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. 2011 Feb 16;2011(2):CD008794.
doi: 10.1002/14651858.CD008794.pub2.

Adverse effects of biologics: a network meta-analysis and Cochrane overview

Jasvinder A Singh  1 , George A Wells, Robin Christensen, Elizabeth Tanjong Ghogomu, Lara Maxwell, John K Macdonald, Graziella Filippini, Nicole Skoetz, Damian Francis, Luciane C Lopes, Gordon H Guyatt, Jochen Schmitt, Loredana La Mantia, Tobias Weberschock, Juliana F Roos, Hendrik Siebert, Sarah Hershan, Michael Pt Lunn, Peter Tugwell, Rachelle Buchbinder
Affiliations

Adverse effects of biologics: a network meta-analysis and Cochrane overview

Jasvinder A Singh et al. Cochrane Database Syst Rev. .

Abstract

Background: Biologics are used for the treatment of rheumatoid arthritis and many other conditions. While the efficacy of biologics has been established, there is uncertainty regarding the adverse effects of this treatment. Since serious risks such as tuberculosis (TB) reactivation, serious infections, and lymphomas may be common to the biologics but occur in small numbers across the various indications, we planned to combine the results from biologics used in many conditions to obtain the much needed risk estimates.

Objectives: To compare the adverse effects of tumor necrosis factor blocker (etanercept, adalimumab, infliximab, golimumab, certolizumab), interleukin (IL)-1 antagonist (anakinra), IL-6 antagonist (tocilizumab), anti-CD28 (abatacept), and anti-B cell (rituximab) therapy in patients with any disease condition except human immunodeficiency disease (HIV/AIDS).

Methods: Randomized controlled trials (RCTs), controlled clinical trials (CCTs) and open-label extension (OLE) studies that studied one of the nine biologics for use in any indication (with the exception of HIV/AIDS) and that reported our pre-specified adverse outcomes were considered for inclusion. We searched The Cochrane Library, MEDLINE, and EMBASE (to January 2010). Identifying search results and data extraction were performed independently and in duplicate. For the network meta-analysis, we performed mixed-effects logistic regression using an arm-based, random-effects model within an empirical Bayes framework.

Main results: We included 163 RCTs with 50,010 participants and 46 extension studies with 11,954 participants. The median duration of RCTs was six months and 13 months for OLEs. Data were limited for tuberculosis (TB) reactivation, lymphoma, and congestive heart failure. Adjusted for dose, biologics as a group were associated with a statistically significant higher rate of total adverse events (odds ratio (OR) 1.19, 95% CI 1.09 to 1.30; number needed to treat to harm (NNTH) = 30, 95% CI 21 to 60) and withdrawals due to adverse events (OR 1.32, 95% CI 1.06 to 1.64; NNTH = 37, 95% CI 19 to 190) and an increased risk of TB reactivation (OR 4.68, 95% CI 1.18 to 18.60; NNTH = 681, 95% CI 143 to 14706) compared to control.The rate of serious adverse events, serious infections, lymphoma, and congestive heart failure were not statistically significantly different between biologics and control treatment. Certolizumab pegol was associated with significantly higher risk of serious infections compared to control treatment (OR 3.51, 95% CI 1.59 to 7.79; NNTH = 17, 95% CI 7 to 68). Infliximab was associated with significantly higher risk of withdrawals due to adverse events compared to control (OR 2.04, 95% CI 1.43 to 2.91; NNTH = 12, 95% CI 8 to 28). Indirect comparisons revealed that abatacept and anakinra were associated with a significantly lower risk of serious adverse events compared to most other biologics. Although the overall numbers are relatively small, certolizumab pegol was associated with significantly higher odds of serious infections compared to etanercept, adalimumab, abatacept, anakinra, golimumab, infliximab, and rituximab; abatacept was significantly less likely than infliximab and tocilizumab to be associated with serious infections. Abatacept, adalimumab, etanercept and golimumab were significantly less likely than infliximab to result in withdrawals due to adverse events.

Authors' conclusions: Overall, in the short term biologics were associated with significantly higher rates of total adverse events, withdrawals due to adverse events and TB reactivation. Some biologics had a statistically higher association with certain adverse outcomes compared to control, but there was no consistency across the outcomes so caution is needed in interpreting these results.There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics. National and international registries and other types of large databases are relevant sources for providing complementary evidence regarding the short- and longer-term safety of biologics.

PubMed Disclaimer

Conflict of interest statement

JS: speaker honoraria from Abbott; research grants from AMGEN, Allergan, Takeda, Savient; consultant fee from Savient, URL Pharma, Novartis and Takeda.

GW: research grant and consultant fee from Bristol‐Myers Squibb; consultant fees from Abbott, Amgen, UCB; Data Safety Monitoring for Novartis.

RC: has received consulting fees, honoraria, research or institutional support, educational grants, equipment, services or expenses from: Abbott, Astellas Pharma, Axellus, Bristol‐Myers Squibb, Cambridge Nutritional Foods, Centocor, DSM Nutritional Products, Hypo‐Safe, MSD, MundiPharma, NorPharma, Pharmavie, Pfizer, Roche, Sanofi‐Aventis, Scandinavian Clinical Nutrition.

ETG: none

NS: none

JKM: none

Filippini: none

DF: none

Lopes: none

La Mantia: none

Guyatt: in the last 5 years, Dr Guyatt has received grant funding from Pfizer, Lotte and John Hecht Foundation, Bristol‐Myers‐Squibb, and Astra Zeneca. Dr Guyatt has also received consultation fee from Up‐To‐Date and Eli Lilly Canada. To our knowledge, none of these are conflicted with the subject matter of this submission.

Lunn: honoraria from Baxter in relation to advisory boards on the use of IVIG.

LM: none

Schmitt: research grant from Wyeth.

PT: grants/honoraria from Bristol Myers, Chiltern International, and UCB

RB: honoraria for the 3e initiative in 2010 funded by Abbott; Principal Investigator for the Australian Rheumatology Association Database (ARAD) ‐ The Australian Rheumatology Association has received unrestricted educational grants from Abbott, Amgen, Roche and Wyeth for ARAD.

JR: none

SH: none

TW: none

HS: none

RJ: none

CC: none

Figures

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Flow diagram.
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Forest plot of network meta‐analysis: total adverse events
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3
Forest plot of network meta‐analysis: withdrawals due to adverse events
4
4
Forest plot of network meta‐analysis: serious infections
5
5
Forest plot of network meta‐analysis: serious adverse events
6
6
Forest plots of standard meta‐analyses
See this image and copyright information in PMC

Update of

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Tyring 2006
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Van der Heijde 2006c
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Van der Heijde 2008b
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