Will Tremfya (guselkumab) cause frequent upper respiratory tract infections?

Tremfya and Upper Respiratory Infections

Tremfya (guselkumab) does cause a modest increase in upper respiratory tract infections compared to placebo, but the overall infection risk is low and not considered "frequent" in clinical practice. The FDA label specifically notes that upper respiratory tract infections occurred more frequently in the Tremfya group than placebo, though the absolute difference is small 1.

Infection Risk Profile

According to the FDA drug label, in clinical trials for plaque psoriasis:

• Overall infections occurred in 23% of Tremfya patients versus 21% of placebo patients through 16 weeks 1
• Upper respiratory tract infections specifically were among the infections that occurred more frequently with Tremfya than placebo 1
• The rate of serious infections remained very low at ≤0.2% in both groups 1

Real-World Evidence

The most comprehensive long-term safety analysis pooling seven clinical trials with over 8,600 patient-years of exposure confirms this favorable profile:

• Infection rates with guselkumab were 95.9 per 100 patient-years versus 83.6 per 100 patient-years with placebo during the controlled period 2
• Through up to 5 years of follow-up, the infection rate decreased to 65.9 per 100 patient-years 2
• No opportunistic infections or active tuberculosis occurred related to guselkumab 2

Real-world community practice data shows nasopharyngitis and upper respiratory tract infections as the most commonly reported side effects, but these were generally mild and did not lead to treatment discontinuation 3.

Clinical Context

The increased infection risk is clinically manageable:

• Most infections are mild upper respiratory infections (nasopharyngitis, common colds)
• Recent pediatric data showed nasopharyngitis and upper respiratory tract infections as common adverse events, but no serious or opportunistic infections occurred 4
• In ulcerative colitis trials, the safety profile remained consistent with no new infection signals 5

Key Precautions

Do not initiate Tremfya if:

• Patient has any clinically important active infection until it resolves 1
• Patient has active tuberculosis 1

Exercise caution in:

• Patients with chronic infection or history of recurrent infections—weigh risks versus benefits before prescribing 1
• Patients with pre-existing immunosuppression-related conditions 6

Monitoring requirements:

• Screen for tuberculosis before initiating treatment 1
• Instruct patients to seek medical help if signs of clinically important infection develop 1
• If serious infection develops, monitor closely and discontinue Tremfya until infection resolves 1

Bottom Line

While upper respiratory infections do occur slightly more often with Tremfya than placebo, the absolute increase is modest and these infections are typically mild. The term "frequent" would be misleading—serious infections remain rare at ≤0.2%, and the overall safety profile through 5 years of data is favorable 2. The AAD-NPF guidelines note that IL-23 inhibitors like guselkumab should be used with caution in immunosuppressed patients, but do not identify upper respiratory infections as a major limiting factor 6.