Tunisian Good Clinical Practice Recommendations for the Management of Spondyloarthritis by Biological Agents
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Abstract
Aim: To elaborate Tunisian recommendations for the therapeutic management in current practice of patients with spondyloarthritis who are candidates for treatment with a biological agent.
Methods : Following the standardized procedures of the INEAS (Instance Nationale de l'Evaluation et de l'Accréditation en Santé) and in collaboration with the LITAR (Tunisian League against Rheumatism), a systematic review of the literature, carried out by 6 rheumatologists, based on the questions individualized by the working group (15 expert rheumatologists), served as the basis for the working meetings, with determination of the strength of the recommendations and the degree of agreement of the experts. The recommendations were validated by an independent reading group comprising 19 experts from various related specialties.
Results: Ten recommendations for good practice were drawn up. The first 2 recommendations concern the pre-therapeutic assessment and the updating of immunisation status prior to the initiation of biotherapy. Recommendations 3 to 8 deal with the use of biologics, including the new classes, in their indications (active disease despite conventional treatment, and for non-radiographic axial forms, presence of objective signs of inflammation) and follow-up, and their management in the event of failure or in remission. Recommendations 9 and 10 concern management in the event of pregnancy or neoplasia. The strength of the recommendations ranged from 8 to 9, with a degree of agreement of between 72% and 100%.
Conclusion:This work, supported by LITAR and accredited by INEAS, takes into account the data in the literature and the predominant clinical presentation....( abstract truncated at 250 words).
Keywords:
Spondyloarthritis, Treatment, Recommendations##plugins.themes.academic_pro.article.details##
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
- - MM Ward, A Deodhar, LS Gensler, M Dubreuil, D Yu, MA Khan, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/SpondyloarthritisResearch and Treatment Network Recommendations for the Treatment of AnkylosingSpondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-13.
- - L Gossec, A Kerschbaumer, RJO Ferreira, D Aletaha, X Baraliakos, H Bertheussen, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024;83(6):706-19.
- - D. Wendling, C. Lukas, C. Prati, P Claudepierre, L Gossec, P Goupille, et al. 2018 update of French Society for Rheumatology (SFR) recommendations about the everyday management of patients withspondyloarthritis. Joint Bone Spine. 2018;85(3):275-84.
- - Hamdi W, Zrour S, Maatallah K, Younès M, Fazaa A, Miladi S et al. Les recommandations de bonne pratique pour le diagnostic et l’évaluation des Spondyloarthrites. Tunis Med. 2025;103(1):22-31. DOI: 10.62438/tunismed.v103i1.5565
- - Laatar A, Miladi S, Fazaa A, Tekaya R, Ben Tekaya A, Manaa M et al. Les recommandations de bonne pratique pour la prise en charge thérapeutique des Spondyloarthrites (Traitement biologique exclu). Tunis Med. 2025;103(1):32-43. DOI: 10.62438/tunismed. v103i1.5563
- - Baccouche K, Mahmoud I, Manaa M, Gharsallah I, Testouri N, Maatallah K et al. Recommandations Tunisiennes de bonnes pratiques pour la prise en charge des Spondylarthrites: Méthodologie. Tunis Med. 2025;103(1):18-21. DOI: 10.62438/tunismed.v103i1.5550
- - Kisacik B, Pamuk ON, Onat AM, Erer SB, Hatemi G, Ozguler Y, et al. Characteristics Predicting Tuberculosis Risk under Tumor Necrosis Factor-α Inhibitors: Report from a Large Multicenter Cohor twith High Background Prevalence. J Rheumatol. 2016;43(3):524-9.
- - Slouma M, Mahmoud I, Saidane O, Bouden S, Abdelmoula L. Latent tuberculosis infection screening prior to biological treatment in Tunisian patients. Therapie. 2017;72(5):573-8.
- - Vassilopoulos D, Tsikrika S, Hatzara C, Podia V, Kandili A, Stamoulis N, et al. Comparison of two gamma interferon release assays and tuberculin skin testing for tuberculosis screening in a cohort of patients withrheumaticdiseasesstarting anti-tumornecrosis factor therapy. Clin Vaccine Immunol. 2011;18(12):2102-8.
