04 apr 2024

Provtagning och kontroller vid antireumatisk behandling

Sammanfattning

Rekommendation från Svensk Reumatologisk Förening 2024.

Arbetsgrupp: Karin Bengtsson, Francesca Faustini*, Meliha C. Kapetanovic, Karin Bolin, Johanna Sundbaum
*huvudansvarig för denna rekommendation

Dokumentet är baserat på en sammanvägning av genomgång av aktuella FASS texter och studier (varav ett urval finns som referenser nedan), klinisk erfarenhet och slutligen vid behov konsensusförfarande.

Rekommendationen ska ses som ett stöd för utformande av lokala kontrollrutiner. I tabellform anges de prover som bör analyseras baserat på respektive preparats säkerhetsprofil. Individuell anpassning baserat på komorbiditet m.m. görs efter behov. I övrigt analyseras givetvis diagnosspecifika prover och prover för effektutvärdering med individuellt anpassade intervall (oftast vid återbesök).

Läkemedlen är uppdelade i grupperna konventionella syntetiska DMARDs, biologiska DMARDs och målinriktade syntetiska DMARDs. Inom varje grupp är läkemedlen ordnade i bokstavsordning baserat på generiskt namn. Rekommendationerna gäller för alla generiska preparat och biosimilarer till listade originalpreparat.

Innehåll

Konventionella syntetiska DMARDs (csDMARDs)/immunmodulerande läkemedel

Biologiska DMARDs (bDMARDs) inkluderande biosimilarer

Målinriktade syntetiska DMARDs (tsDMARDs)

Referenser

Referenser

Sammanställningar/flera läkemedel i samma studie

Simms RW. Guidelines for monitoring drug therapy in Reumatoid Arthritis. Arthritis and Rheumatism. 1996;39(5):723-31.

Aletaha D, Smolen JS. Laboratory testing in rheumatoid arthritis patients taking disease-modifying antirheumatic drugs: clinical evaluation and cost analysis. Arthritis Rheum. 2002 Apr 15;47(2):181-8.

Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2012. Ann Rheum Dis. 2013 Apr;72 Suppl 2:ii2-34.

Pego-Reigosa JM, Cobo-Ibanez T, Calvo-Alen J, et al. Efficacy and safety of nonbiologic immunosuppressants in the treatment of nonrenal systemic lupus erythematosus: a systematic review. Arthritis Care Res (Hoboken). 2013 Nov;65(11):1775-85.

Ramiro S, Gaujoux-Viala C, Nam JL, et al. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2014 Mar;73(3):529-35.

Roubille C, Haraoui B. Interstitial lung diseases induced or exacerbated by DMARDS and biologic agents in rheumatoid arthritis: a systematic literature review. Semin Arthritis Rheum. 2014 Apr;43(5):613-26.

Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509.

Takase K, Horton SC, Ganesha A, et al. What is the utility of routine ANA testing in predicting development of biological DMARD-induced lupus and vasculitis in patients with rheumatoid arthritis? Data from a single-centre cohort. Ann Rheum Dis. 2014 Sep;73(9):1695-9.
Singh JA, Saag KG, Bridges SL, Jr., et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & rheumatology (Hoboken, NJ). 2015.

Ramiro S, Smolen JS, Landewe 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: 490-8.

Ai JW, Zhang S, Ruan QL, et al. The Risk of Tuberculosis in Patients with Rheumatoid Arthritis Treated with Tumor Necrosis Factor-alpha Antagonist: A Metaanalysis of Both Randomized Controlled Trials and Registry/Cohort Studies. J Rheumatol. 2015; 42: 2229-37.

Caso F, Del Puente A, Peluso R, et al. Emerging drugs for psoriatic arthritis. Expert opinion on emerging drugs. 2016; 21: 69-79.

Song GG, Lee YH. Relative efficacy and safety of apremilast, secukinumab, and ustekinumab for the treatment of psoriatic arthritis. Zeitschrift fur Rheumatologie. 2017.

Schlesinger N. The safety of treatment options available for gout. Expert Opin Drug Saf. 2017;16(4):429-36.

