12), 989-1007.
[http://dx.doi.org/10.2174/1389201019666171226151852] [PMID: 29278210]
[3]
Campanati, A.; Benfaremo, D.; Luchetti, M.M.; Ganzetti, G.; Gabrielli, A.; Offidani, A. Certolizumab pegol for the treatment of psoriasis. Expert Opin. Biol. Ther., 2017, 17(3), 387-394.
[http://dx.doi.org/10.1080/14712598.2017.1283401] [PMID: 28165828]
[4]
Gossec, L.; Smolen, J.S.; Ramiro, S.; de Wit, M.; Cutolo, M.; Dougados, M.; Emery, P.; Landewé, R.; Oliver, S.; Aletaha, D.; Betteridge, N.; Braun, J.; Burmester, G.; Cañete, J.D.; Damjanov, N.; FitzGerald, O.; Haglund, E.; Helliwell, P.; Kvien, T.K.; Lories, R.; Luger, T.; Maccarone, M.; Marzo-Ortega, H.; McGonagle, D.; McInnes, I.B.; Olivieri, I.; Pavelka, K.; Schett, G.; Sieper, J.; van den Bosch, F.; Veale, D.J.; Wollenhaupt, J.; Zink, A.; van der Heijde, D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 Update. Ann. Rheum. Dis., 2016, 75(3), 499-510.
[5]
Coates, L.C.; Kavanaugh, A.; Mease, P.J.; Soriano, E.R.; Laura Acosta-Felquer, M.; Armstrong, A.W.; Bautista-Molano, W.; Boehncke, W-H.; Campbell, W.; Cauli, A.; Espinoza, L.R.; FitzGerald, O.; Gladman, D.D.; Gottlieb, A.; Helliwell, P.S.; Husni, M.E.; Love, T.J.; Lubrano, E.; McHugh, N.; Nash, P.; Ogdie, A.; Orbai, A-M.; Parkinson, A.; O’Sullivan, D.; Rosen, C.F.; Schwartzman, S.; Siegel, E.L.; Toloza, S.; Tuong, W.; Ritchlin, C.T. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol., 2016, 68(5), 1060-1071.
[http://dx.doi.org/10.1002/art.39573] [PMID: 26749174]
[6]
Salaffi, F.; Di Carlo, M.; Luchetti, M.M.; Di Donato, E.; Campanati, A.; Benfaremo, D.; Nicolini, M.; Carotti, M.; Giacchetti, A.; Ganzetti, G.; Bugatti, L.; Gabrielli, A.; Offidani, A.M. A validation study of the Simple Psoriatic Arthritis Screening (SiPAS) questionnaire to screen psoriasis patients for psoriatic arthritis. Clin. Exp. Rheumatol., 2018, 36(1), 127-135.
[PMID: 29148421]
[7]
Luchetti, M.M.; Ciccia, F.; Avellini, C.; Benfaremo, D.; Guggino, G.; Farinelli, A.; Ciferri, M.; Rossini, M.; Svegliati, S.; Spadoni, T.; Bolognini, L.; Fava, G.; Mosca, P.; Gesuita, R.; Skrami, E.; Triolo, G.; Gabrielli, A. Sclerostin and antisclerostin antibody serum levels predict the presence of axial spondyloarthritis in patients with inflammatory bowel disease. J. Rheumatol., 2018, 45(5), 630-637.
[http://dx.doi.org/10.3899/jrheum.170833] [PMID: 29419466]
[8]
Luchetti, M.M.; Benfaremo, D.; Campanati, A.; Molinelli, E.; Ciferri, M.; Cataldi, S.; Capeci, W.; Di Carlo, M.; Offidani, A.M.; Salaffi, F.; Gabrielli, A. Clinical outcomes and feasibility of the multidisciplinary management of patients with psoriatic arthritis: Two-year clinical experience of a dermo-rheumatologic clinic. Clin. Rheumatol., 2018, 37(10), 2741-2749.
[http://dx.doi.org/10.1007/s10067-018-4238-4] [PMID: 30056525]
[9]
McInnes, I.B.; Kavanaugh, A.; Gottlieb, A.B.; Puig, L.; Rahman, P.; Ritchlin, C.; Brodmerkel, C.; Li, S.; Wang, Y.; Mendelsohn, A.M.; Doyle, M.K. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet, 2013, 382(9894), 780-789.
[http://dx.doi.org/10.1016/S0140-6736(13)60594-2] [PMID: 23769296]
[10]
Ritchlin, C.; Rahman, P.; Kavanaugh, A.; McInnes, I.B.; Puig, L.; Li, S.; Wang, Y.; Shen, Y-K.; Doyle, M.K.; Mendelsohn, A.M.; Gottlieb, A.B. Efficacy and safety of the anti-IL-12/23 P40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3 M. Ann. Rheum. Dis., 2014, 73(6), 990-999.
[11]
Araujo, E.G.; Englbrecht, M.; Hoepken, S.; Finzel, S.; Kampylafka, E.; Kleyer, A.; Bayat, S.; Schoenau, V.; Hueber, A.; Rech, J.; Schett, G. Effects of ustekinumab versus tumor necrosis factor inhibition on enthesitis: Results from the Enthesial Clearance in Psoriatic Arthritis (ECLIPSA) study. Semin. Arthritis Rheum., 2019, 48(4), 632-637.
