Abstract
Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease known for causing pain, stiffness, and reduced mobility in the axial skeleton. Adalimumab, a tumor necrosis factor (TNF) inhibitor, has emerged as a promising therapeutic option for AS.
Methods: This systematic review involved a comprehensive search of randomized controlled trials related to AS treatment, conducted in major databases such as MEDLINE, Google Scholar, and PubMed. The search terms encompassed ankylosing spondylitis, adalimumab, methotrexate, other non-biologic DMARDs, glucocorticoids, NSAIDs, and analgesics. A total of 14 randomized controlled trials with 4,500 participants were included in the review.
Results: The review's results revealed that adalimumab demonstrated notable superiority when compared to a placebo. It effectively reduced disease activity, improved physical function, and lowered inflammatory markers such as C-reactive protein and erythrocyte sedimentation rate. Adalimumab demonstrated a favorable safety profile, with adverse events comparable to those observed with placebo.
Conclusion: Based on the results, adalimumab is deemed an effective treatment for AS, showcasing its potential as a first-line therapeutic option. Notably, no significant increase in adverse events was observed compared to placebo. However, the conclusion emphasizes the need for further studies with extended follow-up durations to ascertain the long-term efficacy and safety of adalimumab in AS management. This systematic review provides valuable insights supporting the use of adalimumab in the treatment of AS and underscores the importance of ongoing investigations into its long-term effects to optimize its clinical utilization in AS patients.
Keywords: Adalimumab, ankylosing spondylitis (AS), tumor necrosis factor (TNF), systematic review, efficacy, safety, randomized controlled trials.
Graphical Abstract
[1]
(a) Maghraoui EA, Mounach A. Efficacy and safety of adalimumab in ankylosing spondylitis. Open Access Rheumatol 2014; 6: 83-90.
[http://dx.doi.org/10.2147/OARRR.S44550] [PMID: 27790037];
(b) Rudwaleit M, Claudepierre P, Wordsworth P, et al. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol 2009; 36(4): 801-8.;
(c) Lambert RG, Salonen D, Rahman P, et al. Adalimumab significantly reduces both spinal and sacroiliac joint inflammation in patients with ankylosing spondylitis: A multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2007; 56(12): 4005.: 14.;
(d) Lebbink HR, Spoorenberg A, et al. The formation of autoantibodies and antibodies to TNF-alpha blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol 2010; 28(5): 661-8.
[http://dx.doi.org/10.2147/OARRR.S44550] [PMID: 27790037];
(b) Rudwaleit M, Claudepierre P, Wordsworth P, et al. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol 2009; 36(4): 801-8.;
(c) Lambert RG, Salonen D, Rahman P, et al. Adalimumab significantly reduces both spinal and sacroiliac joint inflammation in patients with ankylosing spondylitis: A multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2007; 56(12): 4005.: 14.;
(d) Lebbink HR, Spoorenberg A, et al. The formation of autoantibodies and antibodies to TNF-alpha blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol 2010; 28(5): 661-8.
[2]
Su J, Li M, He L, et al. Comparison of the efficacy and safety of adalimumab (Humira) and the adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis: A multicenter, randomized, double-blind, parallel, phase III clinical trial. BioDrugs 2020; 34(3): 381-93.
[http://dx.doi.org/10.1007/s40259-020-00408-z] [PMID: 32078145]
[http://dx.doi.org/10.1007/s40259-020-00408-z] [PMID: 32078145]
[3]
Uckun A, Sezer I. Ankylosing spondylitis and balance. Eurasian J Med 2017; 49(3): 207-10.
[http://dx.doi.org/10.5152/eurasianjmed.2017.17116] [PMID: 29123446]
[http://dx.doi.org/10.5152/eurasianjmed.2017.17116] [PMID: 29123446]
[4]
Cooksey R, Brophy S, Husain MJ, Irvine E, Davies H, Siebert S. The information needs of people living with ankylosing spondylitis: A questionnaire survey. BMC Musculoskelet Disord 2012; 13(1): 243.
[http://dx.doi.org/10.1186/1471-2474-13-243] [PMID: 23227937]
[http://dx.doi.org/10.1186/1471-2474-13-243] [PMID: 23227937]
[5]
Saglam Y, Ozturk I, Cakmak MF, Ozdemir M, Yazicioglu O. Total hip arthroplasty in patients with ankylosing spondylitis: Midterm radiologic and functional results. Acta Orthop Traumatol Turc 2016; 50(4): 443-7.
[http://dx.doi.org/10.1016/j.aott.2016.06.010] [PMID: 27492583]
[http://dx.doi.org/10.1016/j.aott.2016.06.010] [PMID: 27492583]
[6]
Ward MM. Complications of total hip arthroplasty in patients with ankylosing spondylitis. Arthritis Care Res 2019; 71(8): 1101-8.