- - Gogus F, Günendi Z, Karakus R, Erdogan Z, Hizel K, Atalay F. Comparison of tuberculin skin test and QuantiFERON-TB gold in tube test in patients with chronic inflammatory diseases living in a tuberculosisendemic population. Clin Exp Med. 2010;10(3):173-7.
- - Nobre CA, Callado MR, Lima JR, Gomes KW, Martiniano GV, Vieira WP. Tuberculosis infection in rheumatic patients with infliximab therapy: experience with 157 patients. Rheumatol Int. 2012;32(9):2769-75.
- - Inanc N, Aydin SZ, Karakurt S, Atagunduz P, Yavuz S, Direskeneli H. Agreement between Quantiferon-TB gold test and tuberculin skin test in the identification of latent tuberculosis infection in patients with rheumatoid arthritis and ankylosing spondylitis. J Rheumatol. 2009;36(12):2675-81.
- - Chang B, Park HY, Jeon K, Ahn JK, Cha HS, Koh EM et al. Interferon-γ release assay in the diagnosis of latent tuberculosis infection in arthritis patients treated with tumor necrosis factor antagonists in Korea. Clin Rheumatol. 2011;30(12):1535-41.
- - Lee H, Park HY, Jeon K, Jeong BH, Hwang JW, Lee J et al. QuantiFERON-TB Gold In-Tube assay for screening arthritis patients for latent tuberculosis infection before starting anti tumor necrosis factor treatment. PLoS One. 2015;10(3):e0119260.
- - Jeong DH, Kang J, Jung YJ, Yoo B, Lee CK, Kim YG et al. Comparison of latent tuberculosis infection screening strategies before tumor necrosis factor inhibitor treatment in inflammatory arthritis: IGRA alone versus combination of TST and IGRA. PLoS One. 2018;13(7):e0198756.
- - Kim HC, Jo KW, Jung YJ, Yoo B, Lee CK, Kim YG, et al. Diagnosis of latent tuberculosis infection before initiation of anti-tumor necrosis factor therapy using both tuberculin skin test and QuantiFERON-TB Gold In Tube assay. Scand J Infect Dis. 2014;46(11):763-9.
- - Costantino F, de Carvalho Bittencourt M, Rat AC, Loeuille D, Dintinger H, Béné MC et al. Screening for latent tuberculosis infection in patients with chronic inflammatory arthritis: discrepancies between tuberculin skin test and interferon-γ release assay results. J Rheumatol. 2013;40(12):1986-93.
- - Hsia EC, Schluger N, Cush JJ, Chaisson RE, Matteson EL, Xu S, et al. Interferon-γ release assay versus tuberculin skin test prior to treatment with golimumab, a human anti-tumor necrosis factor antibody, in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. Arthritis Rheum. 2012;64(7):2068-77.
- - García-Gasalla, Fernández-Baca V, Juan-Mas A, Payeras-Cifre A, Cifuentes-Luna C, Taberner-Ferrer R, et al. Use of Quantiferon-TB-Gold in Tube(®) test for detecting latent tuberculosis in patients considered as candidates for anti-TNF therapy in routine clinical practice. Enferm Infecc Microbiol Clin. 2013;31(2):76-81.
- - Ruan Q, Zhang S, Ai J, Shao L, Zhang W. Screening of latent tuberculosis infection by interferon-γ release assays in rheumatic patients: a systemic review and meta-analysis. Clin Rheumatol. 2016;35(2):417-25.
- - Costa L, Caso F, Atteno M. Long-term safety of anti-TNF-α in PsA patients with concomitant HCV infection: a retrospective observational multicenter study on 15 patients. Clin Rheumatol. 2014;33:273-6.
- - Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79:39-52.
- - van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76:978–91.
- - JA Singh, G Guyatt, A Ogdie, DD Gladman, C Deal, A Deodhar, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
- - GE Fragoulis, S Siebert. Treatment strategies in axial spondyloarthritis:what, when and how? Rheumatology. 2020;59:79–89.
- - Wang R, Dasgupta A, Ward MM. Comparative efficacy of tumor necrosis factor-a inhibitors in ankylosing spondylitis: a systematic review and bayesian network metaanalysis. J Rheumatol. 2018;45:481–90.