[http://dx.doi.org/10.1016/j.semarthrit.2018.05.011] [PMID: 30037432]
[12]
Deodhar, A.; Gensler, L.S.; Sieper, J.; Clark, M.; Calderon, C.; Wang, Y.; Zhou, Y.; Leu, J.H.; Campbell, K.; Sweet, K.; Harrison, D.D.; Hsia, E.C.; van der Heijde, D. Three multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of ustekinumab in axial spondyloarthritis. Arthritis Rheumatol., 2019, 71(2), 258-270.
[http://dx.doi.org/10.1002/art.40728] [PMID: 30225992]
[13]
Kavanaugh, A.; Ritchlin, C.; Rahman, P.; Puig, L.; Gottlieb, A.B.; Li, S.; Wang, Y.; Noonan, L.; Brodmerkel, C.; Song, M.; Mendelsohn, A.M.; McInnes, I.B. Ustekinumab, an anti-IL-12/23 P40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: Results of an integrated analysis of radiographic data from the phase 3 multicentre, randomised, double-blind, placebo-C. Ann. Rheum. Dis., 2014, 73(6), 1000-1006.
[14]
Ghosh, S.; Gensler, L.S.; Yang, Z.; Gasink, C.; Chakravarty, S.D.; Farahi, K.; Ramachandran, P.; Ott, E.; Strober, B.E. Ustekinumab safety in psoriasis, psoriatic arthritis, and crohn’s disease: An integrated analysis of phase II/III clinical development programs. Drug Saf., 2019, 42(6), 751-768.
[http://dx.doi.org/10.1007/s40264-019-00797-3] [PMID: 30739254]
[15]
Almirall, M.; Rodriguez, J.; Mateo, L.; Carrascosa, J.M.; Notario, J.; Gallardo, F. Treatment with ustekinumab in a Spanish cohort of patients with psoriasis and psoriatic arthritis in daily clinical practice. Clin. Rheumatol., 2017, 36(2), 439-443.
[http://dx.doi.org/10.1007/s10067-016-3464-x] [PMID: 27817126]
[16]
Chimenti, M.S.; Ortolan, A.; Lorenzin, M.; Triggianese, P.; Talamonti, M.; Costa, L.; Caso, F.; Favero, M.; Teoli, M.; Galluzzo, M.; Scarpa, R.; Punzi, L.; Perricone, R.; Ramonda, R. Effectiveness and safety of ustekinumab in naïve or TNF-inhibitors failure psoriatic arthritis patients: A 24-month prospective multicentric study. Clin. Rheumatol., 2018, 37(2), 397-405.
[http://dx.doi.org/10.1007/s10067-017-3953-6] [PMID: 29302829]
[17]
Iannone, F.; Santo, L.; Bucci, R.; Semeraro, A.; Carlino, G.; Paoletti, F.; Quarta, L.; Leucci, P.; Zuccaro, C.; Marsico, A.; Scioscia, C.; D’Onofrio, F.; Mazzotta, D.; Muratore, M.; Cantatore, F.P.; Lapadula, G. Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the Biologic Apulian Registry (BIOPURE). Clin. Rheumatol., 2018, 37(3), 667-675.
[http://dx.doi.org/10.1007/s10067-018-3989-2] [PMID: 29411182]
[18]
Napolitano, M.; Costa, L.; Caso, F.; Megna, M.; Scarpa, R.; Balato, N.; Ayala, F.; Balato, A. Minimal disease activity in patients with psoriatic arthritis treated with ustekinumab: Results from a 24-week real-world study. Clin. Rheumatol., 2017, 36(7), 1589-1593.
[http://dx.doi.org/10.1007/s10067-017-3700-z] [PMID: 28567556]
[19]
Costa, L.; Ramonda, R.; Ortolan, A.; Favero, M.; Foti, R.; Visalli, E.; Rossato, M.; Cacciapaglia, F.; Lapadula, G.; Scarpa, R. Psoriatic arthritis and obesity: The role of anti-IL-12/IL-23 treatment. Clin. Rheumatol., 2019, 38(9), 2355-2362.
[http://dx.doi.org/10.1007/s10067-019-04663-6] [PMID: 31264033]
[20]
Mease, P.J.; McInnes, I.B.; Kirkham, B.; Kavanaugh, A.; Rahman, P.; van der Heijde, D.; Landewé, R.; Nash, P.; Pricop, L.; Yuan, J.; Richards, H.B.; Mpofu, S. FUTURE 1 Study Group. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N. Engl. J. Med., 2015, 373(14), 1329-1339.
[http://dx.doi.org/10.1056/NEJMoa1412679] [PMID: 26422723]
[21]
McInnes, I.B.; Mease, P.J.; Kirkham, B.; Kavanaugh, A.; Ritchlin, C.T.; Rahman, P.; van der Heijde, D.; Landewé, R.; Conaghan, P.G.; Gottlieb, A.B.; Richards, H.; Pricop, L.; Ligozio, G.; Patekar, M.; Mpofu, S. FUTURE 2 Study Group. 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(9999), 1137-1146.
