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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.


Najia Hajjaj-Hassouni, 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. The practical value of biologics registries in Africa and Middle East: challenges and opportunities. Clinical rheumatology. 2012 Mar;31(3):407-16

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PMID: 22228237

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