- - Cruz-Machado AR, Rodrigues-Manica S, Silva JL, Alho I, Coelho C, Duarte J, et al. Effect of biologic disease-modifying antirheumatic drugs targeting remission in axial spondyloarthritis: systematic review and meta-analysis. Rheumatology (Oxford). 2020;59(11):3158-71.
- - Simons N, Degboé Y, Barnetche T, Cantagrel A, Ruyssen-Witrand A, Constantin A. Biological DMARD efficacy in psoriatic arthritis: a systematic literature review and meta-analysis on articular, enthesitis, dactylitis, skin and functional outcomes. Clin Exp Rheumatol. 2020;38(3):508-15.
- - Hou LQ, Jiang GX, Chen YF, Yang XM, Meng L, Xue M, 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.
- - Qiu M, Xu Z, Gao W, Xiong M, Wen X, Zhu W, et al. Fourteen small molecule and biological agents for psoriatic arthritis: A network meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020;99(31):e21447.
- - Wu D, Li C, Zhang S,Wong P, Cao Y, Griffith JF, et al. Effect of biologics on radiographic progression of peripheral joint in patients with psoriatic arthritis: meta-analysis. Rheumatology (Oxford). 2020;59(11):3172-80
- - Mease PJ, Smolen JS, Behrens F, Nash P, Leage SL, Li L, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriaticarthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79:123–31.
- - McInnes IB, Behrens F, Mease PJ, Kavanaugh A, Ritchlin C, Nash P, et al. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active controlled, phase 3b trial. Lancet. 2020; 395:1496–505.
- - Ren L, Li J, Luo R, Tang R, Zhu S, Wan L. Efficacy of Antitumor Necrosis Factor(a) Agents on Patients With Ankylosing Spondylitis. Am J Med Sci. 2013; 346(6):455-61.
- - 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. International Journal of Rheumatic Diseases. 2014; 17:142–8.
- - Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Lenaerts J, et al. Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study. Arthritis Care Res. 2017; 69(10):1590-8.
- - Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, et al. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial spondyloarthritis. Arthritis Care Res. 2015; 67(10): 1475–80.
- - Sieper J, van der Heijde D, Dougados M, Maksymowych WP, Scott BB, Boice JA, et al. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015;67(10):2702-12.
- - van der Heijde D, Breban M, Halter D, DiVittorio G, Bratt J, Cantini F, 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;54:1210-9.
- - Chen C, Zhang X, Xiao L, Zhang X, Ma X. Comparative Effectiveness of Biologic Therapy Regimens for Ankylosing Spondylitis: A Systematic Review and a Network Meta-Analysis. Medicine (Baltimore). 2016;95(11):e3060.
- - Kawalec P, Holko P, Moćko P, Pilc A. Comparative effectiveness of abatacept, apremilast, secukinumab and ustekinumab treatment of psoriatic arthritis: a systematic review and network metaanalysis. Rheumatol Int. 2017;38(2):189-201.
- - Ungprasert P, Thongprayoon C, Davis JM. Indirect comparisons of the efficacy of biological agents in patients with psoriatic arthritis with an inadequate response to traditional disease-modifying anti-rheumatic drugs or to non-steroidal anti-inflammatory drugs: A meta-analysis. Semin Arthritis Rheum. 2016; 45(4):428-38.
- - Qu X, Zhang S, Tao L, Song Y. A meta-analysis of apremilast on psoriatic arthritis long-term assessment of clinical efficacy (PALACE). Expert Rev Clin Pharmacol. 2016;9(6):799-805.
- - Deodhar A, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, doubleblind, placebo-controlled, phase 2 study. Lancet. 2018;391(10136):2213-24.
- - Deodhar A, van der Heijde D, Gensler LS, Kim TH, Maksymowych WP, Østergaard M, et al. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64.
- - Cawson MR, Mitchell SA, Knight C, Wildey H, Spurden D, Bird A, et al. Systematic review, network meta-analysis and economic evaluation of biological therapy for the management of active psoriatic arthritis. BMC Musculoskelet Disord. 2014;15:26.
