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Clinical Rheumatology

, Volume 31, Issue 3, pp 407–416 | Cite as

The practical value of biologics registries in Africa and Middle East: challenges and opportunities

  • Najia Hajjaj-HassouniEmail author
  • Marzooq Al-Badi
  • Ala’ Al-Heresh
  • Samar Al-Emadi
  • Ahmed El Bawendi
  • Ayman El Garf
  • Khaled El Hadidi
  • Hussein Halabi
  • Mohammed Hammoudeh
  • Selma El Hassani
  • Mustafa Al Maaini
  • Ibrahim Nahar
  • Aïcha Ladjouze Rezig
  • Slaheddine Sellami
  • Wafaa Sweiri
  • Ramiz Alswailem
  • Beverly Traub
  • Imad Uthman
  • Elsa van Duuren
  • Leith Zakraoui
  • Bassel El Zorkany
  • Loreto Carmona
  • Maxime Dougados
Review Article

Abstract

Biologics, including tumor necrosis factor (TNF) inhibitors, are increasingly used for the treatment of inflammatory conditions such as rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis. The efficacy of these drugs has been demonstrated in randomized controlled trials (RCTs). However, these studies are conducted in controlled environments, and the results may not necessarily reflect clinical outcomes in daily clinical practice. In Europe and other western countries, numerous biologics registries that enroll and monitor patients receiving biologics have been established. These registries follow patients irrespective of whether they continue with the initial biologic drug. Thus, real-life efficacy data from these registries can be used to assess the long-term safety of biologics through longitudinal studies. In Africa and Middle East (AFME), such registries currently exist only in Morocco and South Africa. In light of the increasing availability of biologics and scarcity of long-term safety data of these agents in the AFME population, there is a need to establish biologics registries in other countries across the region. This review discusses the value of biologics registries versus RCTs as well as safety and efficacy data from observational studies presented as lessons from well-established biologics registries. In addition, the rationale for establishing such registries in the AFME region is also presented.

Keywords

Africa and Middle East Biologics Registries Rheumatoid arthritis Safety Tumor necrosis factor inhibitors 

Notes

Acknowledgements

We would like to thank Dr. Pradnya Kulkarni from UBM Medica for editorial support. Funding for the initial working group meeting and editorial support was provided by Pfizer.

Disclosures

None.

