668
Views
15
CrossRef citations to date
0
Altmetric
Review

Safety of treatment options for spondyloarthritis: a narrative review

, , , , &
Pages 475-486 | Received 17 Jan 2018, Accepted 02 Mar 2018, Published online: 14 Mar 2018

  • Khan MA, van der Linden SM. Undifferentiated spondyloarthropathies. Spine: State Art Rev. 1990;4:657–664.
  • Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011;377:2127–2137.
  • Olivieri I, D’Angelo S, Padula A, et al. Spondyloarthritis with Onset After Age 45. Curr Rheumatol Rep. 2013;15:374.
  • Rudwaleit M, van der Heijde D, Landewe R, et al. The development of assessment of spondyloarthritis international society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68:777–783.
  • Rudwaleit M, van der Heijde D, Landewe R, et al. The assessment of spondyloarthritis international society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann Rheum Dis. 2011;70:25–31.
  • Taurog JD, Chhabra A, Colbert RA. Ankylosing spondylitis and axial spondyloarthritis. N Engl J Med. 2016;374:2563–2574.
  • Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006;54:2665–2673.
  • Olivieri I, D’Angelo S, Padula A, et al. The challenge of early diagnosis of psoriatic arthritis. J Rheumatol. 2008;35:3–5.
  • D’Angelo S, Palazzi C, Gilio M, et al. Improvements in diagnostic tools for early detection of psoriatic arthritis. Expert Rev Clin Immunol. 2016;12:1209–1215.
  • Van den Berg R, Van Gaalen F, van der Helm-van Mil A, et al. Performance of classification criteria for peripheral spondyloarthritis and psoriatic arthritis in the Leiden Early Arthritis cohort. Ann Rheum Dis. 2012;71:1366–1369.
  • Smolen JS, Schöls M, Braun J, et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis. 2018;77:3–17.
  • Olivieri I, D’Angelo S, Palazzi C, et al. Advances in the management of psoriatic arthritis. Nat Rev Rheumatol. 2014;10:531–542.
  • Palazzi C, D’Angelo S, Gilio M, et al. Pharmacological therapy of spondyloarthritis. Expert Opin Pharmacother. 2015;16:1495–1504.
  • Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75:499–510.
  • Coates LC, Kavanaugh A, Mease PJ, et al. Group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol. 2016;68:1060–1071.
  • Olivieri I, D’Angelo S. Psoriatic arthritis in 2015: advancement continues in imaging, tight control and new drugs. Nat Rev Rheumatol. 2016;12:76–78.
  • Gossec L, Coates LC, de Wit M, et al. Management of psoriatic arthritis in 2016: a comparison of EULAR and GRAPPA recommendations. Nat Rev Rheumatol. 2016;12:743–750.
  • van der Heijde D, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76:978–991.
  • Kroon FP, van der Burg LR, Ramiro S, et al. Non-steroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis). Cochrane Database Syst Rev. 2015;7:CD010952.
  • Colebatch AN, Marks JL, Edwards CJ. Safety of non-steroidal anti-inflammatory drugs, including aspirin and paracetamol (acetaminophen) in people receiving methotrexate for inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, other spondyloarthritis). Cochrane Database Syst Rev. 2011;11:CD008872.
  • Poddubnyy D, van der Heijde D. Therapeutic controversies in spondyloarthritis: nonsteroidal anti-inflammatory drugs. Rheum Dis Clin North Am. 2012;38:601–611.
  • Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib long-term arthritis safety study. JAMA. 2000;284:1247–1255.
  • Laine L, Curtis SP, Cryer B, et al. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2007;369:465–473.
  • Schnitzer TJ, Burmester GR, Mysler E, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet. 2004;364:665–674.
  • van der Heijde D, Baraf HS, Ramos-Remus C, et al. Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty-two-week, randomized, controlled study. Arthritis Rheum. 2005;52:1205–1215.
  • Dougados M, Gueguen A, Nakache JP, et al. Ankylosing spondylitis: what is the optimum duration of a clinical study? A one year versus a 6 weeks non-steroidal anti-inflammatory drug trial. Rheumatology (Oxford). 1999;38:235–244.
  • Wanders A, Heijde D, Landewe R, et al. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial. Arthritis Rheum. 2005;52:1756–1765.