[http://dx.doi.org/10.1016/S0140-6736(15)61134-5] [PMID: 26135703]
[22]
Thaçi, D.; Blauvelt, A.; Reich, K.; Tsai, T-F.; Vanaclocha, F.; Kingo, K.; Ziv, M.; Pinter, A.; Hugot, S.; You, R.; Milutinovic, M. 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(3), 400-409.
[http://dx.doi.org/10.1016/j.jaad.2015.05.013] [PMID: 26092291]
[23]
Coates, L.C.; Gladman, D.D.; Nash, P.; FitzGerald, O.; Kavanaugh, A.; Kvien, T.K.; Gossec, L.; Strand, V.; Rasouliyan, L.; Pricop, L.; Ding, K.; Jugl, S.M.; Gaillez, C. FUTURE 2 study group. Secukinumab provides sustained PASDAS-defined remission in psoriatic arthritis and improves health-related quality of life in patients achieving remission: 2-year results from the phase III FUTURE 2 study. Arthritis Res. Ther., 2018, 20(1), 272.
[http://dx.doi.org/10.1186/s13075-018-1773-y] [PMID: 30526678]
[24]
Mease, P.; van der Heijde, D.; Landewé, R.; Mpofu, S.; Rahman, P.; Tahir, H.; Singhal, A.; Boettcher, E.; Navarra, S.; Meiser, K.; Readie, A.; Pricop, L.; Abrams, K. 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(6), 890-897.
[25]
van der Heijde, D.; Mease, P.J.; Landewé, R.B.M.; Rahman, P.; Tahir, H.; Singhal, A.; Boettcher, E.; Navarra, S.; Zhu, X.; Ligozio, G.; Readie, A.; Mpofu, S.; Pricop, L. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology, 2020, 59(6), 1325-1334.
[http://dx.doi.org/10.1093/rheumatology/kez420] [PMID: 31586420]
[26]
Sondag, M.; Verhoeven, F.; Guillot, X.; Prati, C.; Wendling, D. Efficacy of new treatments for dactylitis of psoriatic arthritis: Update of literature review. Clin. Rheumatol., 2019, 38(2), 591-596.
[http://dx.doi.org/10.1007/s10067-018-4328-3] [PMID: 30328022]
[27]
Strand, V.; McInnes, I.; Mease, P.; Nash, P.; Thom, H.; Kalyvas, C.; Hunger, M.; Gandhi, K.; Pricop, L.; Jugl, S.; Choy, E. Matching-adjusted indirect comparison: Secukinumab versus infliximab in biologic-naive patients with psoriatic arthritis. J. Comp. Eff. Res., 2019, 8(7), 497-510.
[http://dx.doi.org/10.2217/cer-2018-0141] [PMID: 30806520]
[28]
Nash, P.; McInnes, I.B.; Mease, P.J.; Thom, H.; Hunger, M.; Karabis, A.; Gandhi, K.; Mpofu, S.; Jugl, S.M. secukinumab versus adalimumab for psoriatic arthritis: comparative effectiveness up to 48 weeks using a matching-adjusted indirect comparison. Rheumatol. Ther., 2018, 5(1), 99-122.
[http://dx.doi.org/10.1007/s40744-018-0106-6] [PMID: 29605841]
[29]
Kawalec, P.; Holko, P.; Moćko, P.; Pilc, A. Comparative effectiveness of abatacept, apremilast, secukinumab and ustekinumab treatment of psoriatic arthritis: A systematic review and network meta-analysis. Rheumatol. Int., 2018, 38(2), 189-201.
[http://dx.doi.org/10.1007/s00296-017-3919-7] [PMID: 29285605]
[30]
Reich, K.; Sullivan, J.; Arenberger, P.; Mrowietz, U.; Jazayeri, S.; Augustin, M.; Parneix, A.; Regnault, P.; You, R.; Milutinovic, M. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br. J. Dermatol., 2019, 181(5), 954-966.
[http://dx.doi.org/10.1111/bjd.17351] [PMID: 30367462]
[31]
Purmonen, T.; Puolakka, K.; Bhattacharyya, D.; Jain, M.; Martikainen, J. Cost-effectiveness analysis of secukinumab versus other biologics and apremilast in the treatment of active psoriatic arthritis: A finnish perspective. Cost Eff. Resour. Alloc., 2018, 16(1), 56.
[http://dx.doi.org/10.1186/s12962-018-0162-3] [PMID: 30479574]
[32]
Mease, P.J.; van der Heijde, D.; Ritchlin, C.T.; Okada, M.; Cuchacovich, R.S.; Shuler, C.L.; Lin, C-Y.; Braun, D.K.; Lee, C.H.; Gladman, D.D. xekizumab, 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 T. Ann. Rheum. Dis., 2017, 76(1), 79-87.
[33]
Coates, L.C.; Kishimoto, M.; Gottlieb, A.; Shuler, C.L.; Lin, C-Y.; Lee, C.H.; Mease, P.J. Ixekizumab efficacy and safety with and without concomitant conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active Psoriatic Arthritis (PsA): Results from SPIRIT-P1. RMD Open, 2017, 3(2)e000567
[http://dx.doi.org/10.1136/rmdopen-2017-000567] [PMID: 29299340]
[34]
Nash, P.; Kirkham, B.; Okada, M.; Rahman, P.; Combe, B.; Burmester, G-R.; Adams, D.H.; Kerr, L.; Lee, C.; Shuler, C.L.; Genovese, M.; Ahmed, K.; Alper, J.; Barkham, N.; Bennett, R.E.; García, F.J.B.; Alonso, R.B.; Blumstein, H.B.; Brooks, M.S.; Burmester, G-R.; Cagnoli, P.; Caldron, P.H.; Cantagrel, A.; Chen, D-Y.; Churchill, M.A., Jr; Codding, C.E.; Combe, B.; Deane, P.M.G.; Del Giudice, J.; Deodhar, A.A.; Dhar, R.K.; Dokoupilova, E.; Egan, R.M.; Everding, A.; Galíndez, E.; Genovese, M.; Goddard, D.H.; Gottlieb, A.; Goupille, P.; Griffin, R.M.; Gupta, R.C.; Hall, S.; Hatti, K.; Howell, M.P.; Huang, Y-H.; Jajoo, R.; Janssen, N.M.; Kiltz, U.; Kivitz, A.J.; Klein, S.J.; Korkosz, M.P.; Kotha, R.; Kremer, J.M.; Lue, C.; de la Fuente, J.L.M.; Marzo-Ortega, H.; Masmitja, J.G.; Mease, P.J.; Meroni, P.L.; Mueller, E.C.; Nandagudi, A.C.; Nash, P.; Fernández-Nebro, A.; Neuwelt, C.M.; Orbai, A.M.; Oza, M.R.; Parks, D.L.; Pattanaik, D.; Rell-Bakalarska, M.E.; Rosmarin, D.; Roussou, E.; Rychlewska-Hanczewksa, A.I.; Sikes, D.H.; Stack, M.T.; Sunkureddi, P.; Tahir, H.; Thaçi, D.; Tsai, T-F.; Turkiewicz, A.M.; Unger, L.; Cabello, R.V.; Wagner, U.; Wei, C-C.; Wells, A.F.; Youssef, P.; Zielinska, A. SPIRIT-P2 Study Group. 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(10086), 2317-2327.
[http://dx.doi.org/10.1016/S0140-6736(17)31429-0] [PMID: 28551073]
[35]
Nash, P.; Behrens, F.; Orbai, A-M.; Rathmann, S.S.; Adams, D.H.; Benichou, O.; Deodhar, A. Ixekizumab is efficacious when used alone or when added to conventional synthetic Disease-Modifying Antirheumatic Drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors. RMD Open, 2018, 4(2)e000692
[http://dx.doi.org/10.1136/rmdopen-2018-000692] [PMID: 30233812]
[36]
Gladman, D.D.; Orbai, A-M.; Klitz, U.; Wei, J.C-C.; Gallo, G.; Birt, J.; Rathmann, S.; Shrom, D.; Marzo-Ortega, H. Ixekizumab and complete resolution of enthesitis and dactylitis: Integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res. Ther., 2019, 21(1), 38.
[http://dx.doi.org/10.1186/s13075-019-1831-0] [PMID: 30696483]
[37]
Mease, P.; Roussou, E.; Burmester, G-R.; Goupille, P.; Gottlieb, A.; Moriarty, S.R.; Benichou, O.; Adams, D.H.; Xu, W.; Nash, P. Safety of ixekizumab in patients with psoriatic arthritis: Results from a pooled analysis of three clinical trials. Arthritis Care Res. (Hoboken), 2019, 71(3), 367-378.
[http://dx.doi.org/10.1002/acr.23738] [PMID: 30156760]
[38]
van der Heijde, D.; Gladman, D.D.; Kishimoto, M.; Okada, M.; Rathmann, S.S.; Moriarty, S.R.; Shuler, C.L.; Carlier, H.; Benichou, O.; Mease, P.J. 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(3), 367-377.
[39]
Mourad, A.; Gniadecki, R. Treatment of dactylitis and enthesitis in psoriatic arthritis with biologic agents: A systematic review and metaanalysis. J. Rheumatol., 2020, 47(1), 59-65.
[40]
Wu, D.; Yue, J.; Tam, L-S. Efficacy and safety of biologics targeting interleukin-6, -12/23 and -17 pathways for peripheral psoriatic arthritis: A network meta-analysis. Rheumatology (Oxford), 2018, 57(3), 563-571.
[http://dx.doi.org/10.1093/rheumatology/kex452] [PMID: 29244162]
[41]
Mease, P.J.; Smolen, J.S.; Behrens, F.; Nash, P.; Liu Leage, S.; Li, L.; Tahir, H.; Gooderham, M.; Krishnan, E.; Liu-Seifert, H.; Emery, P.; Pillai, S.G.; Helliwell, P.S. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann. Rheum. Dis., 2020, 79(1), 123-131.
[42]
Iznardo, H.; Puig, L. The safety of brodalumab for the treatment of psoriasis. Expert Opin. Drug Saf., 2020, 19(4), 365-372.
[http://dx.doi.org/10.1080/14740338.2020.1730326] [PMID: 32053396]
[43]
Mease, P.J.; Genovese, M.C.; Greenwald, M.W.; Ritchlin, C.T.; Beaulieu, A.D.; Deodhar, A.; Newmark, R.; Feng, J.; Erondu, N.; Nirula, A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N. Engl. J. Med., 2014, 370(24), 2295-2306.
[http://dx.doi.org/10.1056/NEJMoa1315231] [PMID: 24918373]
[44]
Brodalumab in Psoriatic Arthritis (PsA). 24-week results from the Phase III AMVISON-1 and -2 Trials. J. Am. Acad. Dermatol., 2019, 81(4), AB28.
[http://dx.doi.org/10.1016/j.jaad.2019.06.140]
[45]
Kulig, P.; Musiol, S.; Freiberger, S.N.; Schreiner, B.; Gyülveszi, G.; Russo, G.; Pantelyushin, S.; Kishihara, K.; Alessandrini, F.; Kündig, T.; Sallusto, F.; Hofbauer, G.F.L.; Haak, S.; Becher, B. IL-12 protects from psoriasiform skin inflammation. Nat. Commun., 2016, 7(1), 13466.
[http://dx.doi.org/10.1038/ncomms13466] [PMID: 27892456]
[46]
Blauvelt, A.; Papp, K.A.; Griffiths, C.E.M.; Randazzo, B.; Wasfi, Y.; Shen, Y-K.; Li, S.; Kimball, A.B. 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(3), 405-417.
[http://dx.doi.org/10.1016/j.jaad.2016.11.041] [PMID: 28057360]
[47]
Reich, K.; Armstrong, A.W.; Foley, P.; Song, M.; Wasfi, Y.; Randazzo, B.; Li, S.; Shen, Y-K.; Gordon, K.B. 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(3), 418-431.
[http://dx.doi.org/10.1016/j.jaad.2016.11.042] [PMID: 28057361]
[48]
Deodhar, A.; Gottlieb, A.B.; Boehncke, W-H.; Dong, B.; Wang, Y.; Zhuang, Y.; Barchuk, W.; Xu, X.L.; Hsia, E.C. CNTO1959PSA2001 study group. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: A randomised, double-blind, placebo-controlled, phase 2 study. Lancet, 2018, 391(10136), 2213-2224.
[http://dx.doi.org/10.1016/S0140-6736(18)30952-8] [PMID: 29893222]
[49]
Mease, P.J.; Rahman, P.; Gottlieb, A.B.; Kollmeier, A.P.; Hsia, E.C.; Xu, X.L.; Sheng, S.; Agarwal, P.; Zhou, B.; Zhuang, Y.; van der Heijde, D.; McInnes, I.B. Discover-2 study group. Guselkumab in biologic-naive patients with active psoriatic arthritis (Discover-2): A double-blind, randomised, placebo-controlled phase 3 trial. Lancet, 2020, 395(10230), 1126-1136.
[http://dx.doi.org/10.1016/S0140-6736(20)30263-4] [PMID: 32178766]
[50]
Deodhar, A.; Helliwell, P.S.; Boehncke, W-H.; Kollmeier, A.P.; Hsia, E.C.; Subramanian, R.A.; Xu, X.L.; Sheng, S.; Agarwal, P.; Zhou, B.; Zhuang, Y.; Ritchlin, C.T. Discover-1 Study Group. 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(10230), 1115-1125.
[http://dx.doi.org/10.1016/S0140-6736(20)30265-8] [PMID: 32178765]
[51]
Reich, K.; Papp, K.A.; Blauvelt, A.; Tyring, S.K.; Sinclair, R.; Thaçi, D.; Nograles, K.; Mehta, A.; Cichanowitz, N.; Li, Q.; Liu, K.; La Rosa, C.; Green, S.; Kimball, A.B. 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(10091), 276-288.
[http://dx.doi.org/10.1016/S0140-6736(17)31279-5] [PMID: 28596043]
[52]
Sinclair, R.; Thirthar Palanivelu, V. Tildrakizumab for the treatment of psoriasis. Expert Rev. Clin. Immunol., 2019, 15(1), 5-12.
[http://dx.doi.org/10.1080/1744666X.2019.1544493] [PMID: 30394141]
[53]
Mease, P.J.; Chohan, S.; Fructuoso, F.J.G.; Chou, R.C.; Nograles, K.E.; Mendelsohn, A.M.; Luggen, M.E. Randomised, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of tildrakizumab, a high-affinity anti-interleukin-23p19 monoclonal antibody, in patients with active psoriatic arthritis. Ann. Rheum. Dis., 2019, 78(2), 78-79.
[54]
Papp, K.A.; Blauvelt, A.; Bukhalo, M.; Gooderham, M.; Krueger, J.G.; Lacour, J-P.; Menter, A.; Philipp, S.; Sofen, H.; Tyring, S.; Berner, B.R.; Visvanathan, S.; Pamulapati, C.; Bennett, N.; Flack, M.; Scholl, P.; Padula, S.J. risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N. Engl. J. Med., 2017, 376(16), 1551-1560.