[http://dx.doi.org/10.1002/acr.23582] [PMID: 29669197]
[http://dx.doi.org/10.1002/acr.23582] [PMID: 29669197]
[7]
Lin D, Charalambous A, Hanna SA. Bilateral total hip arthroplasty in ankylosing spondylitis: A systematic review. EFORT Open Rev 2019; 4(7): 476-81.
[http://dx.doi.org/10.1302/2058-5241.4.180047] [PMID: 31423331]
[http://dx.doi.org/10.1302/2058-5241.4.180047] [PMID: 31423331]
[8]
Webers C, Essers I, Ramiro S, et al. Gender-attributable differences in outcome of ankylosing spondylitis: long-term results from the Outcome in Ankylosing Spondylitis International Study. Rheumatology 2015; 55(3): 419-28.
[http://dx.doi.org/10.1093/rheumatology/kev340] [PMID: 26385369]
[http://dx.doi.org/10.1093/rheumatology/kev340] [PMID: 26385369]
[9]
Guan M, Wang J, Zhao L, Xiao J, Li Z, Shi Z. Management of hip involvement in ankylosing spondylitis. Clin Rheumatol 2013; 32(8): 1115-20.
[http://dx.doi.org/10.1007/s10067-013-2278-3] [PMID: 23624589]
[http://dx.doi.org/10.1007/s10067-013-2278-3] [PMID: 23624589]
[10]
Joshi A, Ilchmann T, Markovic L. Socket wear in bilateral simultaneous total hip arthroplasty. J Arthroplasty 2001; 16(1): 117-20.
[http://dx.doi.org/10.1054/arth.2001.19160] [PMID: 11172281]
[http://dx.doi.org/10.1054/arth.2001.19160] [PMID: 11172281]
[11]
Uluçay C, Ozler T, Güven M, Akman B, Kocadal AO, Altıntaş F. Etiology of coxarthrosis in patients with total hip replacement. Acta Orthop Traumatol Turc 2013; 47(5): 330-3.
[http://dx.doi.org/10.3944/AOTT.2013.3103] [PMID: 24164942]
[http://dx.doi.org/10.3944/AOTT.2013.3103] [PMID: 24164942]
[12]
Yacoub IY, Amine B, Laatiris A, Hassouni HN. Gender and disease features in Moroccan patients with ankylosing spondylitis. Clin Rheumatol 2012; 31(2): 293-7.
[http://dx.doi.org/10.1007/s10067-011-1819-x] [PMID: 21796348]
[http://dx.doi.org/10.1007/s10067-011-1819-x] [PMID: 21796348]
[13]
He C, He X, Tong W, et al. The effect of total hip replacement on employment in patients with ankylosing spondylitis. Clin Rheumatol 2016; 35(12): 2975-81.
[http://dx.doi.org/10.1007/s10067-016-3431-6] [PMID: 27734230]
[http://dx.doi.org/10.1007/s10067-016-3431-6] [PMID: 27734230]
[14]
Nystad TW, Furnes O, Havelin LI. Hip replacement surgery in patients with ankylosing spondylitis. Ann Rheum Dis 2014; 73: 1194-7.
[http://dx.doi.org/10.1136/annrheumdis-2013-203963] [PMID: 24285490]
[http://dx.doi.org/10.1136/annrheumdis-2013-203963] [PMID: 24285490]
[15]
Feng D, Zhang K, Zhang Y, et al. Bilaterally primary cementless total hip arthroplasty for severe hip ankylosis with ankylosing spondylitis. Orthop Surg 2016; 8(3): 352-9.
[http://dx.doi.org/10.1111/os.12254] [PMID: 27627719]
[http://dx.doi.org/10.1111/os.12254] [PMID: 27627719]
[16]
Zhang L, Yang D, Yin X, Zhou Y. Risk factors for poor hip flexion after total hip arthroplasty for the treatment of ankylosing spondylitis a multivariate analysis. Clin Rheumatol 2014; 33(9): 1295-301.
[http://dx.doi.org/10.1007/s10067-014-2575-5] [PMID: 24651916]
[http://dx.doi.org/10.1007/s10067-014-2575-5] [PMID: 24651916]
[17]
Gautam D, Malhotra R. Total hip arthroplasty in ankylosing spondylitis with extension contracture of hips. J Arthroplasty 2019; 34(1): 71-6.
[http://dx.doi.org/10.1016/j.arth.2018.08.025] [PMID: 30342954]
[http://dx.doi.org/10.1016/j.arth.2018.08.025] [PMID: 30342954]
[18]
Tikhilov RM, Nikolaev NS, Shubnyakov II, et al. Difficulties of total hip replacement in patients with ankylosing spondylitis (case report). Traumatol Orthop Russia 2016; 22(2): 70-9.