  • Coxib and traditional NSAID Trialists’ (CNT) Collaboration et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382:769–779.
  • Song IH, Poddubnyy DA, Rudwaleit M, et al. Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum. 2008;58:929–938.
  • Kristensen LE, Jakobsen AK, Askling J, et al. Safety of etoricoxib, celecoxib, and nonselective nonsteroidal antiinflammatory drugs in ankylosing spondylitis and other spondyloarthritis patients: a swedish national population-based cohort study. Arthritis Care Res (Hoboken). 2015;67:1137–1149.
  • Bakland G, Gran JT, Nossent JC. Increased mortality in ankylosing spondylitis is related to disease activity. Ann Rheum Dis. 2011;70:1921–1925.
  • Haroon NN, Paterson JM, Li P, et al. Patients with ankylosing spondylitis have increased cardiovascular and cerebrovascular mortality: a population-based study. Ann Intern Med. 2015;163:409–416.
  • Fendler C, Baraliakos X, Braun J. Glucocorticoid treatment in spondyloarthritis. Clin Exp Rheumatol. 2011;29(5 Suppl. 68):S139–S142.
  • Habib GS, Saliba W, Nashashibi M. Local effects of intra-articular corticosteroids. Clin Rheumatol. 2010;29:347–356.
  • Ursini F, D’Angelo S, Padula A, et al. Retrospective analysis of type 2 diabetes prevalence in a systemic sclerosis cohort from southern Italy: comment on “Reduced incidence of Type 1 diabetes and Type 2 diabetes in systemic sclerosis: A nationwide cohort study” by Tseng et al., Joint Bone Spine 2016;83:307-13. Joint Bone Spine. 2016 Oct;83(5):611–612.
  • Seror P, Pluvinage P, d’Andre FL, et al. Frequency of sepsis after local corticosteroid injection (an inquiry on 1160000 injections in rheumatological private practice in France). Rheumatology (Oxford). 1999;38:1272–1274.
  • Ravindran V, Scott DL, Choy EH. A systematic review and meta-analysis of efficacy and toxicity of disease modifying anti-rheumatic drugs and biological agents for psoriatic arthritis. Ann Rheum Dis. 2008;67:855–859.
  • Pereda CA, Nishishinya MB, Martínez López JA, et al. Efficacy and safety of DMARDs in psoriatic arthritis: a systematic review. Clin Exp Rheumatol. 2012;30:282–289.
  • Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451–485.
  • Strober BE, Menon K. Folate supplementation during methotrexate therapy for patients with psoriasis. J Am Acad Dermatol. 2005;53:652–659.
  • Whiting-O’Keefe QE, Fye KH, Sack KD. Methotrexate and histologic hepatic abnormalities: a meta-analysis. Am J Med. 1991;90:711–716.
  • Lie E, van der Heijde D, Uhlig T, et al. Effectiveness and retention rates of methotrexate in psoriatic arthritis in comparison with methotrexate-treated patients with rheumatoid arthritis. Ann Rheum Dis. 2010;69:671–676.
  • Curtis JR, Beukelman T, Onofrei A, et al. Elevated liver enzyme tests among patients with rheumatoid arthritis or psoriatic arthritis treated with methotrexate and/or leflunomide. Ann Rheum Dis. 2010;69:43–47.
  • Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795–810.
  • Kingsley GH, Kowalczyk A, Taylor H, et al. A randomized placebo-controlled trial of methotrexate in psoriatic arthritis. Rheumatology (Oxford). 2012;51:1368–1377.
  • Salliot C, van der Heijde D. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann Rheum Dis. 2009;68:1100–1104.
  • Costa L, Caso F, Del Puente A, et al. Incidence of malignancies in a cohort of psoriatic arthritis patients taking traditional disease modifying antirheumatic drug and tumor necrosis factor inhibitor therapy: an observational study. J Rheumatol. 2016;43:2149–2154.
  • Chen J, Lin S, Liu C. Sulfasalazine for ankylosing spondylitis. Cochrane Database Syst Rev. 2014;(11):CD004800.
  • Kaltwasser JP, Nash P, Gladman D, et al. For the Treatment of Psoriatic Arthritis Study Group. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: a multinational, double-blind, randomized, placebo-controlled clinical trial. Arthritis Rheum. 2004;50:1939–1950.
