Is golimumab (Tumor Necrosis Factor-alpha (TNF-alpha) inhibitor) safer than infliximab (chimeric monoclonal antibody) and adalimumab (human monoclonal antibody)?

Safety Comparison of TNF-Alpha Inhibitors

Based on current evidence, golimumab does not demonstrate superior safety compared to infliximab or adalimumab, and the choice between these agents should be guided primarily by efficacy data and specific clinical contexts rather than safety profiles alone. 1

Overall Safety Profile

The available evidence does not establish clear safety advantages of one TNF-alpha inhibitor over another:

• Vedolizumab and anti-IL therapies may be associated with lower rates of infectious complications than TNF antagonists (including all three agents: golimumab, infliximab, and adalimumab), making them preferred in patients at higher risk of immunosuppression-related infections or malignancies 1

• When all anti-TNF agents were pooled against placebo in ankylosing spondylitis trials, there was a small absolute increase in withdrawals due to adverse events (1%; 95% CI 0% to 2%), but no conclusive evidence of increased serious adverse events, though event rates were low 2

• Regulatory agencies have published warnings about rare adverse events across the entire TNF-inhibitor class, including serious infections (particularly tuberculosis), malignancies, and lymphoma 2

Specific Safety Considerations by Agent

Golimumab-Specific Concerns

• Golimumab showed higher rates of myelosuppression and acromegaly in WHO adverse drug reaction reports compared to other TNF inhibitors 3

• Lower respiratory tract infections and other infections had the highest ADR report ratio for golimumab among the five TNF inhibitors analyzed 3

• In indirect comparisons, serious adverse events were significantly more frequent with golimumab 100 mg maintenance dose compared to infliximab (p < 0.05) 4

Infliximab-Specific Concerns

• Infliximab showed a significantly higher ADR report ratio for infusion-related reactions compared to the other four TNF inhibitors 3

• This is clinically relevant as infliximab requires intravenous administration, creating additional monitoring requirements and potential acute reactions 3

Adalimumab Safety Profile

• Adalimumab demonstrated comparable safety to other TNF inhibitors in pooled analyses, with no specific safety signals distinguishing it from infliximab or golimumab 2, 3

Context-Specific Safety Recommendations

For Patients with Ulcerative Colitis

• The 2024 AGA guidelines note that vedolizumab and anti-IL therapies may be preferred over any TNF antagonist (including golimumab, infliximab, or adalimumab) in patients at higher risk of infections or malignancies 1

• Network meta-analyses present conflicting data on comparative efficacy but do not establish safety differences between infliximab, adalimumab, and golimumab 1

For Patients with Ankylosing Spondylitis and Comorbidities

• In patients with recurrent uveitis, adalimumab or infliximab are preferred over etanercept, with golimumab also considered though supporting data are less substantial 1

• In patients with inflammatory bowel disease, infliximab, adalimumab, and golimumab are all approved, while etanercept is not, suggesting a class effect for these three agents 1

Common Pitfalls to Avoid

• Do not assume subcutaneous administration (adalimumab, golimumab) is inherently safer than intravenous administration (infliximab) - while infliximab has higher infusion-related reactions, golimumab has higher infection rates 3, 4

• Do not overlook the increased infection risk with golimumab specifically - this agent showed the highest rates of respiratory infections in post-marketing surveillance 3

• Do not ignore the potential for serious adverse events requiring monitoring across all three agents, including tuberculosis screening, hepatitis B screening, and malignancy surveillance 2

• Avoid selecting based solely on route of administration - the safety profile differences are more nuanced than simply IV versus subcutaneous delivery 3

Practical Clinical Approach

When safety is the primary concern:

• Consider vedolizumab or anti-IL therapies first in patients with high infection risk, cardiovascular risk factors, or prior malignancy 1

• Among TNF inhibitors, infliximab may have a slight edge in efficacy (particularly in ulcerative colitis), but this comes with higher infusion-related reactions 1, 4

• Golimumab should be used cautiously in patients with recurrent infections given the higher ADR reporting rates for respiratory infections 3

• Adalimumab represents a middle ground with no specific safety signals distinguishing it positively or negatively from the other two agents 2, 3