TABLE 2.
Adverse events (AEs) summarized from controlled studies.
| Author | Immunomodulator | AEs (percentages) |
|---|---|---|
| Salvarani et al. (2021) | Tocilizumab | Control group: 2 severe infections; treatment group: 1 upper gastrointestinal tract bleeding. The most common adverse events were increased alanine aminotransferase level and decreased neutrophil count |
| REMAP-CAP Investigators et al. (2021) | Tocilizumab, sarilumab | Treatment group: 1 secondary bacterial infection, 5 bleeding events, 2 cardiac events, 1 deterioration in vision. Control group: 4 bleeding events, 7 thromboses |
| Canziani et al. (2020) | Tocilizumab | Thrombosis: treatment group (19%), control group (17%). Bleeding: treatment group (17%), control group (13%). Infection: treatment group (31%), control group (39) |
| Fisher et al. (2021) | Tocilizumab | No observed increased risk of secondary infection within 14 days of treatment with tocilizumab |
| Campochiaroa et al. (2020) | Tocilizumab | Pulmonary thrombosis: treatment group (6%), control group (9%). Raised ALT, AST level: treatment group (15%), control group (18%). Neutropenia: treatment group (16%), control group (0) |
| Vazquez Guillamet et al. (2021) | Tocilizumab | Culture-negative sepsis: treatment group (41.7%), control group (19.4) |
| Rajendram et al. (2021) | Tocilizumab | Secondary infection: treatment group (25.6%), control group (25.6%) |
| Huang et al. (2021) | Tocilizumab | Secondary infection: treatment group (31%), control group (17%) |
| Saffo et al. (2021) | Tocilizumab | Bleeding: treatment group (24.1%), control group (14.5%). Blood stream infection: treatment group (7.4%), control group (9.2%). Pulmonary infection (endotracheal aspirates/sputum): treatment group (25.9%), control group (30.3%) |
| Somers et al. (2021) | Tocilizumab | Superinfection: treatment group (54%), control group (26%). Bloodstream infection: treatment group (14%), control group (9%). Pneumonia: treatment group (45%), control group (20%) |
| Brosnahan et al. (2021) | Tocilizumab | Positive blood culture: combination group (steroid + tocilizumab) (11.6%), steroid group (12.7%). Positive Fungitell test: combination group (6.9%), steroid group (10.4%). Positive T2Candida panels: combination group (6.4%), steroids group (6.9%). Cytomegalovirus viral loads elevated: combination group (3.5%), steroids group 4.6% |
| Lescure et al. (2021) | Sarilumab | Serious infection: treatment group (12%), control group (12%). ALT increase: treatment group (31.02%), control group (19%). Invasive bacterial or fungal infection: treatment group (6.9%), control group (4%). Grade ≥2 hypersensitivity reaction: treatment group (2.4%), control group (0%). Grade 4 neutropenia: treatment group (2.7%), control group (0) |
| Della-Torre et al. (2020) | Sarilumab | Infections: treatment group (21%), control group (18%). Neutropenia: treatment group (14%), control group (0). Increase in liver enzymes: treatment group (14%), control group (0). Thromboembolism: treatment group (7%), control group (7%) |
| Kyriazopoulou et al. (2021a) | Anakinra | Infections and infestations: treatment group (8.4%), control group (15.9%). Anemia: treatment group (14.3%), control group (19.6%). Increase of liver function tests: treatment group (35.8%), control group (33.3%). Hyperglycemia: treatment group (36.5%), control group (40.2%). Hyponatremia: treatment group (7.9%), control group (12.2%). Hypernatremia: treatment group (11.4%), control group (9%) |
| Bozzi et al. (2021) | Anakinra | Treatment group: grade ≥3 GGT increase (27.7%), anemia (24.6%), ALT increase (6.2%), granulocytopenia (1.5%). Control group: a comparable proportion of these AEs |
| Franzetti et al. (2021) | Anakinra | Bloodstream infections: treatment group (16%), control group (7.1%). Urinary tract infections: treatment group (3.5%), control group (1.8%). Pneumonia infections: treatment group (7.1%), control group (7.1%) |
| Kyriazopoulou et al. (2021b) | Anakinra | Electrolyte abnormalities: treatment group (26.9%), control group (31.5%). Elevated liver function tests: treatment group (30.8%), control group (39.2%). Gastrointestinal disturbances: treatment group (11.5%), control group (6.9%). Anemia: treatment group (16.9%), control group (20%) |
| Cremer et al. (2021) | Mavrilimumab | Bacterial pneumonia: treatment group (10%), control group (5%). SAEs: treatment group (24%), control group (21%). Circulatory shock: treatment group (10%); control group (5%); Acute kidney injury: treatment group (19%), control group (16%). ALT ≥3ULN: treatment group (24%), control group (16%). AST ≥3ULN: treatment group (29%), control group (21%) |
| De Luca et al. (2020) | Mavrilimumab | Infectious complications: treatment group (0), control group (12%) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; ULN, upper limit of normal.