  • Behrens F, Finkenwirth C, Pavelka K, et al. Leflunomide in psoriatic arthritis: results from a large European prospective observational study. Arthritis Care Res. 2013;65:464–470.
  • Haibel H, Rudwaleit M, Braun J, et al. Six months open label trial of leflunomide in active ankylosing spondylitis. Ann Rheum Dis. 2005;64:124–126.
  • Van Denderen JC, van der Paardt M, Nurmohamed MT, et al. Double blind, randomised, placebo controlled study of leflunomide in the treatment of active ankylosing spondylitis. Ann Rheum Dis. 2005;64:1761–1764.
  • Chighizola CB, Ong VH, Meroni PL. The use of cyclosporine A in rheumatology: a 2016 comprehensive review. Clin Rev Allergy Immunol. 2017;52:401–423.
  • Fraser AD, van Kuijk AWR, Westhovens R, et al. A randomized, double blind, placebo controlled multicentre trial of combination therapy with methotrexate plus cyclosporin in patients with active psoriatic arthritis. Ann Rheum Dis. 2005;64:859–864.
  • Salvarani C, Macchioni P, Olivieri I, et al. A comparison of cyclosporine, sulfasalazine, and symptomatic therapy in the treatment of psoriatic arthritis. J Rheumatol. 2001;28:2274–2282.
  • Sarzi-Puttini P, Cazzola M, Panni B, et al. Long-term safety and efficacy of low-dose cyclosporin A in severe psoriatic arthritis. Rheumatol Int. 2002;21:234–238.
  • D’Angelo S, Cutro MS, Lubrano E, et al. Combination therapy with ciclosporin and etanercept in patients with psoriatic arthritis. Ann Rheum Dis. 2010;69:934–935.
  • Colombo D, Chimenti S, Grossi P, et al. Prevalence of past and reactivated viral infections and efficacy of cyclosporine A as monotherapy or in combination in patients with psoriatic arthritis—synergy study: a longitudinal observational study. BioMed Res Int. 2014;2014:941767.
  • Borigini MJ. Paulus HE Innovative treatment approaches for rheumatoid arthritis. Combination therapy. Baillieres Clin Rheumatol. 1995;9:689–710.
  • Pathan E, Abraham S, Van Rossen E, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in ankylosing spondylitis. Ann Rheum Dis. 2013;72:1475–1480.
  • Qu X, Zhang S, Tao L, et al. A meta-analysis of apremilast on psoriatic arthritis long-term assessment of clinical efficacy (PALACE). Expert Rev Clin Pharmacol. 2016;9:799–805.
  • Mease PJ, Adebajo AA, Gladman DD, et al. Long-term (104-week) safety profile of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: results from a Phase III, randomized, controlled trial and open-label extension. Arthritis Rheum. 2014;66(11 Suppl):S690.
  • Busa S, Kavanaugh A. Drug safety evaluation of apremilast for treating psoriatic arthritis. Expert Opin Drug Saf. 2015;14:979–985.
  • Committee for Medicinal Products for Human Use (CHMP). Apremilast. Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Conclusion/human/003746/WC500223459.pdf
  • Maxwell LJ, Zochling J, Boonen A, et al. TNF-alpha inhibitors for ankylosing spondylitis. Cochrane Database Syst Rev. 2015;(4):CD005468.
  • Lemos LL, de Oliveira Costa J, Almeida AM, et al. Treatment of psoriatic arthritis with anti-TNF agents: a systematic review and meta-analysis of efficacy, effectiveness and safety. Rheumatol Int. 2014;34:1345–1360.
  • Fénix-Caballero S, Alegre-Del Rey EJ, Castan ̃o-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;38:286–293.
  • Hellgren K, Dreyer L, Arkema EV, et al. Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: a collaborative study from the ARTIS and DANBIO registers. Ann Rheum Dis. 2017;76:105–111.
  • Chen Y, Sun J, Yang Y, et al. Malignancy risk of anti-tumor necrosis factor alpha blockers: an overview of systematic reviews and meta-analyses. Clin Rheumatol. 2016;35:1–18.