Andrès E, et al. State of Art of Idiosyncratic Drug-Induced Neutropenia or Agranulocytosis, with a Focus on Biotherapies. J Clin Med. 2019 Sep 1;8(9).

Konventionella syntetiska DMARDs (csDMARDs)/immunmodulerande läkemedel

Azatioprin
Booth RA, Ansari MT, Tricco AC, et al. Assessment of thiopurine methyltransferase activity in patients prescribed azathioprine or other thiopurine-based drugs. Evid Rep Technol Assess (Full Rep). 2010 Dec(196):1-282.

Kim MJ, Choe YH. Monitoring and safety of azathioprine therapy in inflammatory bowel disease. Pediatr Gastroenterol Hepatol Nutr. 2013 Jun;16(2):65-70.

Broekman MMTJ, Coenen MJH, Wanten GJ, et al. Risk factors for thiopurine-induced myelosuppression and infections in inflammatory bowel disease patients with a normal TPMT genotype. Aliment Pharmacol Ther. 2017 Nov;46(10):953-963.

Kolkicin
Cocco G, Chu DC, Pandolfi S. Colchicine in clinical medicine. A guide for internists. Eur J Intern Med. 2010 Dec;21(6):503-8.

Richette P, Bardin T. Colchicine for the treatment of gout. Expert Opin Pharmacother. 2010 Dec;11(17):2933-8.

Stamp LK. Safety profile of anti-gout agents: an update. Curr Opin Rheumatol. 14 Mar;26(2):162-8.

Leflunomid
Bird P, Griffiths H, Tymms K, et al. The SMILE study — safety of methotrexate in combination with leflunomide in rheumatoid arthritis. J Rheumatol. 2013 Mar;40(3):228-35.

Keen HI, Conaghan PG, Tett SE. Safety evaluation of leflunomide in rheumatoid arthritis. Expert Opin Drug Saf. 2013 Jul;12(4):581-8.

Ying S, Xiaomeng C, Xiaomin D, et al. Efficacy and safety of leflunomide versus cyclophosphamide for initial-onset Takayasu arteritis: a prospective cohort study. Ther Adv Musculoskelet Dis. 2020;12:1759720X20930114. Published 2020 Jun 2. Metotrexate

Yazici Y, Erkan D, Paget SA. Monitoring methotrexate hepatic toxicity in rheumatoid arthritis: is it time to update the guidelines? J Rheumatol. 2002 Aug;29(8):1586-9.

Yazici Y. Long-term safety of methotrexate in the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2010 Sep-Oct;28(5 Suppl 61):S65-7.

Colebatch AN, Marks JL, van der Heijde DM, Edwards CJ. Safety of nonsteroidal antiinflammatory drugs and/or paracetamol in people receiving methotrexate for inflammatory arthritis: a Cochrane systematic review. J Rheumatol Suppl. 2012 Sep;90:62-73.

Islam MN, Hossain M, Haq SA, et al. Efficacy and safety of methotrexate in articular and cutaneous manifestations of systemic lupus erythematosus. Int J Rheum Dis. 2012 Feb;15(1):62-8.

Romao VC, Lima A, Bernardes M, Canhao H, Fonseca JE. Three decades of low-dose methotrexate in rheumatoid arthritis: Can we predict toxicity? Immunol Res. 2014 Nov 13.

West J, Ogston S and Foerster J. Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials. PloS one. 2016; 11: e0153740.

Mycofenolatmofetil
Matsui K, Shibagaki Y, Sasaki H, et al. Mycophenolate mofetil-induced agranulocytosis in a renal transplant recipient. Clin Exp Nephrol. 2010 Dec;14(6):637-40.

Levine AB, Erkan D. Clinical assessment and management of cytopenias in lupus patients. Curr Rheumatol Rep. 2011 Aug;13(4):291-9.

Boddana P, Webb LH, Unsworth J, et al. Hypogammaglobulinemia and bronchiectasis in mycophenolate mofetil-treated renal transplant recipients: an emerging clinical phenomenon? Clin Transplant. 2011 May-Jun;25(3):417-9.