References

  1. 1.
    The environment and the middle East. Regional and international cooperation, volume 111. Middle East Institute 2011. Available at http://www.mei.edu/LinkClick.aspx?fileticket=PHoihEEf1CI%3D&tabid=541. Accessed 31 July 2011
  2. 2.
    The Work of WHO in the Eastern Mediterranean Region: annual report of the regional director, 1 January-31 December 2009. Available at http://www.emro.who.int/rd/annualreports/2009/Introduction.htm. Accessed 31 July 2011
  3. 3.
    Maziak W (2006) Health in the Middle East. BMJ 333:815–816PubMedCrossRefGoogle Scholar
  4. 4.
    Achieving sustainable health development in the African region strategic directions for WHO 2010–2015. World Health Organization regional office for Africa, Brazzaville, 2010. Available at http://www.afro.who.int/index.php?option=com_content&view=article&id=2871:towards-reaching-the-health-related-mdgs&catid=1893&Itemid=2673. Accessed 31 July 2011
  5. 5.
    Symmons D, Mathers C, Pfleger B (2000) The global burden of rheumatoid arthritis in the year 2000. Available at http://www.who.int/healthinfo/statistics/bod_rheumatoidarthritis.pdf. Accessed 1 August 2011
  6. 6.
    Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, Gorter S, Knevel R, Nam J, Schoels M, Aletaha D, Buch M, Gossec L, Huizinga T, Bijlsma JW, Burmester G, Combe B, Cutolo M, Gabay C, Gomez-Reino J, Kouloumas M, Kvien TK, Martin-Mola E, McInnes I, Pavelka K, van Riel P, Scholte M, Scott DL, Sokka T, Valesini G, van Vollenhoven R, Winthrop KL, Wong J, Zink A, van der Heijde D (2010) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 69(6):964–975PubMedCrossRefGoogle Scholar
  7. 7.
    Scott DL (2009) What have we learnt about the development and progression of early RA from RCTs? Best Pract Res Clin Rheumatol 23:13–24PubMedCrossRefGoogle Scholar
  8. 8.
    Kvien TK, Heiberg MS, Lie E, Kaufmann C, Mikkelsen K, Nordvåg BY, Rødevand E (2005) A Norwegian DMARD register: prescriptions of DMARDs and biological agents to patients with inflammatory rheumatic diseases. Clin Exp Rheumatol 23(Suppl 39):S188–S194PubMedGoogle Scholar
  9. 9.
    Listing J, Strangfeld A, Rau R, Kekow J, Gromnica-Ihle E, Klopsch T, Demary W, Burmester G, Zink A (2006) Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low—results from RABBIT, the German biologics register. Arthritis Res Ther 8:R66PubMedCrossRefGoogle Scholar
  10. 10.
    Kievit W, Fransen J, Oerlemans AJM, Kuper HH, van der Laar MAFJ, de Rooij DJRAM, De Gendt CMA, Ronday KH, Jansen TL, van Oijen PCM, Brus HLM, Adang EM, van Riel PLCM (2007) The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice. Ann Rheum Dis 66:1473–1478PubMedCrossRefGoogle Scholar
  11. 11.
    Zink A, Askling J, Dixon WG, Klareskog L, Silman AJ, Symmons DP (2009) European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 68(8):1240–1246PubMedCrossRefGoogle Scholar
  12. 12.
    Askling J, Baecklund E, Granath F, Geborek P, Fored M, Backlin C, Bertilsson L, Cöster L, Jacobsson LT, Lindblad S, Lysholm J, Rantapää-Dahlqvist S, Saxne T, van Vollenhoven R, Klareskog L, Feltelius N (2009) Anti-tumour necrosis factor therapy in rheumatoid arthritis and risk of malignant lymphomas: relative risks and time trends in the Swedish Biologics Register. Ann Rheum Dis 68(5):648–653PubMedCrossRefGoogle Scholar
  13. 13.
    Askling J, Fored CM, Geborek P, Jacobsson LT, van Vollenhoven R, Feltelius N, Lindblad S, Klareskog L (2006) Swedish registers to examine drug safety and clinical issues in RA. Ann Rheum Dis 65(6):707–712PubMedCrossRefGoogle Scholar
  14. 14.
    Gómez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD, BIOBADASER Group (2003) Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum 48(8):2122–2127PubMedCrossRefGoogle Scholar
  15. 15.
    Marchesoni A, Zaccara E, Gorla R, Bazzani C, Sarzi-Puttini P, Atzeni F, Caporali R, Bobbio-Pallavicini F, Favalli EG (2009) TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci 1173:837–846PubMedCrossRefGoogle Scholar
  16. 16.
    Brennan A, Bansback N, Nixon R, Madan J, Harrison M, Watson K, Symmons D (2007) Modelling the cost effectiveness of TNF-alpha antagonists in the management of rheumatoid arthritis: results from the British Society for Rheumatology Biologics Registry. Rheumatology (Oxford) 46(8):1345–1354CrossRefGoogle Scholar
  17. 17.