  • Cantini F, Niccoli L, Goletti D. Adalimumab, etanercept, infliximab, and the risk of tuberculosis: data from clinical trials, national registries, and postmarketing surveillance. J Rheumatol Suppl. 2014;91:47–55.
  • Palazzi C, D’Angelo S, Leccese P, et al. Safety of anti-tumor necrosis factor agents in psoriatic arthritis - an update. Expert Opin Drug Saf. 2014;13:191–196.
  • Selmi C, Ceribelli A, Naguwa SM, et al. Safety issues and concerns of new immunomodulators in rheumatology. Expert Opin Drug Saf.2015;14:389–399.
  • Wendling D, Prati C. Paradoxical effects of anti-TNF-α agents in inflammatory diseases. Expert Rev Clin Immunol. 2014;10:159–169.
  • Ciccarelli F, De Martinis M, Sirufo MM, et al. Psoriasis induced by anti-tumor necrosis factor alpha agents: a comprehensive review of the literature. Acta Dermatovenerol Croat. 2016;24:169–174.
  • D’Angelo S, Palazzi C, Olivieri I. Psoriatic arthritis: treatment strate-gies using biologic agents. Reumatismo. 2012;64:113–121.
  • D’Angelo S, Palazzi C, Cantini F, et al. Etanercept in spondyloarthopathies.Part II: safety and pharmacoeconomic issues. Clin Exp Rheumatol. 2011;29:865–870.
  • Deodhar A, Braun J, Inman RD, et al. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year result of the GO-RAISE study. Ann Rheum Dis. 2015;74:757–761.
  • 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;73:1689–1694.
  • Sieper J, Landewé R, Rudwaleit M, et al. Effect of certolizumab pegol over ninety-six weeks in patients with axial spondyloarthritis. Results from a phase III randomized trial. Arthritis Rheumatol. 2015;67:668–677.
  • Mease P, Deodhar A, Fleischmann R, et al. Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure. RMD Open. 2015;1:e000119.
  • Capogrosso Sansone A, Mantarro S, Tuccori M, et al. Safety profile of certolizumab pegol in patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis. Drug Saf. 2015;38:869–888.
  • McInnes IB, Kavanaugh A, Gottlieb AB, et al. 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;382:780–789.
  • Ritchlin C, Rahman P, Kavanaugh A, et al. 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;73:990–999.
  • Kavanaugh A, Puig L, Gottlieb AB, et al. Maintenance of clinical efficacy and radiographic benefit through two years of ustekinumab therapy in patients with active psoriatic arthritis: results from a randomized, placebo-controlled phase III trial. Arthritis Care Res (Hoboken). 2015;67:1739–1749.
  • Papp K, Gottlieb AB, Naldi L, et al. Safety surveillance for ustekinumab and other psoriasis treatments from the psoriasis longitudinal assessment and registry (PSOLAR). J Drugs Dermatol. 2015;14:706–714.
  • Papp KA, Griffiths CE, Gordon K, et al. PHOENIX 1 Investigators.; PHOENIX 2 Investigators.; ACCEPT Investigators. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013;168:844–854.
  • Baeten D, Baraliakos X, Braun J, et al. Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2013;382:1705–1713.
  • Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17a inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373:2534–2548.
  • Lubrano E, Perrotta FM. Secukinumab for ankylosing spondylitis and psoriatic arthritis. Ther Clin Risk Manag. 2016;12:1587–1592.
  • Baeten D, Braun J, Sieper J, et al. Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis: 2-year efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled trial [abstract no. 2896]. Arthritis Rheumatol. 2015;67(Suppl 10):3490–3492.
  • Blair HA, Dhillon S. Secukinumab: a review in ankylosing spondylitis. Drugs. 2016;76:1023–1030.
  • 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.
  • Mease P, McInnes IB. Secukinumab: a new treatment option for psoriatic arthritis. Rheumatol Ther. 2016;3:5–29.
  • Van De Kerkhof PC, Griffiths CE, Reich K, et al. Secukinumab long-term safety experience: a pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75:83–98.
  • Kavanaugh A, Mease PJ, Reimold AM, et al. Secukinumab for long-term treatment of psoriatic arthritis: 2-year follow-up from a phase 3, randomized, double-blind, placebo-controlled study. Arthritis Care Res (Hoboken). 2017;69:347–355.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.