- - Goulabchand R, Mouterde G, Barnetche T, Lukas C, Morel J, Combe B, et al. Effect of tumour necrosis factor blockers on radiographic progression of psoriatic arthritis: a systematic review and meta-analysis of randomised controlled trials. Ann Rheum Dis. 2014;73:414–9.
- - Carron P, Varkas G, Cypers H, Praet LV, Elewaut D, Van den Bosch F, et al. Anti-TNF-induced remission in very early peripheral spondyloarthritis: the CRESPA study. Ann Rheum Dis. 2017;76(8):1389-95.
- - Damjanov N, Karpati S, Kemeny L, Bakos N, Bobic B, Majdan M, et al. Efficacy and safety of etanercept in psoriasis and psoriatic arthritis in the PRESTA study: Analysis in patients from Central and Eastern Europe. J Dermatolog Treat. 2018; 29(1):8-12.
- - K Maatallah, I Mahmoud , S Belghali, Ben Abdelghani K, Saidane O, Bouajina E2, et al. Reparative radiological changes of hip joint after TNF inhibitors in ankylosing spondylitis. Caspian J Intern Med. 2018;9(3):303–5.
- - Wu D, Yue J, Tam LS. Efficacy and safety of biologics targeting interleukin-6, -12/23 and -17pathways for peripheral psoriatic arthritis: a network meta-analysis. Rheumatology(Oxford). 2018;57(3):563-71.
- - McInnes IB, Mease PJ, Ritchlin CT, Rahman P, Gottlieb AB, Kirkham B, et al. Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study. Rheumatology (Oxford). 2017;56(11):1993-2003.
- - McInnes IB, Puig L, Gottlieb AB, Ritchlin CT, Song M, You Y, et al. Association between enthesitis and health-related quality of life in psoriatic arthritis in anti-TNF-naïve patients from two Phase 3 ustekinumab trials. J Rheumatol. 2019;46(11):1458-61.
- - Xu M, Lin Z, Deng X, Li L, Wei Y, Liao Z, et al. The Ankylosing Spondylitis Disease Activity Score is a highly discriminatory measure of disease activity and efficacy following tumour necrosis factor-α inhibitor therapies in ankylosing spondylitis and undifferentiated spondyloarthropathies in China. Rheumatology (Oxford). 2011;50(8):1466-72.
- - van der Heijde D, Braun J, Dougados M, Sieper J, Pedersen R, Szumski A, et al. Sensitivity and discriminatory ability of the Ankylosing Spondylitis Disease Activity Score in patients treated with etanercept or sulphasalazine in the ASCEND trial. Rheumatology (Oxford). 2012;51(10):1894-905.
- - Moreno M, Gratacós J, Torrente-Segarra V, Sanmarti R, Morlà R, Pontes C, et al. Withdrawal of infliximab therapy in ankylosing spondylitis in persistent clinical remission, results from the REMINEA study. Arthritis Res Ther. 2019;21(1):88.
- - Perrotta FM, Marchesoni A, Lubrano E. Minimal Disease Activity and Remission in Psoriatic Arthritis Patients Treated with Anti-TNF-α Drugs. J Rheumatol. 2016; 43(2):350-5.
- - Queiro R, Cañete JD, Montilla C, Abad M, Montoro M, Gómez S, et al. Minimal disease activity and impact of disease in psoriatic arthritis: a Spanish cross-sectional multicenter study. Arthritis Res Ther. 2017;19(1):72.
- - Lubrano E, De Socio A, Perrotta FM. Comparison of Composite Indices Tailored for Psoriatic Arthritis Treated with csDMARD and bDMARD: A Cross-sectional Analysis of a Longitudinal Cohort. J Rheumatol. 2017;44(8):1159-64.
- - Wervers K, Vis M, Tchetveriko I, Gerards AH, Kok MR, Appels CWY, et al. Burden of Psoriatic Arthritis According to Different Definitions of Disease Activity: Comparing Minimal Disease Activity and the Disease Activity Index for Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2018;70(12):1764-70.
- - Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016;75(5):811-8.
- - Gratacós J, Pontes C, Juanola X, Sanz J, Torres F, Avendaño C, et al. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019;21(1):11
- - Lie E, van der Heijde D, Uhlig T, Mikkelsen K, Rødevand E, Koldingsnes W, et al. Effectiveness of Switching Between TNF Inhibitors in Ankylosing Spondylitis: Data From the NOR-DMARD Register. Ann Rheum Dis. 2011;70(1):157-63
- - Reddy SM, Crean S, Martin AL, Burns MD, Jacqueline B Palmer JB. Realworld Effectiveness of anti-TNF Switching in Psoriatic Arthritis: A Systematic Review of the Literature. Clin Rheumatol. 2016;35(12):2955-66.
- - Deodhar A, Yu D. Switching Tumor Necrosis Factor Inhibitors in the Treatment of Axial Spondyloarthritis. Semin Arthritis Rheum. 2017;47(3):343-50.
- - Edwards CJ, Fautrel B, Schulze-Koops H, Huizinga TWJ, Kruger K. Dosing down with biologic therapies: a systematic review and clinicans’ persperctive. Rheumatology. 2017; 56:1847-56.
- - Haibel H, Heldmann F, Braun J, Listing J, Kupper H, Sieper J. Long term efficacy of adalimumab after drug withdrawal and retreatment in patients with active non radiographically evident axial spondyloarthritis who experience a flare. Arthritis Rheum. 2013;65(8):2211-3.
- - Song IH, Haibel H, Poddubnyy D, Braun J, Sieper J. Withdrawal of biologic therapy in axial spondyloarthritis: the experience in early disease. Clin Exp Rheumatol. 2013;31:S37-42.
- - Song IH, Althoff CE, Haibel H, Hermann KG, Poddubnyy D, Listing J et al. Frequency and duration of drug-free remission after 1 year of treatment with etanercept versus sulfasalazine in early axial spondyloarthritis: 2 year data of the ESTHER trial. Ann Rheum Dis. 2012;71(7):1212-5.
- - Zhao M, Zhang P, Fang L, Luo Z, Gu J, Lin Z. Possible predictors for relapse from etanercept discontinuation in ankylosing spondylitis patients in remission: a three years' following-up study. Clin Rheumatol. 2018;37(1):87-92.
- - Baraliakos X, Listing J, Brandt J, Rudwaleit M, Sieper J, Braun J. Clinical response to discontinuation of anti-TNF therapy in patients with ankylosing spondylitis after 3 years of continuous treatment with infliximab. Arthritis Res Ther. 2005;7(3):R439-44.
- - Baraliakos X, Listing J, Rudwaleit M, Brandt J, Alten R, Burmester G, et al. Safety and efficacy of readministration of infliximab after longterm continuous therapy and withdrawal in patients with ankylosing spondylitis. J Rheumatol. 2007;34:510-5.
- - Landewé R, Sieper J, Mease P, Inman RD, Lambert RG, Deodhar A et al. Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with nonradiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study. Lancet. 2018;392(10142):134-44.
- - JM Berthelot, De Bandt M, Goupille P, Solau-Gervais E, Lioté F, Goeb V, et al. Exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature. Joint Bone Spine. 2009;76(1):28-34.
- - Hoxha A, Calligaro A, Di Poi E, Peccatori S, Favaro M, Del Ross T, et al. Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study. Joint Bone Spine. 2017;84(2):169-73.
- - Genest G, Spitzer KA, Laskin CA. Maternal and Fetal Outcomes in a Cohort of Patients Exposed to Tumor Necrosis Factor Inhibitors throughout Pregnancy. J Rheumatol. 2018;45(8):1109-15.
- - Warren RB, Reich K, Langley RG, Strober B, Gladman D, Deodhar A, et al. Secukinumab in pregnancy: outcomes in psoriasis, psoriatic arthritis and ankylosing spondylitis from the global safety database. Br J Dermatol. 2018;179(5):1205-7.
- - Deng C, Li W, Fei Y, Li Y, Zhang F. Risk of malignancy in ankylosing spondylitis: a systematic review and meta-analysis. Sci Rep. 2016;18(6):32063
- - Luo X, Deng C, Fei Y, Zhang W, Li Y, Zhang X, et al. Malignancy development risk in psoriatic arthritis patients undergoing treatment: A systematic review and metaanalysis. Semin Arthritis Rheum. 2019;48(4):626-31.