Sulfasalazin
Wadelius M, Eriksson N, Kreutz R, Bondon-Guitton E, Ibañez L, Carvajal A, Lucena MI, Sancho Ponce E, Molokhia M, Martin J, Axelsson T, Kohnke H, Yue QY, Magnusson PKE, Bengtsson M, Hallberg P; EuDAC. Sulfasalazine-Induced Agranulocytosis Is Associated With the Human Leukocyte Antigen Locus. Clin Pharmacol Ther. 2018 May;103(5):843-853.

Takrolimus
Mok CC, Ying KY, Yim CW, et al. Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. Ann Rheum Dis. 2016;75(1):30-36.

Liu Z, Zhang H, Liu Z, et al. Multitarget therapy for induction treatment of lupus nephritis: a randomized trial. Ann Intern Med. 2015;162(1):18-26.

Takeuchi T, Wakasugi N, Uno S, Makino H. Long-term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis: 5-year Interim Postmarketing Surveillance Study in Japan (TRUST). J Rheumatol. 2021 Jan 1;48(1):74-81. doi: 10.3899/jrheum.191008. Epub 2020 Apr 1. PMID: 32238515.

Voklosporin
Rovin BH, Teng YKO, Ginzler EM, Arriens C, Caster DJ, Romero-Diaz J, Gibson K, Kaplan J, Lisk L, Navarra S, Parikh SV, Randhawa S, Solomons N, Huizinga RB. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070-2080. doi: 10.1016/S0140-6736(21)00578-X. Epub 2021 May 7. Erratum in: Lancet. 2021 May 29;397(10289):2048. PMID: 33971155.

Saxena A, Ginzler EM, Gibson K, Satirapoj B, Santillán AEZ, Levchenko O, Navarra S, Atsumi T, Yasuda S, Chavez-Perez NN, Arriens C, Parikh SV, Caster DJ, Birardi V, Randhawa S, Lisk L, Huizinga RB, Teng YKO. Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial. Arthritis Rheumatol. 2023 Jul 19. doi: 10.1002/art.42657. Epub ahead of print. PMID: 37466424Arriens C, Teng YKO, Ginzler EM, Parikh SV, Askanase AD, Saxena A, Gibson K, Caster DJ, Atsumi T, Lisk L, Randhawa S, Gluck R, Solomons N, Huizinga RB. Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis. Arthritis Care Res (Hoboken). 2023 Jul;75(7):1399-1408. doi: 10.1002/acr.25007. Epub 2023 Feb 12. PMID: 36039949.

Biologiska DMARDs (bDMARDs) inkluderande biosimilarer:

Abatacept
Atzeni F, Sarzi-Puttini P, Mutti A, et al. Long-term safety of abatacept in patients with rheumatoid arthritis. Autoimmun Rev. 2013 Oct;12(12):1115-7.

Westhovens R, Kremer JM, Emery P, et al. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):553-62.

Simon TA, Soule BP, Hochberg M, et al. Safety of Abatacept Versus Placebo in Rheumatoid Arthritis: Integrated Data Analysis of Nine Clinical Trials. ACR Open Rheumatol. 2019 May 29;1(4):251-257.

Anakinra
Nuki G, Bresnihan B, Bear MB, McCabe D. Long-term safety and maintenance of clinical improvement following treatment with anakinra (recombinant human interleukin-1 receptor antagonist) in patients with rheumatoid arthritis: extension phase of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2002 Nov;46(11):2838-46.

Fleischmann RM, Schechtman J, Bennett R, et al. Anakinra, a recombinant human interleukin-1 receptor antagonist (r-metHuIL-1ra), in patients with rheumatoid arthritis: A large, international, multicenter, placebo-controlled trial. Arthritis Rheum. 2003 Apr;48(4):927-34.

Fleischmann RM, Tesser J, Schiff MH, et al. Safety of extended treatment with anakinra in patients with rheumatoid arthritis. Ann Rheum Dis. 2006 Aug;65(8):1006-12.

Anifrolumab
Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18. PMID: 31851795.

Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11. PMID: 36369793; PMCID: PMC10098934.

Belimumab
Wallace DJ, Navarra S, Petri MA, et al. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54.

Ginzler EM, Wallace DJ, Merrill JT, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9.

