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

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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.

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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.

Author information

Authors and Affiliations

  1. University Mohammed Vth Souissi, Rabat, Morocco

    Najia Hajjaj-Hassouni

  2. El Ayachi Hospital, Salé, Morocco

    Najia Hajjaj-Hassouni

  3. Security Force Hospital, Riyadh, Saudi Arabia

    Marzooq Al-Badi

  4. King Hussein Medical Center, Royal Medical Services, Amman, Jordan

    Ala’ Al-Heresh

  5. Weill Cornell Medical School, Doha, Qatar

    Samar Al-Emadi

  6. Riyadh Military Hospital, Riyadh, Saudi Arabia

    Ramiz Alswailem

  7. Mafraq Hospital, PO Box 2951, Abu Dhabi, United Arab Emirates

    Mustafa Al Maaini

  8. Tripoli Medical Center, PO Box 83338, Tripoli, Libya

    Ahmed El Bawendi

  9. Jakaranda Hospital, Pretoria, South Africa

    Elsa van Duuren

  10. Cairo University Hospitals, Cairo, Egypt

    Ayman El Garf

  11. Cairo University, Giza, Egypt

    Khaled El Hadidi

  12. King Faisal Specialist Hospital and Research Center—Jeddah, Riyadh, Kingdom of Saudi Arabia

    Hussein Halabi

  13. Hamad Medical Corporation, Doha, Qatar

    Mohammed Hammoudeh

  14. Faculté de Médecine et de Pharmacie de Marrakech, Université Cadi Ayyad, Sidi Abbad, 40000, Morocco

    Selma El Hassani

  15. Department of Medicine, Mubarak Al-Kabir Hospital, Kuwait City, Kuwait

    Ibrahim Nahar

  16. Service Rhumatologie, Hôpital Ben Aknoun, EHS Appareil Locomoteur, Route des 2 Bassins, Alger, Algéria

    Aïcha Ladjouze Rezig

  17. EPS La Rabta, Tunis, Tunisia

    Slaheddine Sellami

  18. King Abdul Aziz Medical City, King Fahad National Guard Hospital, Riyadh, 11426, PO Box 22490/MC 1510, Saudi Arabia

    Wafaa Sweiri

  19. Bergstrasse 15, Eppstein, Germany, 65817

    Beverly Traub

  20. American University of Beirut Medical Center, PO Box 11-0236, Beirut, 1107 2020, Lebanon

    Imad Uthman

  21. Hôpital Mongi Slim, University of Tunis El Manar, 2046, La Marsa, Tunisia

    Leith Zakraoui

  22. Rheumatology Department, Kasr El-Aini Hospitals, Cairo University, Manial, Cairo, Egypt, 11451

    Bassel El Zorkany

  23. Health Sciences School, Universidad Camilo José Cela, Calle Castillo de Alarcón, 49-Urb, Villafranca del Castillo, 28692, Madrid, Spain

    Loreto Carmona

  24. UPRES-EA 4058, APHP, Cochin Hospital, Paris-Descartes University, Rheumatology B Dpt, Paris, 14, France

    Maxime Dougados

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  1. Najia Hajjaj-Hassouni
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  2. Marzooq Al-Badi
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  3. Ala’ Al-Heresh
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  4. Samar Al-Emadi
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  5. Ahmed El Bawendi
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  6. Ayman El Garf
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  7. Khaled El Hadidi
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  8. Hussein Halabi
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  9. Mohammed Hammoudeh
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  13. Aïcha Ladjouze Rezig
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  14. Slaheddine Sellami
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  15. Wafaa Sweiri
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  17. Beverly Traub
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  18. Imad Uthman
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  19. Elsa van Duuren
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  20. Leith Zakraoui
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  21. Bassel El Zorkany
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  22. Loreto Carmona
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  23. Maxime Dougados
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Correspondence to Najia Hajjaj-Hassouni.

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Hajjaj-Hassouni, N., Al-Badi, M., Al-Heresh, A. et al. The practical value of biologics registries in Africa and Middle East: challenges and opportunities. Clin Rheumatol 31, 407–416 (2012). https://doi.org/10.1007/s10067-011-1918-8

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  • DOI: https://doi.org/10.1007/s10067-011-1918-8

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