The practical value of biologics registries in Africa and Middle East: challenges and opportunities.
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.
University Mohammed Vth Souissi, Rabat, Morocco. nhajjajhassouni@gmail.com
Najia
N
Hajjaj-Hassouni
Marzooq
M
Al-Badi
Ala'
A
Al-Heresh
Samar
S
Al-Emadi
Ahmed
A
El Bawendi
Ayman
A
El Garf
Khaled
K
El Hadidi
Hussein
H
Halabi
Mohammed
M
Hammoudeh
Selma
S
El Hassani
Mustafa
M
Al Maaini
Ibrahim
I
Nahar
Aïcha
A
Ladjouze Rezig
Slaheddine
S
Sellami
Wafaa
W
Sweiri
Ramiz
R
Alswailem
Beverly
B
Traub
Imad
I
Uthman
Elsa
E
van Duuren
Leith
L
Zakraoui
Bassel
B
El Zorkany
Loreto
L
Carmona
Maxime
M
Dougados
D000349:Africa; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D006801:Humans; D008877:Middle East; D012042:Registries; D012216:Rheumatic Diseases / Q000188:drug therapy*
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents