Biological treatment of psoriatic arthritis

Czech version

Authors: Jiří Štolfa
Authors‘ workplace: Revmatologický ústav, Praha
Published in: Vnitř Lék 2018; 64(2): 127-135
Category: Reviews

Overview

Psoriatic arthritis (PsA) is a heterogeneous disease affecting, besides synovial joints, also the entheses, the soft tissues of the whole finger (dactylitis) and the axial skeleton. Currently the classification criteria CASPAR are used to diagnose PsA. In a large number of patients the disease leads to irreversible joint damage (X-ray, respectively clinical) which significantly reduces life quality and limits the patient in his/her everyday activities and also considerably limits their work capacity. There is evidence showing that early commencement of treatment and treat to target principle can significantly reduce this negative development. In recent time the knowledge of the disease pathogenesis has been extending and at the same time new drugs appear that act on the critical pathogenetic processes in a targeted way. These are biological drugs from the group of TNFα inhibitors and, most recently, also inhibitors of Th17 – IL17 pathway. Together with that is further specified the treatment strategy and the way of its monitoring. These new findings have led to the update of recommendations for the treatment and monitoring of psoriatic arthritis by the Czech Society for Rheumatology.

Key words:
biological drugs – conventional synthetic disease-modifying antirheumatic drugs – early treatment – psoriatic arthritis – targeted synthetic disease modifying drugs – treat to target

Sources

1. Wright V, Moll JM. Psoriatic arthritis. Bull Rheum Dis 1971; 21(5): 627–632.

2. Taylor W, Gladman D, Helliwell P et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheumatol 2006; 54(8): 2665–2673. Dostupné z DOI: <http://dx.doi.org/10.1002/art.21972>.

3. Ash Z, Gaujoux-Viala C, Gossec L, et al. A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis 2012; 71(3): 319–326. Dostupné z DOI: <http://dx.doi.org/10.1136/ard.2011.150995>.

4. Mumtaz A, Gallagher P, Kirby B et al. Development of a preliminary composite disease activity index in psoriatic arthritis. Ann Rheum Dis 2011; 70(2) :272–277. Dostupné z DOI: <http://dx.doi.org/10.1136/ard.2010.129379>.

5. Braun J, Sieper J. Role of novel biological therapies in psoriatic arthritis. Therapy review. Biodrugs 2003; 17(3): 187–199.

6. Antoni CE, Kavanaugh A, Kirkham B et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheumatol 2005; 52(4): 1227–1236. Dostupné z DOI: <http://dx.doi.org/10.1002/art.20967>. Erratum in Arthritis Rheumatol. 2005; 52(9): 2951.

7. Reich K, Nestle FO, Papp K et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blindtrial. Lancet 2005; 366(9494): 1367–1374.

8. Gottlieb AB, Kalb RE, Blauvelt A et al. The efficacy and safety of infliximab inpatients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study. J Am Acad Dermatol 2012; 67(4): 642–650. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jaad.2011.10.020>.

9. Kavanaugh A, Krueger GG, Beutler A et al. Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial. Ann Rheum Dis 2007; 66(4): 498–505. Dostupné z DOI: <http://dx.doi.org/10.1136/ard.2006.058339>.

10. van der Heijde D, Kavanaugh A, Gladman DD et al. Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through 1 year of treatment: results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis Rheumatol 2007; 56(8): 2698–2707. Dostupné z DOI: <http://dx.doi.org/10.1002/art.22805>.

11. Sterry W, Ortonne JP, Kirkham B et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ 2010; 340: c147. Dostupné z DOI: <http://dx.doi.org/10.1136/bmj.c147>.

12. Mease PJ, Kivitz AJ, Burch FX et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheumatol 2004; 50(7): 2264–2272. Dostupné z DOI: <http://dx.doi.org/10.1002/art.20335>.

13. Mease PJ, Kivitz AJ, Burch FX et al. Continued inhibition of radiographic progression inpatients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol 2006; 33(4): 712–721.

14. Ash Z, Gaujoux-Viala C, Gossec L et al. A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis 2012; 71(3):319–326. Dostupné z DOI: <http://dx.doi.org/10.1136/ard.2011.150995>.

15. Crowley JJ, Weinberg JM, Wu JJ et al. Treatment of nail psoriasis: best practice recommendations from the medical board of the national psoriasis foundation. JAMA Dermatol 2015; 151(1): 87–94. Dostupné z DOI: <http://dx.doi.org/10.1001/jamadermatol.2014.2983>.

16. Baker DE. Adalimumab: Human recombinant imunoglobulin G1 anti-tumour necrosis factor monoclonal antibody. Rev Gastroenterol Disord 2004; 48(4): 196–210.

17. Gladman DD, Mease PJ, Cifaldi MA et al. Adalimumab improves joint-related and skin related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the adalimumab effectiveness in psoriatic arthritis trial. Ann Rheum Dis 2007; 66(2): 163–168. Dostupné z DOI: <http://dx.doi.org/10.1136/ard.2006.057901>.

18. Fenix-Caballero S, Alegre-del Rey EJ, Castano-Lara R et al. Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in Psoriatic arthritis. J Clin Pharm Ther 2013; 38(4): 286–293. Dostupné z DOI: <http://dx.doi.org/10.1111/jcpt.12045>.

19. Thorlund K, Druyts E, Avina-Zubieta JA et al. Anti-tumor necrosis factor (TNF) drugs for the treatment of Psoriatic arthritis: an indirect comparison meta-analysis. Biologics 2012; 6: 417–427. Dostupné z DOI: <http://dx.doi.org/10.2147/BTT.S37606>. Erratum in Biologics 2014; 8: 57–58.

20. Fagerli KM, Lie E, van der Heijde D et al. Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study. Ann Rheum Dis 2013; 72(11): 1840–1844. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2012–203018>.

21. Glintborg B, Ostergaard M, Krogh NS et al. Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor alpha inhibitor therapy: results from the Danish Nationwide DANBIO registry. Arthritis Rheumatol 2013; 65(5): 1213–1223. Dostupné z DOI: <http://dx.doi.org/10.1002/art.37876>.

22. Braun J, Sieper J. Role of novel biological therapies in psoriatic arthritis. Therapy review. Biodrugs 2003; 17(3): 187–199.

23. Kavanaugh A, McInnes I, Mease P et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every 4 weeks as a subcutaneous injection in psoriatic arthritis: 24-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheumatol 2009; 60(4): 976–986. Dostupné z DOI: <http://dx.doi.org/10.1002/art.24403>. Erratum in Arthritis Rheumatol 2010; 62(8): 2555.

24. Kavanaugh A, McInnes IB, Mease P et al. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Ann Rheum Dis 2014; 73(9):1689–1694. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2013–204902>.

25. Kavanaugh A, Mease P. Treatment of psoriatic arthritis with tumor necrosis factor inhibitors: longer-term outcomes including enthesitis and dactylitis with golimumab treatment in the long term extension of a randomized, placebo-controlled study (GO-REVEAL). J Rheumatol Suppl 2012; 89: 90–93. Dostupné z DOI: <http://dx.doi.org/10.3899/jrheum.120254>.

26. Rozenblit M, Lebwohl M. New biologics for psoriasis and psoriatic arthritis. Dermatol Ther 2009; 22(1): 56–60. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1529–8019.2008.01216.x>.

27. Reich K, Ortonne JP, Gottlieb AB et al Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab’ certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol 2012; 167(1): 180–190. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1365–2133.2012.10941.x>.

28. Mease PJ, Fleischmann R, Wollenhaupt J et al. Effect of certolizumab pegol over 48 weeks on signs and symptoms in patients with Psoriatic arthritis with and without prior tumor necrosis factor inhibitor exposure. Rheumatology 2014; 53(Suppl 1): i137-i138. Dostupné z DOI: <https://doi.org/10.1093/rheumatology/keu115.004>.

29. Mease PJ, Fleischmann R, Deodhar AA et al. Effect of certolizumab pegol on signsand symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study(RAPID-PsA). Ann Rheum Dis 2014; 73(1): 48–55. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2013–203696>.

30. van der Heijde D, Fleischmann R, Wollenhaupt J et al. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis 2014; 73(1): 233–237. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2013–203697>.

31. Gladman D, Fleischmann R, Coteur G et al. Effect of certolizumab pegol on multiple facets of Psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res 2014; 66(7): 1085–1092. Dostupné z DOI: <http://dx.doi.org/10.1002/acr.22256>.

32. Kavanaugh A, Gladman D, van der Heijde D et al. Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study. Ann Rheum Dis 2015; 74(1): 44–51. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2014–205198>.

33. Young MS, Horn EJ, Cather JC. The ACCEPT study: ustekinumab versus etanercept in moderate-to-severe psoriasis patients. Expert Rev Clin Immunol 2011; 7(1): 9–13. Dostupné z DOI: <http://dx.doi.org/10.1586/eci.10.92>.

34. Ritchlin CT, Gottlieb AB, McInnes IB et al. Ustekinumab in active psoriatic arthritis including patients previously treated with anti-TNF agents: results of a phase 3, multicenter, double blind, placebo-controlled study [abstract 2557]. Arthritis Rheumatol 2012; 64(10 Suppl): S1080-S1081. Dostupné z DOI: <http://dx.doi.10.1002/art.37735>.