Hui-Yuen JS, Reddy A, Taylor J, et al. Safety and Efficacy of Belimumab to Treat Systemic Lupus Erythematosus in Academic Clinical Practices. J Rheumatol. 2015; 42: 2288-95.

Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL; Groark J, Sthol W, Kleoudis C, Roth D. A 6-month open-label extension study of safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus (2018) 27: 1489-1498.

van Vollenhoven RF, Navarra SV, Levy RA, et al. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020;59(2):281-291.

Tanaka Y, Bae SC, Bass D, Curtis P, Chu M, DeRose K, Ji B, Kurrasch R, Lowe J, Meizlik P, Roth DA. Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea. RMD Open. 2021 Jul;7(2):e001629. doi: 10.1136/rmdopen-2021-001629. PMID: 34215703; PMCID: PMC8256836.

Bimekizumab
Ritchlin CT, Coates LC, McInnes IB, Mease PJ, Merola JF, Tanaka Y, Asahina A, Gossec L, Gottlieb AB, Warren RB, Ink B, Bajracharya R, Shende V, Coarse J, Landewé RB. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023 Nov;82(11):1404-1414. doi: 10.1136/ard-2023-224431. Epub 2023 Sep 11. PMID: 37696588; PMCID: PMC10579478.

Merola JF, Landewé R, McInnes IB, Mease PJ, Ritchlin CT, Tanaka Y, Asahina A, Behrens F, Gladman DD, Gossec L, Gottlieb AB, Thaçi D, Warren RB, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Coates LC. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023 Jan 7;401(10370):38-48. doi: 10.1016/S0140-6736(22)02303-0. Epub 2022 Dec 6. PMID: 36495881.

Guselkumab
Deodhar A, Helliwell PS, Boehncke WH, Kollmeier AP, Hsia EC, Subramanian RA, Xu XL, Sheng S, Agarwal P, Zhou B, Zhuang Y, Ritchlin CT; 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 Apr 4;395(10230):1115-1125. doi: 10.1016/S0140-6736(20)30265-8. Epub 2020 Mar 13. Erratum in: Lancet. 2020 Apr 4;395(10230):1114. PMID: 32178765.

Ritchlin CT, Helliwell PS, Boehncke WH, Soriano ER, Hsia EC, Kollmeier AP, Chakravarty SD, Zazzetti F, Subramanian RA, Xu XL, Zuraw QC, Sheng S, Jiang Y, Agarwal P, Zhou B, Zhuang Y, Shawi M, Karyekar CS, Deodhar A. Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced. RMD Open. 2021 Feb;7(1):e001457. doi: 10.1136/rmdopen-2020-001457. PMID: 33568556; PMCID: PMC7880108.

Ixekizumab
Genovese MC, Combe B, Kremer JM, Tsai T-F, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Saftey and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford) 2018; 57: 2001-2011.

Deodhar A, van der Heijde D, Gensler LS, et al. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. doi:10.1016/S0140-6736(19)32971-X

Dougados M, Wei JC, Landewé R, et al. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, andomized, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) [published correction appears in Ann Rheum Dis. 2020 Jun;79(6):e75]. Ann Rheum Dis. 2020;79(2):176-185.

Mease PJ, Smolen JS, Behrens F, et al. 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.

Risankizumab
Östör A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Alperovich G, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2021 Nov 23:annrheumdis-2021-221048. doi: 10.1136/annrheumdis-2021-221048. Epub ahead of print. PMID: 34815219.

Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022 Feb;81(2):225-231. doi: 10.1136/annrheumdis-2021-221019. Epub 2021 Dec 15. PMID: 34911706; PMCID: PMC8762015.

Rituximab
Gottenberg JE, Ravaud P, Bardin T, et al. Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum. 2010 Sep;62(9):2625-32.

van Vollenhoven RF, Emery P, Bingham CO, 3rd, et al. Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients. Ann Rheum Dis. 2013 Sep 1;72(9):1496-502.

Heusele M, Clerson P, Guery B, et al. Risk factors for severe bacterial infections in patients with systemic autoimmune diseases receiving rituximab. Clin Rheumatol. 2014 Jun;33(6):799-805.