[http://dx.doi.org/10.21823/2311-2905-2016-0-2-70-79]
[http://dx.doi.org/10.21823/2311-2905-2016-0-2-70-79]
[19]
Braun J. Axial spondyloarthritis including ankylosing spondylitis. Rheumatology 2018; 57(S6): vi1-3.
[http://dx.doi.org/10.1093/rheumatology/key079] [PMID: 30445482]
[http://dx.doi.org/10.1093/rheumatology/key079] [PMID: 30445482]
[20]
Cho H, Kim T, Kim TH, Lee S, Lee KH. Spinal mobility, vertebral squaring, pulmonary function, pain, fatigue, and quality of life in patients with ankylosing spondylitis. Ann Rehabil Med 2013; 37(5): 675-82.
[http://dx.doi.org/10.5535/arm.2013.37.5.675] [PMID: 24236255]
[http://dx.doi.org/10.5535/arm.2013.37.5.675] [PMID: 24236255]
[21]
Chen B, Li J, He C, et al. Role of HLA-B27 in the pathogenesis of ankylosing spondylitis. Mol Med Rep 2017; 15(4): 1943-51.
[http://dx.doi.org/10.3892/mmr.2017.6248] [PMID: 28259985]
[http://dx.doi.org/10.3892/mmr.2017.6248] [PMID: 28259985]
[22]
Lin H, Gong YZ. Association of HLA-B27 with ankylosing spondylitis and clinical features of the HLA-B27-associated ankylosing spondylitis: A meta-analysis. Rheumatol Int 2017; 37(8): 1267-80.
[http://dx.doi.org/10.1007/s00296-017-3741-2] [PMID: 28526894]
[http://dx.doi.org/10.1007/s00296-017-3741-2] [PMID: 28526894]
[23]
Arévalo M, Masmitjà GJ, Moreno M, et al. Influence of HLA-B27 on the ankylosing spondylitis phenotype: Results from the REGISPONSER database. Arthritis Res Ther 2018; 20(1): 221.
[http://dx.doi.org/10.1186/s13075-018-1724-7] [PMID: 30285828]
[http://dx.doi.org/10.1186/s13075-018-1724-7] [PMID: 30285828]
[24]
Akassou A, Bakri Y. Does HLA-B27 status influence ankylosing spondylitis phenotype? Clin Med Insights Arthritis Musculoskelet Disord 2018; 11: 1179544117751627.
[http://dx.doi.org/10.1177/1179544117751627] [PMID: 29343996]
[http://dx.doi.org/10.1177/1179544117751627] [PMID: 29343996]
[25]
Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet 2017; 390(10089): 73-84.
[http://dx.doi.org/10.1016/S0140-6736(16)31591-4] [PMID: 28110981]
[http://dx.doi.org/10.1016/S0140-6736(16)31591-4] [PMID: 28110981]
[26]
Taurog JD, Chhabra A, Colbert RA. Ankylosing spondylitis and axial spondyloarthritis. N Engl J Med 2016; 374(26): 2563-74.
[http://dx.doi.org/10.1056/NEJMra1406182] [PMID: 27355535]
[http://dx.doi.org/10.1056/NEJMra1406182] [PMID: 27355535]
[27]
Fan M, Liu J, Zhao B, Wu X, Li X, Gu J. Indirect comparison of NSAIDs for ankylosing spondylitis: Network meta-analysis of randomized, double-blinded, controlled trials. Exp Ther Med 2020; 19(4): 3031-41.
[http://dx.doi.org/10.3892/etm.2020.8564] [PMID: 32256790]
[http://dx.doi.org/10.3892/etm.2020.8564] [PMID: 32256790]
[28]
Karmacharya P, Shahukhal R, Crowson CS, et al. Effects of therapies on cardiovascular events in ankylosing spondylitis: A systematic review and meta-analysis. Rheumatol Ther 2020; 7(4): 993-1009.
[http://dx.doi.org/10.1007/s40744-020-00248-x] [PMID: 33170493]
[http://dx.doi.org/10.1007/s40744-020-00248-x] [PMID: 33170493]
[29]
George MD, Baker JF, Ogdie A. Comparative persistence of methotrexate and tumor necrosis factor inhibitors in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J Rheumatol 2020; 47(6): 826-34.
[http://dx.doi.org/10.3899/jrheum.190299] [PMID: 31474599]
[http://dx.doi.org/10.3899/jrheum.190299] [PMID: 31474599]
[30]
Lindström U, Olofsson T, Wedrén S, Qirjazo I, Askling J. Biological treatment of ankylosing spondylitis: A nationwide study of treatment trajectories on a patient level in clinical practice. Arthritis Res Ther 2019; 21(1): 128.