    Karlsson JA, Kristensen LE, Kapetanovic MC, Gülfe A, Saxne T, Geborek P (2008) Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford) 47(4):507–513CrossRefGoogle Scholar
  18. 18.
    Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, Kollerup G, Linde L, Lindegaard HM, Poulsen UE, Schlemmer A, Jensen DV, Jensen S, Hostenkamp G, Østergaard M, All Departments of Rheumatology in Denmark (2010) Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from 8 years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum 62(1):22–32PubMedCrossRefGoogle Scholar
  19. 19.
    Dixon WG, Carmona L, Finckh A, Hetland ML, Kvien TK, Landewe R, Listing J, Nicola PJ, Tarp U, Zink A, Askling J (2010) EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis 69(9):1596–1602 (Dixon 2010a)PubMedCrossRefGoogle Scholar
  20. 20.
    Dixon WG, Watson K, Lunt M, Hyrich KL, Silman AJ, Symmons DP, British Society for Rheumatology Biologics Register (2006) Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 54(8):2368–2376PubMedCrossRefGoogle Scholar
  21. 21.
    Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Watson KD, Lunt M; BSRBR Control Centre Consortium, Symmons DP; on behalf of the British Society for Rheumatology Biologics Register (2011) The risk of serious infections in patients receiving anakinra for rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Rheumatology (Oxford) 50 (7):1341–1342CrossRefGoogle Scholar
  22. 22.
    Dixon WG, Symmons DP, Lunt M, Watson KD, Hyrich KL; British Society for Rheumatology Biologics Register Control Centre Consortium, Silman AJ; British Society for Rheumatology Biologics Register (2007) Serious infection following anti-tumor necrosis factor alpha therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum 56(9):2896–2904PubMedCrossRefGoogle Scholar
  23. 23.
    Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Bréban M, Pallot-Prades B, Pouplin S, Sacchi A, Chichemanian RM, Bretagne S, Emilie D, Lemann M, Lortholary O, Mariette X, Research Axed on Tolerance of Biotherapies Group (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(7):1884–1894PubMedCrossRefGoogle Scholar
  24. 24.
    Dixon WG, Hyrich KL, Watson KD, Lunt M, Galloway J, Ustianowski A; B S R B R Control Centre Consortium, Symmons DP; BSR Biologics Register (2010) Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis 69(3):522–528PubMedCrossRefGoogle Scholar
  25. 25.
    Strangfeld A, Listing J, Herzer P, Liebhaber A, Rockwitz K, Richter C, Zink A (2009) Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA 301(7):737–744PubMedCrossRefGoogle Scholar
  26. 26.
    García-Doval I, Pérez-Zafrilla B, Descalzo MA, Roselló R, Hernández MV, Gómez-Reino JJ, Carmona L, BIOBADASER 2.0 Study Group (2010) Incidence and risk of hospitalisation due to shingles and chickenpox in patients with rheumatic diseases treated with TNF antagonists. Ann Rheum Dis 69(10):1751–1755PubMedCrossRefGoogle Scholar
  27. 27.
    Pallavicini FB, Caporali R, Sarzi-Puttini P, Atzeni F, Bazzani C, Gorla R, Marchesoni A, Favalli EG, Montecucco C (2010) Tumour necrosis factor antagonist therapy and cancer development: analysis of the LORHEN registry. Autoimmun Rev 9(3):175–180PubMedCrossRefGoogle Scholar
  28. 28.
    Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V (2006) Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 295(19):2275–2285PubMedCrossRefGoogle Scholar
  29. 29.
    Askling J, Fahrbach K, Nordstrom B, Ross S, Schmid CH, Symmons D (2011) Cancer risk with tumor necrosis factor alpha (TNF) inhibitors: meta-analysis of randomized controlled trials of adalimumab, etanercept, and infliximab using patient level data. Pharmacoepidemiol Drug Saf 20(2):119–130PubMedCrossRefGoogle Scholar
  30. 30.
    Carmona L, Abasolo L, Descalzo MA, Pérez-Zafrilla B, Sellas A, de Abajo F, Gomez-Reino JJ, BIOBADASER Study Group; EMECAR Study Group (2011) Cancer in patients with rheumatic diseases exposed to TNF antagonists. Semin Arthritis Rheum 41(1):71–80PubMedCrossRefGoogle Scholar
  31. 31.
    Dixon WG, Watson KD, Lunt M, Mercer LK, Hyrich KL, Symmons DP, British Society For Rheumatology Biologics Register Control Centre Consortium; British Society for Rheumatology Biologics Register (2010) Influence of anti-tumor necrosis factor therapy on cancer incidence in patients with rheumatoid arthritis who have had a prior malignancy: results from the British Society for Rheumatology Biologics Register. Arthritis Care Res (Hoboken) 62(6):755–763CrossRefGoogle Scholar