Knight A, Sundström Y, Börjesson O, Bruchfeld A, Malmström V, Gunnarsson I. Late-onset neutropenia after rituximab in ANCA-associated vasculitis. Scand J Rheumatol. 2016;45(5):404-407.

Parodis I, Söder F, Faustini F, et al. Rituximab-mediated late-onset neutropenia in systemic lupus erythematosus – distinct roles of BAFF and APRIL. Lupus. 2018;
60.

Md Yusof MY, Vital EM and Buch MH. B Cell Therapies, Approved and Emerging: a Review of Infectious Risk and Prevention During Use. Curr Rheumatol Rep. 2015; 17: 65.

Md Yusof MY, Vital EM, McElvenny DM, et al. Predicting Severe Infection and Effects of Hypogammaglobulinemia During Therapy With Rituximab in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2019;71(11):1812-1823.

Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Poetzl J, Shisha T, Kollins D. Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial. Rheumatology (Oxford). 2021 Jan 5;60(1):256-262. doi: 10.1093/rheumatology/keaa234. PMID: 32699904.

Sarilumab
Huizinga TWJ, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014;73(9):1626-34.

Genovese MC, van der Heijde D, Lin Y, St John G, Sheldon W, van Hoogstraten, Gomez-Reino JJ, Kivitz A, Maldonado-Cocco JA, Seriolo B, Stanislav M, Burmester GR. Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. RMD Open 2019; 5:e000887.

Emery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, van Hoogstraten H, Graham NMH, Liu N, Paccaly A, Wu R, Spindler A, Safety and Tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology 2019;58:849-858.

Fleischmann R, Genovese MC, Lin Y, et al. Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years’ follow-up. Rheumatology (Oxford). 2020;59(2):292-302.

Fleischmann R, Genovese MC, Maslova K, Leher H, Praestgaard A, Burmester GR. Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. Rheumatology (Oxford). 2021 Nov 3;60(11):4991-5001. doi: 10.1093/rheumatology/keab355. PMID: 33871596.

Genovese MC, Fleischmann R, Kivitz A, et al. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020;22(1):139.

Sekukinumab
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: 1137-46.

Baeten D, Sieper J, Braun J, et al. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. NEJM 2015; 373: 2534-48.

Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. The New England journal of medicine. 2015; 373: 1329-39.

Marzo-Ortega H, Sieper J, Kivitz A, Blanco R, Cohen M, Martin R, et al. Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study. Arthritis Care Res (Hoboken). 2017;69(7):1020-9.

Braun J, Baraliakos X, Deodhar A, Baeten D, Sieper J, Emery P, et al. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017;76(6):1070-7.

Van der Heijde D, Mease PJ, Landewé RBM, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Zhu X, Ligozio G, Readie A, Mpofu S, Pricop L. Sekukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology (Oxford) 2019 Oct 5, pii: kez420.

TNF-hämmare
Hastings R, Ding T, Butt S, et al. Neutropenia in patients receiving anti-tumor necrosis factor therapy. Arthritis Care Res (Hoboken). 2010 Jun;62(6):764-9.

Sokolove J, Strand V, Greenberg JD, et al. Risk of elevated liver enzymes associated with TNF inhibitor utilisation in patients with rheumatoid arthritis. Ann Rheum Dis. 2010 Sep;69(9):1612-7.

Bessissow T, Renard M, Hoffman I, et al. Review article: non-malignant haematological complications of anti-tumour necrosis factor alpha therapy. Aliment Pharmacol Ther. 2012 Aug;36(4):312-23.

Esposito M, Giunta A, Mazzotta A, et al. Efficacy and safety of subcutaneous anti-tumor necrosis factor-alpha agents, etanercept and adalimumab, in elderly patients affected by psoriasis and psoriatic arthritis: an observational long-term study. Dermatology. 2012;225(4):312-9.

Ghabril M, Bonkovsky HL, Kum C, et al. Liver injury from tumor necrosis factor-alpha antagonists: analysis of thirty-four cases. Clin Gastroenterol Hepatol. 2013 May;11(5):558-64 e3.

Jain A, Singh JA. Harms of TNF inhibitors in rheumatic diseases: a focused review of the literature. Immunotherapy. 2013 Mar;5(3):265-99.

