From the Guidelines
Benlysta (belimumab) can cause several side effects, including nausea, diarrhea, fever, insomnia, headache, depression, pain in extremities, and injection site reactions, with more serious side effects being infections, allergic reactions, depression, suicidal thoughts, and progressive multifocal leukoencephalopathy (PML), as reported in a phase IV RCT (BASE) with 4003 patients 1. The most common side effects of Benlysta include:
- Nausea
- Diarrhea
- Fever
- Insomnia
- Headache
- Depression
- Pain in extremities
- Injection site reactions More serious side effects that require immediate medical attention include:
- Infections (which may appear as fever, cough, or flu-like symptoms)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
- Depression
- Suicidal thoughts
- Progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection According to a pooled post hoc analysis of one phase II and five phase III RCTs of belimumab (total 4170 patients), serious depression was more common with belimumab (0.2% vs 0.1%) although suicide/self-injury was similar (0.3% in each group) 1. Benlysta works by targeting B-lymphocyte stimulator (BLyS), a protein that helps B cells survive, which are involved in the abnormal immune response in lupus. By reducing B cell numbers, Benlysta helps decrease lupus activity, but this same mechanism increases infection risk. Patients should receive all vaccinations before starting treatment and should not receive live vaccines while on Benlysta. Regular monitoring by a healthcare provider is essential to manage potential side effects effectively, as recommended by the 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus 1.
From the FDA Drug Label
What are the possible side effects of BENLYSTA? BENLYSTA can cause serious side effects, including: • Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. • Cancer. BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers The most common side effects of BENLYSTA include: • nausea • diarrhea • fever • stuffy or runny nose and sore throat (nasopharyngitis) • persistent cough (bronchitis) • trouble sleeping (insomnia) • leg or arm pain • depression • headache (migraine) • pain, redness, itching, or swelling at the site of injection (when given subcutaneously)
Benlysta side effects include serious and common adverse reactions. Serious side effects are Progressive Multifocal Leukoencephalopathy (PML) and cancer, as Benlysta may reduce the activity of the immune system. The most common side effects of Benlysta are:
- Gastrointestinal symptoms: nausea, diarrhea, fever
- Respiratory symptoms: stuffy or runny nose and sore throat, persistent cough
- Neurological symptoms: trouble sleeping, leg or arm pain, depression, headache
- Local reactions: pain, redness, itching, or swelling at the site of injection (when given subcutaneously) 2 2 2
From the Research
Benlysta Side Effects
- The most common side effects of Benlysta (belimumab) include infusion reactions, nausea, diarrhea, and fever 3.
- In clinical trials, Benlysta was generally well tolerated, with low rates of immunogenicity 3.
- However, some studies have reported numerical differences in the incidence of mortality and adverse events of special interest (AESIs) 4.
- A meta-analysis of randomized controlled trials found that Benlysta did not increase the risk of adverse events compared to a control treatment 5.
- The most common AESIs reported in clinical trials include:
- A systematic review and meta-analysis found that the risk of serious adverse events, including serious infections and malignancies, was similar between Benlysta and placebo groups 6.
- Another study found that the pharmacokinetics of subcutaneous Benlysta were comparable to those of intravenous Benlysta, with similar exposure profiles and no requirement for a loading dose 7.
Specific Side Effects
- Infusion reactions: reported in 0.4% of patients in the Benlysta group versus 0.1% in the placebo group 4.
- Hypersensitivity reactions: reported in 0.4% of patients in the Benlysta group versus 0.1% in the placebo group 4.
- Serious infections: reported in 3.75% of patients in the Benlysta group versus 4.10% in the placebo group 4.
- Depression: reported in 1.42% of patients in the Benlysta group versus 1.16% in the placebo group 4.
- Suicidality: reported in 1.42% of patients in the Benlysta group versus 1.16% in the placebo group 4.