[http://dx.doi.org/10.1186/s13075-019-1908-9] [PMID: 31138285]
[http://dx.doi.org/10.1186/s13075-019-1908-9] [PMID: 31138285]
[31]
Armuzzi A, Lionetti P, Blandizzi C, et al. anti-TNF agents as therapeutic choice in immune-mediated inflammatory diseases: focus on adalimumab. Int J Immunopathol Pharmacol 2014; 27(S1): 11-32.
[http://dx.doi.org/10.1177/03946320140270S102] [PMID: 24774504]
[http://dx.doi.org/10.1177/03946320140270S102] [PMID: 24774504]
[32]
Wroński J, Fiedor P. The safety profile of tumor necrosis factor inhibitors in ankylosing spondylitis: Are TNF inhibitors safer than we thought? J Clin Pharmacol 2019; 59(4): 445-62.
[http://dx.doi.org/10.1002/jcph.1348] [PMID: 30476367]
[http://dx.doi.org/10.1002/jcph.1348] [PMID: 30476367]
[33]
Heinonen AV, Aaltonen KJ, Joensuu JT, et al. Effectiveness and drug survival of TNF inhibitors in the treatment of ankylosing spondylitis: A prospective cohort study. J Rheumatol 2015; 42(12): 2339-46.
[http://dx.doi.org/10.3899/jrheum.150389] [PMID: 26472421]
[http://dx.doi.org/10.3899/jrheum.150389] [PMID: 26472421]
[34]
Machado MAÁ, Barbosa MM, Almeida AM, et al. Treatment of ankylosing spondylitis with TNF blockers: A meta-analysis. Rheumatol Int 2013; 33(9): 2199-213.
[http://dx.doi.org/10.1007/s00296-013-2772-6] [PMID: 23686218]
[http://dx.doi.org/10.1007/s00296-013-2772-6] [PMID: 23686218]
[35]
Haroon N, Inman RD, Learch TJ, et al. The impact of tumor necrosis factor α inhibitors on radiographic progression in ankylosing spondylitis. Arthritis Rheum 2013; 65(10): 2645-54.
[http://dx.doi.org/10.1002/art.38070] [PMID: 23818109]
[http://dx.doi.org/10.1002/art.38070] [PMID: 23818109]
[36]
Hou L, Jiang G, Chen Y, et al. The comparative safety of TNF inhibitors in ankylosing spondylitis—a meta-analysis update of 14 randomized controlled trials. Clin Rev Allergy Immunol 2018; 54(2): 234-43.
[http://dx.doi.org/10.1007/s12016-017-8623-6] [PMID: 28717941]
[http://dx.doi.org/10.1007/s12016-017-8623-6] [PMID: 28717941]
[37]
Burmester GR, Panaccione R, Gordon KB, McIlraith MJ, Lacerda APM. Adalimumab: Long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis 2013; 72(4): 517-24.
[http://dx.doi.org/10.1136/annrheumdis-2011-201244] [PMID: 22562972]
[http://dx.doi.org/10.1136/annrheumdis-2011-201244] [PMID: 22562972]
[38]
Murdaca GG, Spanà F, Puppo F. Long-term treatment of rheumatoid arthritis with adalimumab. Open Access Rheumatol 2013; 43: 43.
[http://dx.doi.org/10.2147/OARRR.S32582]
[http://dx.doi.org/10.2147/OARRR.S32582]
[39]
Horneff G, Seyger MMB, Arikan D, et al. Safety of adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, and crohn’s disease. J Pediatr 2018; 201: 166-175.e3.
[http://dx.doi.org/10.1016/j.jpeds.2018.05.042] [PMID: 30054164]
[http://dx.doi.org/10.1016/j.jpeds.2018.05.042] [PMID: 30054164]
[40]
D’Angelo S, Cantini F, Ramonda R, et al. Effectiveness of adalimumab for the treatment of psoriatic arthritis: An italian real-life retrospective study. Front Pharmacol 2019; 10: 1497.
[http://dx.doi.org/10.3389/fphar.2019.01497] [PMID: 31920675]
[http://dx.doi.org/10.3389/fphar.2019.01497] [PMID: 31920675]
[41]
Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet 2019; 394(10198): 576-86.
[http://dx.doi.org/10.1016/S0140-6736(19)30952-3] [PMID: 31280967]
[http://dx.doi.org/10.1016/S0140-6736(19)30952-3] [PMID: 31280967]
[42]
Abbass M, Cepek J, Parker CE, et al. Adalimumab for induction of remission in Crohn’s disease. Cochrane Libr 2019; 2019(11): CD012878.
[http://dx.doi.org/10.1002/14651858.CD012878.pub2] [PMID: 31742665]
[http://dx.doi.org/10.1002/14651858.CD012878.pub2] [PMID: 31742665]
[43]
Ternant D, Ducourau E, Fuzibet P, et al. Pharmacokinetics and concentration–effect relationship of adalimumab in rheumatoid arthritis. Br J Clin Pharmacol 2015; 79(2): 286-97.
[http://dx.doi.org/10.1111/bcp.12509] [PMID: 25223394]
[http://dx.doi.org/10.1111/bcp.12509] [PMID: 25223394]
[44]
Kingsbury DJ, Bader-Meunier B, Patel G, Arora V, Kalabic J, Kupper H. Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years. Clin Rheumatol 2014; 33(10): 1433-41.
[http://dx.doi.org/10.1007/s10067-014-2498-1] [PMID: 24487484]
[http://dx.doi.org/10.1007/s10067-014-2498-1] [PMID: 24487484]
[45]
Lemos LLP, de Costa OJ, 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(10): 1345-60.
[http://dx.doi.org/10.1007/s00296-014-3006-2] [PMID: 24728068]
[http://dx.doi.org/10.1007/s00296-014-3006-2] [PMID: 24728068]
[46]
Vogelzang EH, Pouw MF, Nurmohamed M, et al. Adalimumab trough concentrations in patients with rheumatoid arthritis and psoriatic arthritis treated with concomitant disease-modifying antirheumatic drugs. Ann Rheum Dis 2015; 74(2): 474-5.
[http://dx.doi.org/10.1136/annrheumdis-2014-206588] [PMID: 25433018]
[http://dx.doi.org/10.1136/annrheumdis-2014-206588] [PMID: 25433018]
[47]
Sator P. Safety and tolerability of adalimumab for the treatment of psoriasis: A review summarizing 15 years of real-life experience. Ther Adv Chronic Dis 2018; 9(8): 147-58.
[http://dx.doi.org/10.1177/2040622318772705] [PMID: 30065812]
[http://dx.doi.org/10.1177/2040622318772705] [PMID: 30065812]
[48]
Burness CB, McKeage K. Adalimumab: A review in chronic plaque psoriasis. Drugs 2015; 75(18): 2119-30.
[http://dx.doi.org/10.1007/s40265-015-0503-x] [PMID: 26586242]
[http://dx.doi.org/10.1007/s40265-015-0503-x] [PMID: 26586242]
[49]
Colombel JF, Rutgeerts PJ, Sandborn WJ, et al. Adalimumab induces deep remission in patients with Crohn’s disease. Clin Gastroenterol Hepatol 2014; 12(3): 414-422.e5.
[http://dx.doi.org/10.1016/j.cgh.2013.06.019] [PMID: 23856361]
[http://dx.doi.org/10.1016/j.cgh.2013.06.019] [PMID: 23856361]
[50]
Adegbola SO, Sahnan K, Warusavitarne J, Hart A, Tozer P. Anti-TNF therapy in crohn’s disease. Int J Mol Sci 2018; 19(8): 2244.
[http://dx.doi.org/10.3390/ijms19082244] [PMID: 30065229]
[http://dx.doi.org/10.3390/ijms19082244] [PMID: 30065229]
[51]
Bouhnik Y, Carbonnel F, Laharie D, et al. Efficacy of adalimumab in patients with Crohn’s disease and symptomatic small bowel stricture: A multicentre, prospective, observational cohort (CREOLE) study. Gut 2018; 67(1): 53-60.
[http://dx.doi.org/10.1136/gutjnl-2016-312581] [PMID: 28119352]
[http://dx.doi.org/10.1136/gutjnl-2016-312581] [PMID: 28119352]
[52]
Smolen JS, Emery P, Fleischmann R, et al. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: The randomised controlled OPTIMA trial. Lancet 2014; 383(9914): 321-32.
[http://dx.doi.org/10.1016/S0140-6736(13)61751-1] [PMID: 24168956]
[http://dx.doi.org/10.1016/S0140-6736(13)61751-1] [PMID: 24168956]
[53]
Jang D, Lee AH, Shin HY, et al. The role of tumor necrosis factor alpha (TNF-α) in autoimmune disease and current TNF-α inhibitors in therapeutics. Int J Mol Sci 2021; 22(5): 2719.
[http://dx.doi.org/10.3390/ijms22052719] [PMID: 33800290]
[http://dx.doi.org/10.3390/ijms22052719] [PMID: 33800290]
[54]
Haranaka M, Tanaka T, Kim S, et al. Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: randomized study in healthy Japanese adults. Immunotherapy 2023; 15(3): 149-61.
