Safety of tumor necrosis factor inhibitors use for rheumatoid arthritis and ankylosing spondylitis in Africa, the Middle East, and Asia: focus on severe infections and tuberculosis
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Multiple studies of patients in Western countries with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) have indicated increased risk for active tuberculosis (TB) and other infections among these individuals. It has also been consistently reported that patients receiving tumor necrosis factor (TNF) inhibitors for these conditions have higher rates of active TB and other infections than RA or AS patients not receiving these medications. These issues have been studied less extensively in the Asia and Africa–Middle East regions, and information from these regions is important because of higher rates of TB in the general population. This paper reviews studies of RA and AS patients from Asia, Africa, and the Middle East who received TNF inhibitors. A literature search was conducted using http://www.ncbi.nlm.nih.gov/pubmed to collect and report these data. The years included in the PubMed literature search ranged from January 2000 to October 2011. Additionally, information from the China Hospital Knowledge Database was used to report data from Chinese patients with RA and AS treated with TNF inhibitors. Results from these studies indicate that the risk for active TB and other infections in AS and RA patients from Asia, Africa, and the Middle East are increased in patients receiving TNF inhibitors and that the risk is higher among those treated with monoclonal antibodies versus soluble TNF receptor.
KeywordsAdalimumab Ankylosing spondylitis Etanercept Infliximab Rheumatoid Tuberculosis
Editorial/medical writing support was provided by WC Hatch at ACUMED and was funded by Pfizer Inc. No financial support was provided to the authors for this work.
Abdurhman Alarfaj has consulted and received honorarium from Pfizer Inc. Mohammed Hammoudeh has consulted for Schering-Plough Corp and consulted and received honoraria from Abbott Laboratories, Pfizer Inc, Roche Pharmaceuticals, and Wyeth Pharmaceuticals. He has received grant/research support from Pfizer Inc, Roche Pharmaceuticals, Schering-Plough Corp, and Wyeth Pharmaceuticals. Ehab Youseif is a Senior Regional Director, Medical Affairs for Pfizer Latin America. Der-Yuan Chen, Hachemi Djoudi, and Jian Zhu declare no conflicts of interest.
- 3.Symmons D, Mathers C, Pfleger B (2006) The global burden of rheumatoid arthritis in the year 2000. Working Paper, World Health Organization, Geneva www.who.int/healthinfo/statistics/bod_rheumatoidarthritis.pdf. Accessed 26 Apr 2012
- 11.Younsi R, Azrib S, Aitouazar M, Hari WG, El Hassani S (2007) Evaluation de ’incidence du gène HLA-B27 chez le patient attaint de spondlyarthrite ankylosante au Maroc. Revue de Rhumatisme 74:1013Google Scholar
- 16.Gliklich RE, Dreyer NA et al (2010) Registries for evaluating patient outcomes: a user’s guide. Agency for Healthcare Research and Quality (US), RockvilleGoogle Scholar
- 17.Singh JA, Wells GA, Christensen R et al (2011) Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev: CD008794Google Scholar
- 19.United Nations (2009) Tuberculosis prevalence rate per 100,000 population (mid-point) http://data.un.org/Data.aspx?d=MDG&f=seriesRowID%3A617. Accessed 26 Apr 2012
- 20.Dabbous O, Gilmer K, Tatsuki Y et al (2007) Tuberculosis in Japanese patients with rheumatoid arthritis treated with infliximab: findings from the post marketing surveillance trial. 2007 Annual ACR MeetingGoogle Scholar
- 21.Komano Y, Tanaka M, Nanki T et al (2011) Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 38:1258–1264PubMedCrossRefGoogle Scholar
- 23.Hu DW, Bao CD, Chen SL et al (2005) Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor-Fc fusion protein: a multicenter, randomized, double blind, controlled trial. Chin J Rheumatol 9:664–668Google Scholar
- 24.Hou Y, Zhang FC, Huang F et al (2005) Infliximab versus placebo in rheumatoid arthritis receiving concomitant methotrexate: a randomized double blind phase III trial in China. Chin J Rheumatol 10:658–663Google Scholar
- 28.Wang LS, Huang F, Zhang JL et al (2007) A cohort analysis of safety tumor necrosis factor- antagonists in the treatment of Chinese patients with ankylosing spondylitis. Chin J New Drugs 16:556–561Google Scholar
- 29.Chen DY, Chou SJ, Hsieh TY et al (2009) Randomized, double-blind, placebo-controlled, comparative study of human anti-TNF antibody adalimumab in combination with methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis. J Formos Med Assoc 108:310–319PubMedCrossRefGoogle Scholar
- 30.Chen DY, Shen GH, Hsieh TY, Hsieh CW, Lan JL (2008) Effectiveness of the combination of a whole-blood interferon-gamma assay and the tuberculin skin test in detecting latent tuberculosis infection in rheumatoid arthritis patients receiving adalimumab therapy. Arthritis Rheum 59:800–806PubMedCrossRefGoogle Scholar
- 32.Navarra S, Raso AA, Linchauco JJ, Tan P (2006) Clinical experience with infliximab among Filipino patients with rheumatic diseases. Int J Rheumatic Dis 9:150–156Google Scholar
- 37.Allali F, Rkain H, Faik A, El Hassani S, Hajjaj-Hassouni N (2005) Prevalence and clinical characteristics of tuberculosis in rheumatoid arthritis patients. Clin Rheumatol 24:656–657Google Scholar
- 39.Public Health Agency of Canada (2011) International tuberculosis incidence rates. http://www.phac-aspc.gc.ca/tbpc-latb/itir-eng.php. Accessed 17 Jul 2012
- 41.Galloway JB, Hyrich KL, Mercer LK et al (2011) Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatol (Oxford) 50:124–131CrossRefGoogle Scholar
- 48.Winthrop KL (2010) The risk and prevention of tuberculosis: screening strategies to detect latent tuberculosis among rheumatoid arthritis patients who use biologic therapy. Int J Adv Rheumatol 8:43–52Google Scholar
- 50.Tubach F, Salmon D, Ravaud P et al (2009) Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: the three-year prospective French Research Axed on Tolerance of Biotherapies Registry. Arthritis Rheum 60:1884–1894Google Scholar