Title:Randomized Clinical Trials on the Efficacy and Safety of Tocilizumab in
Subjects with Rheumatoid Arthritis: A Systematic Review
Volume: 18
Issue: 1
Author(s): Adel Sadeq, Asim Ahmed Elnour*, Azza Ramadan, Israa Yousif Kidir, Judit Don, Abdulla Al Amoodi, Nadia Al Mazrouei, Mohamed A. Baraka, Farah Hamad Farah and Maisoun Alkaabi
Affiliation:
- Program of Clinical Pharmacy,
College of Pharmacy, Abu Dhabi Campus-Al Ain University, Abu Dhabi, UAE
Keywords:
Rheumatoid Arthritis (RA), Interleukin-6 inhibitor (IL-6), Tocilizumab (TCZ), randomized clinical trials, placebo, comparator, safety, efficacy.
Abstract:
Background: The current therapy of Rheumatoid Arthritis (RA) is confronted with many
challenges such as inadequate response, infection, and treatment failure.
Aim and Objective: The main objective was to assess the efficacy and safety of tocilizumab (TCZ) in
subjects with RA using the available evidence from published randomized controlled trials.
Methods: The current systematic review was performed on nine randomized controlled trials from 2002
to 2016 for TCZ in subjects with rheumatoid arthritis. The primary outcomes were the clinical improvement
in American College Rheumatology 20% (ACR20) or Disease Activity Score remission (DAS28),
in addition to other outcomes such as ACR50 and ACR70 in the intention-to-treat population.
Results: We have conducted a systematic review on nine randomized controlled trials, with 4129
[100%] enrolled, of which 3248 [78.7%] were on the intention-to-treat. 2147 (66.1%) were treated
with TCZ and 1101 (33.9%) have had received placebo or methotrexate or other conventional Disease-
Modifying Anti-rheumatic Drugs (cDMARD) or biologic Disease-Modifying Anti-rheumatic
Drugs (bDMARDs). In subjects taking TCZ with or without concomitant methotrexate, compared to
placebo, subjects treated with TCZ 4 or 8 mg/kg were substantially and statistically significantly more
likely than placebo or methotrexate to achieve the ACR20 and/or DAS28. There were no statistically
significant differences in serious adverse events such as serious infection; however, subjects on TCZ
were more likely to have increased lipid profiles.
Conclusion: TCZ mono-therapy or in combination with methotrexate is valuable in diminishing
rheumatoid arthritis disease activity and improving disability. Treatment with TCZ was associated
with a significant surge in cholesterol levels but no serious adverse effects. Randomized clinical trials
with safety as the primary outcome are warranted to report these safety issues.