[http://dx.doi.org/10.2217/imt-2022-0181] [PMID: 36748363]
[http://dx.doi.org/10.2217/imt-2022-0181] [PMID: 36748363]
[55]
Huang F, Gu J, Zhu P, et al. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial. Ann Rheum Dis 2014; 73(3): 587-94.
[http://dx.doi.org/10.1136/annrheumdis-2012-202533] [PMID: 23475983]
[http://dx.doi.org/10.1136/annrheumdis-2012-202533] [PMID: 23475983]
[56]
Terslev L, Naredo E, Iagnocco A, et al. Defining enthesitis in spondyloarthritis by ultrasound: Results of a Delphi process and of a reliability reading exercise. Arthritis Care Res 2014; 66(5): 741-8.
[http://dx.doi.org/10.1002/acr.22191] [PMID: 24151222]
[http://dx.doi.org/10.1002/acr.22191] [PMID: 24151222]
[57]
Truong S, McEwan T, Bird P, et al. Australian consensus statements for the assessment and management of non-radiographic axial spondyloarthritis. Rheumatol Ther 2022; 9(1): 1-24.
[http://dx.doi.org/10.1007/s40744-021-00416-7] [PMID: 34962620]
[http://dx.doi.org/10.1007/s40744-021-00416-7] [PMID: 34962620]
[58]
Robinson PC, Sengupta R, Siebert S. Non-radiographic axial spondyloarthritis (nr-axSpA): Advances in classification, imaging and therapy. Rheumatol Ther 2019; 6(2): 165-77.
[http://dx.doi.org/10.1007/s40744-019-0146-6] [PMID: 30788779]
[http://dx.doi.org/10.1007/s40744-019-0146-6] [PMID: 30788779]
[59]
van der Linden S, Akkoc N, Brown MA, Robinson PC, Khan MA. The ASAS criteria for axial spondyloarthritis: Strengths, weaknesses, and proposals for a way forward. Curr Rheumatol Rep 2015; 17(9): 62.
[http://dx.doi.org/10.1007/s11926-015-0535-y] [PMID: 26286179]
[http://dx.doi.org/10.1007/s11926-015-0535-y] [PMID: 26286179]
[60]
Sieper J, van der Heijde D, Dougados M, et al. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: Results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis 2013; 72(6): 815-22.
[http://dx.doi.org/10.1136/annrheumdis-2012-201766] [PMID: 22772328]
[http://dx.doi.org/10.1136/annrheumdis-2012-201766] [PMID: 22772328]
[61]
van der Heijde D, Breban M, Halter D, et al. Maintenance of improvement in spinal mobility, physical function and quality of life in patients with ankylosing spondylitis after 5 years in a clinical trial of adalimumab. Rheumatology 2015; 54(7): 1210-9.
[http://dx.doi.org/10.1093/rheumatology/keu438] [PMID: 25541333]
[http://dx.doi.org/10.1093/rheumatology/keu438] [PMID: 25541333]
[62]
Ward MM, Deodhar A, Akl EA, et al. American college of rheumatology/spondylitis association of America/spondyloarthritis research and treatment network 2015 recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol 2016; 68(2): 282-98.
[http://dx.doi.org/10.1002/art.39298] [PMID: 26401991]
[http://dx.doi.org/10.1002/art.39298] [PMID: 26401991]
[63]
Su J, Li M, He L, et al. Changes in efficacy indicators for adalimumab biosimilar candidate (HS016) for the treatment of active ankylosing spondylitis at various time points. Front Pharmacol 2020; 11: 606497.
[http://dx.doi.org/10.3389/fphar.2020.606497] [PMID: 33364967]
[http://dx.doi.org/10.3389/fphar.2020.606497] [PMID: 33364967]
[64]
Pelechas E, Voulgari PV, Drosos AA. ABP 501 for the treatment of rheumatoid arthritis. Expert Opin Biol Ther 2018; 18(3): 317-22.
[http://dx.doi.org/10.1080/14712598.2018.1430760] [PMID: 29350566]
[http://dx.doi.org/10.1080/14712598.2018.1430760] [PMID: 29350566]
[65]
Xu H, Li Z, Wu J, et al. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: A randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol 2019; 1(1): e35-43.
[http://dx.doi.org/10.1016/S2665-9913(19)30013-X] [PMID: 38229357]
[http://dx.doi.org/10.1016/S2665-9913(19)30013-X] [PMID: 38229357]
[66]
Jones A, Ciurtin C, Ismajli M, Leandro M, Sengupta R, Machado PM. Biologics for treating axial spondyloarthritis. Expert Opin Biol Ther 2018; 18(6): 641-52.
[http://dx.doi.org/10.1080/14712598.2018.1468884] [PMID: 29681195]
[http://dx.doi.org/10.1080/14712598.2018.1468884] [PMID: 29681195]
[67]
Dörner T, Kay J. Biosimilars in rheumatology: Current perspectives and lessons learnt. Nat Rev Rheumatol 2015; 11(12): 713-24.
[http://dx.doi.org/10.1038/nrrheum.2015.110] [PMID: 26282080]
[http://dx.doi.org/10.1038/nrrheum.2015.110] [PMID: 26282080]
[68]
Lyman GH, Zon R, Harvey RD, Schilsky RL. Rationale, opportunities, and reality of biosimilar medications. N Engl J Med 2018; 378(21): 2036-44.
[http://dx.doi.org/10.1056/NEJMhle1800125] [PMID: 29791832]
[http://dx.doi.org/10.1056/NEJMhle1800125] [PMID: 29791832]
[69]
Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: Initial experience and future potential. Rand Health Q 2017; 7(4): 3.
[http://dx.doi.org/10.7249/PE264]
[http://dx.doi.org/10.7249/PE264]
[70]
Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): A 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017; 389(10086): 2304-16.
[http://dx.doi.org/10.1016/S0140-6736(17)30068-5] [PMID: 28502609]
[http://dx.doi.org/10.1016/S0140-6736(17)30068-5] [PMID: 28502609]
[71]
Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2017; 76(2): 346-54.
[http://dx.doi.org/10.1136/annrheumdis-2015-208783] [PMID: 27117698]
[http://dx.doi.org/10.1136/annrheumdis-2015-208783] [PMID: 27117698]
[72]
Evripidis K, Eleftherios P, Paraskevi VV, Alexandros DA. Maintained clinical remission in ankylosing spondylitis patients switched from reference infliximab to its biosimilar: An 18-month comparative open-label study. J Clin Med 2019; 8(7): 956.
[http://dx.doi.org/10.3390/jcm8070956] [PMID: 31269678]
[http://dx.doi.org/10.3390/jcm8070956] [PMID: 31269678]
[73]
Su J, Li M, He L, et al. Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: Sub-analysis of a phase 3 study. Clin Rheumatol 2022; 41(3): 731-9.
[http://dx.doi.org/10.1007/s10067-021-05943-w] [PMID: 34709497]
[http://dx.doi.org/10.1007/s10067-021-05943-w] [PMID: 34709497]
[74]
Maksymowych WP, Strand V, Nash P, et al. Comparative effectiveness of secukinumab and adalimumab in ankylosing spondylitis as assessed by matching-adjusted indirect comparison. Eur J Rheumatol 2018; 5(4): 216-23.
[http://dx.doi.org/10.5152/eurjrheum.2018.18162] [PMID: 30388073]
[http://dx.doi.org/10.5152/eurjrheum.2018.18162] [PMID: 30388073]
[75]
Persaud T, Morgan R, Thant HL, DeAsis FJ, Ferre F, Diaz J. Adalimumab mitigates lumbar radiculopathy in a case of ankylosing spondylitis. Am J Case Rep 2022; 23: e936600.
[http://dx.doi.org/10.12659/AJCR.936600] [PMID: 35776690]
[http://dx.doi.org/10.12659/AJCR.936600] [PMID: 35776690]
[76]
Akkoç N, Yarkan H, Kenar G, Khan MA. Ankylosing spondylitis: HLA-B*27-positive versus HLA-B*27-negative disease. Curr Rheumatol Rep 2017; 19(5): 26.
[http://dx.doi.org/10.1007/s11926-017-0654-8] [PMID: 28386763]
[http://dx.doi.org/10.1007/s11926-017-0654-8] [PMID: 28386763]
[77]
de Koning A, Schoones JW, van der Heijde D, van Gaalen FA. Pathophysiology of axial spondyloarthritis: Consensus and controversies. Eur J Clin Invest 2018; 48(5): e12913.
[http://dx.doi.org/10.1111/eci.12913] [PMID: 29460306]
[http://dx.doi.org/10.1111/eci.12913] [PMID: 29460306]
[78]
Blair HA. Secukinumab: A review in ankylosing spondylitis. Drugs 2019; 79(4): 433-43.
[http://dx.doi.org/10.1007/s40265-019-01075-3] [PMID: 30793255]
[http://dx.doi.org/10.1007/s40265-019-01075-3] [PMID: 30793255]
[79]
Zhu W, He X, Cheng K, et al. Ankylosing spondylitis: Etiology, pathogenesis, and treatments. Bone Res 2019; 7(1): 22.
[http://dx.doi.org/10.1038/s41413-019-0057-8] [PMID: 31666997]
[http://dx.doi.org/10.1038/s41413-019-0057-8] [PMID: 31666997]
[80]
Tu L, Xie Y, Liao Z, et al. Cost of illness, quality of life, and work outcomes in active ankylosing spondylitis patients treated with adalimumab in China. Front Public Health 2020; 8: 602334.