[http://dx.doi.org/10.1056/NEJMoa1607017] [PMID: 28423301]
[55]
Gordon, K.B.; Strober, B.; Lebwohl, M.; Augustin, M.; Blauvelt, A.; Poulin, Y.; Papp, K.A.; Sofen, H.; Puig, L.; Foley, P.; Ohtsuki, M.; Flack, M.; Geng, Z.; Gu, Y.; Valdes, J.M.; Thompson, E.H.Z.; Bachelez, H. 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(10148), 650-661.
[http://dx.doi.org/10.1016/S0140-6736(18)31713-6] [PMID: 30097359]
[56]
Noisette, A.; Hochberg, M.C. Abatacept for the treatment of adults with psoriatic arthritis: Patient selection and perspectives. Psoriasis (Auckl), 2018, 8, 31-39.
[http://dx.doi.org/10.2147/PTT.S146076] [PMID: 30035098]
[57]
Mease, P.; Genovese, M.C.; Gladstein, G.; Kivitz, A.J.; Ritchlin, C.; Tak, P.P.; Wollenhaupt, J.; Bahary, O.; Becker, J-C.; Kelly, S.; Sigal, L.; Teng, J.; Gladman, D. Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum., 2011, 63(4), 939-948.
[http://dx.doi.org/10.1002/art.30176] [PMID: 21128258]
[58]
Mease, P.J.; Gottlieb, A.B.; van der Heijde, D.; FitzGerald, O.; Johnsen, A.; Nys, M.; Banerjee, S.; Gladman, D.D. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann. Rheum. Dis., 2017, 76(9), 1550-1558.
[59]
Reed, M.; Crosbie, D. Apremilast in the treatment of psoriatic arthritis: A perspective review. Ther. Adv. Musculoskelet. Dis., 2017, 9(2), 45-53.
[http://dx.doi.org/10.1177/1759720X16673786] [PMID: 28255338]
[60]
Edwards, C.J.; Blanco, F.J.; Crowley, J.; Birbara, C.A.; Jaworski, J.; Aelion, J.; Stevens, R.M.; Vessey, A.; Zhan, X.; Bird, P. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: A phase III, randomised, controlled trial (PALACE 3). Ann. Rheum. Dis., 2016, 75(6), 1065-1073.
[61]
Cutolo, M.; Myerson, G.E.; Fleischmann, R.M.; Lioté, F.; Díaz-González, F.; Van den Bosch, F.; Marzo-Ortega, H.; Feist, E.; Shah, K.; Hu, C.; Stevens, R.M.; Poder, A. A phase III, randomized, controlled trial of apremilast in patients with psoriatic arthritis: Results of the PALACE 2 Trial. J. Rheumatol., 2016, 43(9), 1724-1734.
[62]
Kavanaugh, A.; Mease, P.J.; Gomez-Reino, J.J.; Adebajo, A.O.; Wollenhaupt, J.; Gladman, D.D.; Lespessailles, E.; Hall, S.; Hochfeld, M.; Hu, C.; Hough, D.; Stevens, R.M.; Schett, G. Treatment of psoriatic arthritis in a phase 3 randomised, Placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann. Rheum. Dis., 2014, 73(6), 1020-1026.
[63]
Kavanaugh, A.; Gladman, D.D.; Edwards, C.J.; Schett, G.; Guerette, B.; Delev, N.; Teng, L.; Paris, M.; Mease, P.J. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res. Ther., 2019, 21(1), 118.
[http://dx.doi.org/10.1186/s13075-019-1901-3] [PMID: 31077258]
[64]
Schwartz, D.M.; Bonelli, M.; Gadina, M.; O’Shea, J.J. Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases. Nat. Rev. Rheumatol., 2016, 12(1), 25-36.
[http://dx.doi.org/10.1038/nrrheum.2015.167] [PMID: 26633291]
[65]
Bechman, K.; Yates, M.; Galloway, J.B. The new entries in the therapeutic armamentarium: The small molecule JAK inhibitors. Pharmacol. Res., 2019, •••147104392
[http://dx.doi.org/10.1016/j.phrs.2019.104392] [PMID: 31401212]
[66]
Choy, E.H. Clinical significance of janus kinase inhibitor selectivity. Rheumatology (Oxford), 2019, 58(6), 953-962.
[http://dx.doi.org/10.1093/rheumatology/key339] [PMID: 30508136]
[67]
Mease, P.; Hall, S.; FitzGerald, O.; van der Heijde, D.; Merola, J.F.; Avila-Zapata, F.; Cieślak, D.; Graham, D.; Wang, C.; Menon, S.; Hendrikx, T.; Kanik, K.S. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N. Engl. J. Med., 2017, 377(16), 1537-1550.
[http://dx.doi.org/10.1056/NEJMoa1615975] [PMID: 29045212]
[68]
Gladman, D.; Rigby, W.; Azevedo, V.F.; Behrens, F.; Blanco, R.; Kaszuba, A.; Kudlacz, E.; Wang, C.; Menon, S.; Hendrikx, T.; Kanik, K.S. Tofacitinib for psoriatic arthritis in patients with an Inadequate Response to TNF Inhibitors. N. Engl. J. Med., 2017, 377(16), 1525-1536.