  32. 32.
    Salmon-Ceron D, Tubach F, Lortholary O, Chosidow O, Bretagne S, Nicolas N, Cuillerier E, Fautrel B, Michelet C, Morel J, Puéchal X, Wendling D, Lemann M, Ravaud P, Mariette X, RATIO group (2011) Drug-specific risk of non-tuberculosis opportunistic infections in patients receiving anti-TNF therapy reported to the 3-year prospective French RATIO registry. Ann Rheum Dis 70(4):616–623PubMedCrossRefGoogle Scholar
  33. 33.
    Bernatsky S, Habel Y, Rahme E (2010) Observational studies of infections in rheumatoid arthritis: a metaanalysis of tumor necrosis factor antagonists. J Rheumatol 37(5):928–931PubMedCrossRefGoogle Scholar
  34. 34.
    Ornbjerg LM, Ostergaard MB, Boyesen M, Thormann P, Tarp A, Bohme U, Dencker WD (2010) Treatment with TNF inhibitors reduces radiographic joint destruction in rheumatoid arthritis patients treated in clinical practice. Arthritis Rheum 62(suppl 10):1841Google Scholar
  35. 35.
    Lie EU, Mikkelsen T, Kalstaa K, Rodevand S, Kaufmann E, Kvien C, Tore K (2010) Better results are achieved by switching directly to biologics than switching via DMARD combinations in RA patients who have failed methotrexate as their initial DMARD: real life data from NOR-DMARD. Arthritis Rheum 62(suppl 10):377Google Scholar
  36. 36.
    Strangfeld A, Hierse F, Kekow J, von Hinueber U, Tony HP, Dockhorn R, Listing J, Zink A (2009) Comparative effectiveness of tumour necrosis factor alpha inhibitors in combination with either methotrexate or leflunomide. Ann Rheum Dis 68(12):1856–1862PubMedCrossRefGoogle Scholar
  37. 37.
    Carmona L, Descalzo MA, Perez-Pampin E, Ruiz-Montesinos D, Erra A, Cobo T, Gómez-Reino JJ, BIOBADASER and EMECAR Groups (2007) All-cause and cause-specific mortality in rheumatoid arthritis are not greater than expected when treated with tumour necrosis factor antagonists. Ann Rheum Dis 66(7):880–885PubMedCrossRefGoogle Scholar
  38. 38.
    Dixon WG, Watson KD, Lunt M, Hyrich KL; British Society for Rheumatology Biologics Register Control Centre Consortium, Silman AJ, Symmons DP; British Society for Rheumatology Biologics Register (2007) Reduction in the incidence of myocardial infarction in patients with rheumatoid arthritis who respond to anti-tumor necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 56(9):2905–2912PubMedCrossRefGoogle Scholar
  39. 39.
    Jacobsson LT, Turesson C, Nilsson JA, Petersson IF, Lindqvist E, Saxne T, Geborek P (2007) Treatment with TNF blockers and mortality risk in patients with rheumatoid arthritis. Ann Rheum Dis 66(5):670–675PubMedCrossRefGoogle Scholar
  40. 40.
    Badsha H, Kong KO, Tak PP (2008) Rheumatoid arthritis in the United Arab Emirates. Clin Rheumatol 27(6):739–742PubMedCrossRefGoogle Scholar
  41. 41.
    Global tuberculosis control. World Health Organization Report 2010. Available at http://www.who.int/tb/publications/global_report/2010/en/index.html. Accessed 3 August 2011
  42. 42.
    World Health Organization, Regional Committee for the Eastern Mediterranean, The growing threats of hepatitis B and C in the Eastern Mediterranean Region: a call for action. Available at http://www.emro.who.int/rc56/media/pdf/emrc56r5.pdf. Accessed on 10 July 2011
  43. 43.
    Kramvis A, Kew MC (2007) Epidemiology of hepatitis B virus and its genotypes in Africa, and the clinical associations of the genotypes. Hepatol Res 37:S9–S19, AbstractPubMedCrossRefGoogle Scholar
  44. 44.
    Madhava V, Burgess C, Drucker E (2002) Epidemiology of chronic hepatitis C virus infection in sub-Saharan Africa. Lancet Infect Dis 2(5):293–302PubMedCrossRefGoogle Scholar
  45. 45.
    Coffin CS, Fraser HF, Panaccione R, Ghosh S (2011) Liver diseases associated with anti-tumor necrosis factor-alpha (TNF-α) use for inflammatory bowel disease. Inflamm Bowel Dis 17(1):479–484PubMedCrossRefGoogle Scholar
  46. 46.
    World Health Organization. Regional Office for the Eastern Mediterranean Region. Cardiovascular diseases. Available at http://www.emro.who.int/ncd/cardiovascular_diseases.htm. Accessed on 10 July 2011
  47. 47.
    World Health Organization 2011, Media Centre, Cardiovascular Diseases, Fact Sheets. Available at http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Accessed on 10 July 2011