35. Ritchlin C, Rahman P, Kavanaugh A et al. [PSUMMIT 2 Study Group]. 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, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis 2014; 73(6): 990–999. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2013–204655>.

36. Ramiro S, Smolen JS, Landewé R et al. Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis 2016; 75(3): 490–498. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2015–208466>.

37. Kavanaugh A, Ritchlin C, Rahman P et al. 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-controlled PSUMMIT-1 and PSUMMIT-2trials. Ann Rheum Dis 2014; 73(6): 1000–1006. Dostupné z DOI: <http://dx.doi.org/10.1136/annrheumdis-2013–204741>.

38. Araujo E, Englbrecht M, Hoepken S et al. Ustekinumab is superior to TNF inhibitor treatment in resolving enthesitis in PSA patients with active enthesitis – results from the enthesial clearance in psoriatic arthritis (ECLIPSA) study. An Revm Dis 2017; 76(Suppl 2): 142. Dostupné z DOI: <http://dx.doi. 10.1136/annrheumdis-2017-eular.5398 >.

39. Kavanaugh A, Menter A, Mendelsohn A et al. Effect of ustekinumab on physical function and health-related quality of life in patients with psoriatic arthritis: a randomized, placebo-controlled, phase II trial. Curr Med Res Opin 2010; 26(10): 2385–2392. Dostupné z DOI: <http://dx.doi.org/10.1185/03007995.2010.515804>.

40. Noordenbos T, Yeremenko N, Gofita I et al. Interleukin-17-positive mast cells contribute to synovial inflammation in spondylarthritis. Arthritis Rheumatol 2012; 64(1): 99–109. Dostupné z DOI: <http://dx.doi.org/10.1002/art.33396>.

41. Philip Mease P, McInnes IB. Secukinumab: A New Treatment Option for Psoriatic Arthritis. Rheumatol Ther 2016; 3(1): 5–29. Dostupné z DOI: <http://dx.doi.org/10.1007/s40744–016–0031–5>.

42. Langley RG, Elewski BE, Lebwohl M et al. Secukinumab in plaque psoriasis – results of two phase 3 trials. N Engl J Med 2014; 371(4): 326–338. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1314258>.

43. Mease PJ, van der Heijde D, Ritchlin CT et al. A Randomized, double-blind, active- and placebo-controlled phase 3 study of efficacy and safety of ixekizumab, adalimumab, and placebo therapy in patients naïve to biologic disease modifying anti-rheumatic drugs with active psoriatic arthritis. 2015 ACR/ARHP Annual Meeting. ABSTRACT NUMBER: 977. Arthritis Rheumatol 2015; 67(Suppl 10). Dostupné z WWW: <http://acrabstracts.org/abstract/a-randomized-double-blind-active-and-placebo-controlled-phase-3-study-of-efficacy-and-safety-of-ixekizumab-adalimumab-and-placebo-therapy-in-patients-naive-to-biologic-disease-modifying-anti/>.

44. Schafer PH, Parton A, Gandhi AK et al. Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Parmacol 2010; 159(4): 842–855. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1476–5381.2009.00559.x>.

45. Schett G, Wollenhaupt J, Papp K et al. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheumatol 2012; 64(10): 3156–3167. Dostupné z DOI: <http://dx.doi.org/10.1002/art.34627>.

46. Kavanaugh A, Mease PJ, Gomez-Reino JJ et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: results of a phase 3, randomized, controlled trial [abstract L13]. Arthritis Rheumatol 2012; 64(Suppl 10): 4172–4173. Dostupné z DOI: <http://dx.doi.10.1002/art.37735>.

47. Celgene International Sarl. Apremilast achieves statistical significance for the primary endpoint of the first phase III study (PALACE-1) in patients with psoriatic arthritis. [Press release]. 2012. Dostupné z WWW: <http://ir.celgene.com/releasedetail.cfm?releaseid=795226>.

48. Fleischman R, Kremer J, Cush J et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012; 367(6): 495–507.

49. Ghoreshi K, Laurence A, O´Shia JJ. Janus kinases in immune cell signaling. Immunol Rev 2009; 228(1): 273–287. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1600–065X.2008.00754.x>.

50. Papp KA, Menter A, Strober B et al. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a phase 2b randomized placebo-controlled dose ranging study. Br J Dermatol 2012; 167(3): 668–677. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1365–2133.2012.11168.x>.

51. Štolfa J, Vencovský, J, Pavelka K. Doporučené léčebné postupy pro psoriatickou artritidu. Čes Revmatol 2016; 24(4): 142–152.