Combe B, Dasgupta B, Louw I, et al. Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study. Ann Rheum Dis. 2014 Aug;73(8):1477-86.

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 Sep;73(9):1689-94.

Palazzi C, D’Angelo S, Leccese P, Padula A, Olivieri I. Safety of anti-tumor necrosis factor agents in psoriatic arthritis – an update. Expert Opin Drug Saf. 2014 Feb;13(2):191-6.

Rios Rodriguez V and Poddubnyy D. Golimumab for treatment of axial spondyloarthritis. Immunotherapy. 2016; 8: 107-15.

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 safety. 2015; 38: 869-88.

Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology (Oxford, England). 2017;56(10):1771-9.

Ruiz Garcia V, Burls A, Cabello JB, Vela Casasempere P, Bort-Marti S, Bernal JA. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults. The Cochrane database of systematic reviews. 2017;9:Cd007649.

Bae SC, Kim J, Choe JY, Park W, Lee SH, Park YB, et al. A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study. Ann Rheum Dis. 2017;76(1):65-71.

Tocilizumab
Genovese MC, Rubbert-Roth A, Smolen JS, et al. Longterm safety and efficacy of tocilizumab in patients with rheumatoid arthritis: a cumulative analysis of up to 4.6 years of exposure. J Rheumatol. 2013 Jun;40(6):768-80.

Strang AC, Bisoendial RJ, Kootte RS, et al. Pro-atherogenic lipid changes and decreased hepatic LDL receptor expression by tocilizumab in rheumatoid arthritis. Atherosclerosis. 2013 Jul;229(1):174-81.

Burmester GR, Rubbert-Roth A, Cantagrel A, et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis. 2014 Jan;73(1):69-74.

Iking-Konert C, von Hinuber U, Richter C, et al. ROUTINE-a prospective, multicentre, non-interventional, observational study to evaluate the safety and effectiveness of intravenous tocilizumab for the treatment of active rheumatoid arthritis in daily practice in Germany. Rheumatology (Oxford, England). 2016; 55: 624-35.

Moots RJ, Sebba A, Rigby W, Ostor A, Porter-Brown B, Donaldson F, et al. Effect of tocilizumab on neutrophils in adult patients with rheumatoid arthritis: pooled analysis of data from phase 3 and 4 clinical trials. Rheumatology (Oxford, England). 2017;56(4):541-9.

Emery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, van Hoogstraten H, Graham NMH, Liu N, Paccaly A, Wu R, Spindler A, Safety and Tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology 2019;58:849-858.

Ustekinumab
Kavanaugh A, Puig L, Gottlieb AB, et al. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016; 75: 1984-8.

Lopez-Ferrer A, Laiz A, Puig L. The safety of ustekinumab for the treatment of psoriatic arthritis. Expert Opin Drug Saf. 2017;16(6):733-42

 

Målinriktade syntetiska DMARDs (tsDMARDs):

Apremilast
Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Longterm (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis. J Rheumatol. 2015; 42: 479-88.

Souto A and Gomez-Reino JJ. Apremilast for the treatment of psoriatic arthritis. Expert review of clinical immunology. 2015; 11: 1281-90.
Mease PJ, Gladman DD, Gomez-Reino JJ, et al. Long-term (156-Week) Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Ar thritis: Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials [Poster]. Poster presented at: 2016 Annual Congress of the European League Against Rheumatism (EULAR); June 8-11, 2016

Mease PJ, Gladman DD, Gomez-Reino JJ, et al. Long-Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials [published online ahead of print, 2020 Jul 25]. ACR Open Rheumatol. 2020;2(8):459-470.

Avacopan
Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386. PMID: 33596356.

JAK-hämmare
Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, et al. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis & rheumatology (Hoboken, NJ). 2017;69(3):506-17.

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, et al. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017;76(7):1253-62.

Fleischmann R, Takeuchi T, Schiff M, et al. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020;72(8):1112-1121.

Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055. Erratum in: JAMA. 2020 Feb 4;323(5):480. PMID: 31334793; PMCID: PMC6652745.

Rubbert-Roth A, Enejosa J, Pangan AL, et al. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020;383(16):1511-1521.