Copyright information

© Clinical Rheumatology 2012

Authors and Affiliations

  • Najia Hajjaj-Hassouni
    • 1
    • 2
    Email author
  • Marzooq Al-Badi
    • 3
  • Ala’ Al-Heresh
    • 4
  • Samar Al-Emadi
    • 5
  • Ahmed El Bawendi
    • 8
  • Ayman El Garf
    • 10
  • Khaled El Hadidi
    • 11
  • Hussein Halabi
    • 12
  • Mohammed Hammoudeh
    • 13
  • Selma El Hassani
    • 14
  • Mustafa Al Maaini
    • 7
  • Ibrahim Nahar
    • 15
  • Aïcha Ladjouze Rezig
    • 16
  • Slaheddine Sellami
    • 17
  • Wafaa Sweiri
    • 18
  • Ramiz Alswailem
    • 6
  • Beverly Traub
    • 19
  • Imad Uthman
    • 20
  • Elsa van Duuren
    • 9
  • Leith Zakraoui
    • 21
  • Bassel El Zorkany
    • 22
  • Loreto Carmona
    • 23
  • Maxime Dougados
    • 24
  1. 1.University Mohammed Vth SouissiRabatMorocco
  2. 2.El Ayachi HospitalSaléMorocco
  3. 3.Security Force HospitalRiyadhSaudi Arabia
  4. 4.King Hussein Medical Center, Royal Medical ServicesAmmanJordan
  5. 5.Weill Cornell Medical SchoolDohaQatar
  6. 6.Riyadh Military HospitalRiyadhSaudi Arabia
  7. 7.Mafraq HospitalAbu DhabiUnited Arab Emirates
  8. 8.Tripoli Medical CenterTripoliLibya
  9. 9.Jakaranda HospitalPretoriaSouth Africa
  10. 10.Cairo University HospitalsCairoEgypt
  11. 11.Cairo UniversityGizaEgypt
  12. 12.King Faisal Specialist Hospital and Research Center—JeddahRiyadhKingdom of Saudi Arabia
  13. 13.Hamad Medical CorporationDohaQatar
  14. 14.Faculté de Médecine et de Pharmacie de MarrakechUniversité Cadi AyyadSidi AbbadMorocco
  15. 15.Department of MedicineMubarak Al-Kabir HospitalKuwait CityKuwait
  16. 16.Service Rhumatologie, Hôpital Ben Aknoun, EHS Appareil LocomoteurAlgerAlgéria
  17. 17.EPS La RabtaTunisTunisia
  18. 18.King Abdul Aziz Medical City, King Fahad National Guard HospitalRiyadhSaudi Arabia
  19. 19.EppsteinGermany
  20. 20.American University of Beirut Medical CenterBeirutLebanon
  21. 21.Hôpital Mongi SlimUniversity of Tunis El ManarLa MarsaTunisia
  22. 22.Rheumatology Department, Kasr El-Aini HospitalsCairo UniversityCairoEgypt
  23. 23.Health Sciences SchoolUniversidad Camilo José CelaMadridSpain
  24. 24.UPRES-EA 4058, APHP, Cochin HospitalParis-Descartes UniversityParisFrance

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