[http://dx.doi.org/10.1056/NEJMoa1615977] [PMID: 29045207]
[69]
Harigai, M. Growing evidence of the safety of jak inhibitors in patients with rheumatoid arthritis. Rheumatology, 2019, 58(Suppl. 1), i34-i42.
[http://dx.doi.org/10.1093/rheumatology/key287]
[70]
Dougados, M.; van der Heijde, D.; Chen, Y-C.; Greenwald, M.; Drescher, E.; Liu, J.; Beattie, S.; Witt, S.; de la Torre, I.; Gaich, C.; Rooney, T.; Schlichting, D.; de Bono, S.; Emery, P. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: Results from the RA-BUILD study. Ann. Rheum. Dis., 2017, 76(1), 88-95.
[71]
Taylor, P.C.; Keystone, E.C.; van der Heijde, D.; Weinblatt, M.E.; Del Carmen Morales, L.; Reyes Gonzaga, J.; Yakushin, S.; Ishii, T.; Emoto, K.; Beattie, S.; Arora, V.; Gaich, C.; Rooney, T.; Schlichting, D.; Macias, W.L.; de Bono, S.; Tanaka, Y. Baricitinib versus Placebo or adalimumab in rheumatoid arthritis. N. Engl. J. Med., 2017, 376(7), 652-662.
[http://dx.doi.org/10.1056/NEJMoa1608345] [PMID: 28199814]
[72]
Genovese, M.C.; Kremer, J.; Zamani, O.; Ludivico, C.; Krogulec, M.; Xie, L.; Beattie, S.D.; Koch, A.E.; Cardillo, T.E.; Rooney, T.P.; Macias, W.L.; de Bono, S.; Schlichting, D.E.; Smolen, J.S. Baricitinib in patients with refractory rheumatoid arthritis. N. Engl. J. Med., 2016, 374(13), 1243-1252.
[http://dx.doi.org/10.1056/NEJMoa1507247] [PMID: 27028914]
[73]
Keystone, E.C.; Genovese, M.C.; Schlichting, D.E.; de la Torre, I.; Beattie, S.D.; Rooney, T.P.; Taylor, P.C. Safety and efficacy of baricitinib through 128 weeks in an open-label, longterm extension study in patients with rheumatoid arthritis. J. Rheumatol., 2018, 45(1), 14-21.
[74]
Ruyssen-Witrand, A.; Perry, R.; Watkins, C.; Braileanu, G.; Kumar, G.; Kiri, S.; Nott, D.; Liu-Leage, S.; Hartz, S.; Sapin, C. Efficacy and safety of biologics in psoriatic arthritis: A systematic literature review and network meta-analysis. RMD Open, 2020, 6(1)e001117
[http://dx.doi.org/10.1136/rmdopen-2019-001117] [PMID: 32094304]
[75]
Blair, H.A. Secukinumab: A review in ankylosing spondylitis. Drugs, 2019, 79(4), 433-443.
[http://dx.doi.org/10.1007/s40265-019-01075-3] [PMID: 30793255]
[76]
Dougados, M.; Wei, J.C-C.; Landewé, R.; Sieper, J.; Baraliakos, X.; Van den Bosch, F.; Maksymowych, W.P.; Ermann, J.; Walsh, J.A.; Tomita, T.; Deodhar, A.; van der Heijde, D.; Li, X.; Zhao, F.; Bertram, C.C.; Gallo, G.; Carlier, H.; Gensler, L.S. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, Controlled Clinical Trials in Patients with Active Radiographic Axial Spondyloarthritis (COAST-V and COAST-W). Ann. Rheum. Dis., 2020, 79(2), 176-185.
[77]
Siebert, S.; Millar, N.L.; McInnes, I.B. Why did IL-23p19 inhibition fail in AS: A tale of tissues, trials or translation? Ann. Rheum. Dis., 2019, 78(8), 1015-1018.
[78]
Pagnini, C.; Pizarro, T.T.; Cominelli, F. Novel pharmacological therapy in inflammatory bowel diseases: Beyond anti-tumor necrosis factor. Front. Pharmacol., 2019, 10, 671.
[http://dx.doi.org/10.3389/fphar.2019.00671] [PMID: 31316377]
[79]
Salaffi, F.; Giacobazzi, G.; Di Carlo, M. Chronic pain in inflammatory arthritis: Mechanisms, metrology, and emerging targets-a focus on the JAK-STAT pathway. Pain Res. Manag., 2018, 20188564215
[http://dx.doi.org/10.1155/2018/8564215] [PMID: 29623147]
[80]
Deodhar, A.; Mease, P.J.; McInnes, I.B.; Baraliakos, X.; Reich, K.; Blauvelt, A.; Leonardi, C.; Porter, B.; Das Gupta, A.; Widmer, A.; Pricop, L.; Fox, T. Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: Integrated pooled clinical trial and post-marketing surveillance data. Arthritis Res. Ther., 2019, 21(1), 111.
[http://dx.doi.org/10.1186/s13075-019-1882-2] [PMID: 31046809]
[81]
Papp, K.A.; Merola, J.F.; Gottlieb, A.B.; Griffiths, C.E.M.; Cross, N.; Peterson, L.; Cioffi, C.; Blauvelt, A. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase IIb trial. J. Am. Acad. Dermatol., 2018, 79(2), 277-286.e10.
[http://dx.doi.org/10.1016/j.jaad.2018.03.037] [PMID: 29609013]
[82]
Glatt, S.; Baeten, D.; Baker, T.; Griffiths, M.; Ionescu, L.; Lawson, A.D.G.; Maroof, A.; Oliver, R.; Popa, S.; Strimenopoulou, F.; Vajjah, P.; Watling, M.I.L.; Yeremenko, N.; Miossec, P.; Shaw, S. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: Evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17f contributes to human chronic tissue inflammation. Ann. Rheum. Dis., 2018, 77(4), 523-532.
[83]
Smirnov, A.; Gaydukova, I.; Mazurov, V.; Erdes, S.; Dubinina, T.; Nesmeyanova, O.; Ilivanova, E.; Kundzer, A.; Soroka, N.; Eremeeva, A.; Chernyaeva, E.; Ivanov, R. FRI0412 spinal and sacroiliac joints inflammation in patients with radiographic axial spondyloarthritis treated with netakimab - 16-weeks results of multicenter, randomized, double-blind, placebo-controlled phase III astera study. Ann. Rheum. Dis., 2019, 78(2), 893-984.
[84]
Reich, K.; Rich, P.; Maari, C.; Bissonnette, R.; Leonardi, C.; Menter, A.; Igarashi, A.; Klekotka, P.; Patel, D.; Li, J.; Tuttle, J.; Morgan-Cox, M.; Edson-Heredia, E.; Friedrich, S.; Papp, K. AMAF investigators. Efficacy and safety of mirikizumab (LY3074828) in the treatment of moderate-to-severe plaque psoriasis: Results from a randomized phase II study. Br. J. Dermatol., 2019, 181(1), 88-95.
[http://dx.doi.org/10.1111/bjd.17628] [PMID: 30734266]
[85]
Kavanaugh, A.; Kremer, J.; Ponce, L.; Cseuz, R.; Reshetko, O.V.; Stanislavchuk, M.; Greenwald, M.; Van der Aa, A.; Vanhoutte, F.; Tasset, C.; Harrison, P. Filgotinib (GLPG0634/GS-6034), an oral selective jak1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: Results from a Randomised, Dose-Finding Study (DARWIN 2). Ann. Rheum. Dis., 2017, 76(6), 1009-1019.
[86]
Mease, P.; Coates, L.C.; Helliwell, P.S.; Stanislavchuk, M.; Rychlewska-Hanczewska, A.; Dudek, A.; Abi-Saab, W.; Tasset, C.; Meuleners, L.; Harrison, P.; Besuyen, R.; Van der Aa, A.; Mozaffarian, N.; Greer, J.M.; Kunder, R.; Van den Bosch, F.; Gladman, D.D. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): Results from a randomised, placebo-controlled, phase 2 trial. Lancet, 2018, 392(10162), 2367-2377.
[http://dx.doi.org/10.1016/S0140-6736(18)32483-8] [PMID: 30360969]
[87]
Burmester, G.R.; Kremer, J.M.; Van den Bosch, F.; Kivitz, A.; Bessette, L.; Li, Y.; Zhou, Y.; Othman, A.A.; Pangan, A.L.; Camp, H.S. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): A randomised, double-blind, placebo-controlled phase 3 trial. Lancet, 2018, 391(10139), 2503-2512.
[http://dx.doi.org/10.1016/S0140-6736(18)31115-2] [PMID: 29908669]
[88]
Genovese, M.C.; Fleischmann, R.; Combe, B.; Hall, S.; Rubbert-Roth, A.; Zhang, Y.; Zhou, Y.; Mohamed, M.F.; Meerwein, S.; Pangan, A.L. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): A double-blind, randomised controlled phase 3 trial. Lancet, 2018, 391(10139), 2513-2524.
[http://dx.doi.org/10.1016/S0140-6736(18)31116-4] [PMID: 29908670]
[89]
Banfield, C.; Scaramozza, M.; Zhang, W.; Kieras, E.; Page, K.M.; Fensome, A.; Vincent, M.; Dowty, M.E.; Goteti, K.; Winkle, P.J.; Peeva, E. The safety, tolerability, pharmacokinetics, and pharmacodynamics of a TYK2/JAK1 inhibitor (PF-06700841) in healthy subjects and patients with plaque psoriasis. J. Clin. Pharmacol., 2018, 58(4), 434-447.
[http://dx.doi.org/10.1002/jcph.1046] [PMID: 29266308]
[90]
Papp, K.; Gordon, K.; Thaçi, D.; Morita, A.; Gooderham, M.; Foley, P.; Girgis, I.G.; Kundu, S.; Banerjee, S. .Phase 2 trial of selective tyrosine kinase 2 inhibition in psoriasis. N. Engl. J. Med. 2018, 379(14), 1313-1321.
[http://dx.doi.org/10.1056/NEJMoa1806382] [PMID: 30205746]


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 22
ISSUE: 1
Year: 2021
Published on: 27 September, 2020
Page: [85 - 98]
Pages: 14
DOI: 10.2174/1389201021666200928095521
Price: $65

Article Metrics

PDF: 37
HTML: 2