[http://dx.doi.org/10.3389/fpubh.2020.602334] [PMID: 33330342]
[http://dx.doi.org/10.3389/fpubh.2020.602334] [PMID: 33330342]
[81]
Machado MAÁ, Ferré F, Moura CS, et al. Costs of drug therapy in patients with ankylosing spondylitis in Brazil. Rheumatol Ther 2016; 3(2): 353-61.
[http://dx.doi.org/10.1007/s40744-016-0036-0] [PMID: 27747578]
[http://dx.doi.org/10.1007/s40744-016-0036-0] [PMID: 27747578]
[82]
Cooksey R, Husain MJ, Brophy S, et al. The cost of ankylosing spondylitis in the UK using linked routine and patient-reported survey data. PLoS One 2015; 10(7): e0126105.
[http://dx.doi.org/10.1371/journal.pone.0126105] [PMID: 26185984]
[http://dx.doi.org/10.1371/journal.pone.0126105] [PMID: 26185984]
[83]
Opris-Belinski D, Erdes SF, Grazio S, et al. Impact of adalimumab on clinical outcomes, healthcare resource utilization, and sick leave in patients with ankylosing spondylitis: An observational study from five Central and Eastern European countries. Drugs Context 2018; 7: 1-8.
[http://dx.doi.org/10.7573/dic.212556] [PMID: 30483351]
[http://dx.doi.org/10.7573/dic.212556] [PMID: 30483351]
[84]
Schofield D, Shrestha R, Cunich M. The economic impacts of using adalimumab (Humira ® ) for reducing pain in people with ankylosing spondylitis: A microsimulation study for Australia. Int J Rheum Dis 2018; 21(5): 1106-13.
[http://dx.doi.org/10.1111/1756-185X.13277] [PMID: 29611342]
[http://dx.doi.org/10.1111/1756-185X.13277] [PMID: 29611342]
[85]
Szántó S, Poór G, Opris D, et al. Improved clinical, functional and work outcomes in spondyloarthritides during real-life adalimumab treatment in central–eastern Europe. J Comp Eff Res 2016; 5(5): 475-85.
[http://dx.doi.org/10.2217/cer-2016-0020] [PMID: 27417564]
[http://dx.doi.org/10.2217/cer-2016-0020] [PMID: 27417564]
[86]
Boonen A, Boone C, Albert A, Mielants H. Understanding limitations in at-work productivity in patients with active ankylosing spondylitis: The role of work-related contextual factors. J Rheumatol 2015; 42(1): 93-100.
[http://dx.doi.org/10.3899/jrheum.131287] [PMID: 25362661]
[http://dx.doi.org/10.3899/jrheum.131287] [PMID: 25362661]
[87]
Ortiz CJD, Ramiro S, Landewé R, et al. Work outcome in patients with ankylosing spondylitis: Results from a 12-year followup of an international study. Arthritis Care Res 2016; 68(4): 544-52.
[http://dx.doi.org/10.1002/acr.22730] [PMID: 26414460]
[http://dx.doi.org/10.1002/acr.22730] [PMID: 26414460]
[88]
Sağ S, Nas K, Sağ MS, Tekeoğlu İ, Kamanlı A. Relationship of work disability between the disease activity, depression and quality of life in patients with ankylosing spondylitis. J Back Musculoskeletal Rehabil 2018; 31(3): 499-505.
[http://dx.doi.org/10.3233/BMR-169657] [PMID: 29504521]
[http://dx.doi.org/10.3233/BMR-169657] [PMID: 29504521]
[89]
Goh Y, Kwan YH, Leung YY, Fong W, Cheung PP. A cross-sectional study on factors associated with poor work outcomes in patients with axial spondyloarthritis in Singapore. Int J Rheum Dis 2019; 22(11): 2001-8.
[http://dx.doi.org/10.1111/1756-185X.13696] [PMID: 31576680]
[http://dx.doi.org/10.1111/1756-185X.13696] [PMID: 31576680]
[90]
Espahbodi S, Bassett P, Cavill C, Freeth M, Hole J, Sengupta R. Fatigue contributes to work productivity impairment in patients with axial spondyloarthritis: a cross-sectional UK study. Clin Exp Rheumatol 2017; 35(4): 571-8.
[PMID: 28240589]
[PMID: 28240589]
[91]
Wang H, Zuo D, Sun M, Hua Y, Cai Z. Randomized, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: A meta-analysis. Int J Rheum Dis 2014; 17(2): 142-8.
[http://dx.doi.org/10.1111/1756-185X.12245] [PMID: 24506823]
[http://dx.doi.org/10.1111/1756-185X.12245] [PMID: 24506823]
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