Table 2

Treatment-related adverse events

Author, yearTherapyAdverse effects
Balkhair et al, 202026AnakinraTreatment: infection (11%), ALT rise (14%). Control: infection (18%), ALT rise (9%)
Huet et al, 202029AnakinraTreatment: ALT rise (13%). Control: 9% in anakinra
Kooistra et al, 202035AnakinraTreatment: secondary infection (33%). Control: secondary infection (23%)
*Kyriazopoulou et al, 202028AnakinraIncreased leucopenia in treatment group versus controls (8.5% vs 2.3%; p=0.05)
Cauchois et al, 202024AnakinraN/R
Cavalli et al, 202025AnakinraTreatment: Staphylococcus epidermis (14%), deranged liver enzymes (10%). Control: bacteraemia (13%), deranged liver enzymes (31%)
Narain et al, 202027AnakinraN/R
Benucci et al, 202044SarilumabNil
Della-Torre et al, 202030SarilumabTreatment: infections (21%), neutropenia (14%), liver enzyme increase (14%), thromboembolism (7%). Control: infections (18%), thromboembolism (7%)
*Gordon et al, 202120SarilumabNo serious event in sarilumab group and 11 events in control
Gremese et al, 202051SarilumabNeutropenia (15%), elevated liver enzymes (11%)
Sinha et al, 202054Sarilumab or tocilizumabBacterial infection (13%)
*Gritti et al, 202031SiltuximabNil
Albertini et al, 202059TocilizumabElevated liver enzymes (64%)
Antony et al, 202062TocilizumabN/R
Campins et al, 202065TocilizumabNil
*Carvalho et al, 202068TocilizumabNil
Chilimuri et al, 202055TocilizumabN/R
Dastan et al, 202071TocilizumabTransient diplopia (4.8%), Bell’s palsy (2.4%)
*Gordon et al, 202120Tocilizumab9 serious adverse events in tocilizumab group and 11 events in control
Hermine et al, 202023TocilizumabTreatment: serious adverse events occurred in 20 (32%). Control: 29 (43%) (p=0.21)
Lewis et al, 202037TocilizumabIncreased infection rate in treatment group (aOR 4.18; 95% CI 2.72 to 6.52)
Malekzadeh et al, 202078TocilizumabNil
Mikulska et al, 202081TocilizumabN/R
Morena et al, 202084TocilizumabElevated liver enzymes (29%), thrombocytopenia (14%), neutropenia (6%), infections (24%)
Nasa et al, 202041TocilizumabTwo patients (9.1%) developed deranged LFTs and two patients (9.1%) developed secondary sepsis
Perrone et al, 202087TocilizumabAllergic reactions (0.4%), deranged liver enzymes (10.5%)
*Petrak et al, 202046TocilizumabN/R
*Rosas et al, 202086Tocilizumab66 serious infections (21%) were reported in the treatment arm and 49 (25.9%) in the placebo arm. Adverse events similar in both arms
Roumier et al, 202032TocilizumabTreatment: higher rates of neutropenia (35% vs 0%, p<0.001). Control: trend towards increased bacterial infections (22% vs 38%, p=0.089; including ventilator-acquired pneumonia: 8% vs 26%, p=0.022) and shorter time to infection (mean 18 vs 10 days, p=0.029)
Salama et al, 202022TocilizumabSerious adverse events occurred in 38 of 250 patients (15.2%) in the tocilizumab group and 25 of 127 patients (19.7%) in the placebo group
Salvarani et al, 202036TocilizumabNil
*Sanchez-Montalva et al, 202038TocilizumabNil
Sciascia et al, 202040TocilizumabNil
Stone et al, 202021TocilizumabNeutropenia developed in 22 patients in the treatment group, as compared with only 1 patient in the placebo group (p=0.002), but serious infections occurred in fewer patients in the tocilizumab group (13 (8.1%)vs 14 (17.3%); p=0.03)
Strohbehn et al, 202042TocilizumabTreatment: bacterial infections (15.6%). Control: not reported
Toniati et al, 202045TocilizumabSeptic shock (2%), gastrointestinal perforation (1%)
Biran et al, 202047TocilizumabTreatment: secondary bacterial infection in 17%. Control: secondary bacterial infection in 13%
Canziani et al, 202049TocilizumabHR 0.71 (95% CI 0.38 to 1.32) for infection, HR 0.89 (95% CI 0.39 to 2.06) for thrombosis, HR 1.17 (95% CI 0.47 to 2.92) for bleeding
Capra et al, 202052TocilizumabNil
De Rossi et al, 202057TocilizumabSignificant rise (from 44.3±28.3 to 103±141.3) in ALT in patients taking intravenous dose
Eimer et al, 202060TocilizumabBlood stream infection: 4 (18%) in treatment group versus 6 (27%) in control
Fisher et al, 202063TocilizumabNo increased risk of secondary infection (OR 1.17; 95% CI 0.51 to 2.71)
Galván-Román et al, 202066TocilizumabN/R
*Moreno Garcia et al, 202069TocilizumabN/R
Gokhale et al,202072TocilizumabN/R
Guaraldi et al, 202074Tocilizumab13% treated diagnosed with new infections versus 4% in control (p<0.0001)
Guisado-Vasco et al, 202076TocilizumabN/R
Gupta et al, 202079TocilizumabTreated and control patients experienced the following adverse events: secondary infection (140 (32.3%)vs 1085 (31.1%)), AST or ALT level elevation of more than 250 U/L (72 (16.6%)vs 452 (12.9%))
Hill et al, 202082TocilizumabIn treatment group compared with control group, there was increased sepsis (21%vs16%), ALT rise (9% vs 4%) and thrombocytopenia (12% vs 4%)
Holt et al, 202085TocilizumabN/R
Ip et al, 202088TocilizumabN/R
Kewan et al, 202090TocilizumabSimilar rates of hospital-acquired infections occurred in both cohorts (18% in treatment and 22% in control)
Kimmig et al, 202033TocilizumabTreatment associated with increased secondary bacterial (aOR 2.76; 95% CI 1.11 to 7.2) and fungal (5.6% vs 0%, p=0.112) infections
Klopfenstein et al, 202034TocilizumabN/R
Martinez-Sanz et al, 202039TocilizumabN/R
Narain et al, 202027TocilizumabN/R
Patel et al, 202043TocilizumabN/R
Pettit et al, 202048TocilizumabOverall infection rate was similar (16.2% treatment vs 17.5% control), but late onset infections occurred in more treated patients (23% vs 8%; p=0.013). In treated, 26% experienced an increase to >5 times upper limit normal of LFTs
Potere et al, 202050TocilizumabNil
*Ramaswamy et al, 202053TocilizumabN/R
Rodríguez-Baño et al, 202056TocilizumabSecondary bacterial infection similar in both groups (treated 12.5% vs 10.3% control; p=0.57)
Rojas-Marte et al, 202058TocilizumabBacteraemia was more common in the control group (24% vs 13%, p=0.43), while fungemia was similar for both (3% vs 4%, p=0.72)
Roomi et al, 202061TocilizumabN/R
Rosas et al, 202064TocilizumabNil
Rossi et al, 202067TocilizumabN/R
Rossotti et al, 202070TocilizumabInfectious complication in 32.4%
Ruiz-Antorán et al, 202073Tocilizumab32.6% in treated versus 30.3% in control had increase in liver enzymes. Bacteraemia in one patient (0.4%)
Somers et al, 202075TocilizumabHigher rate of superinfection in treated group (54% vs 26%; p<0.001)
Tian et al, 202077TocilizumabDeranged LFTs in 14% of tocilizumab and 14% of control group
Tsai et al, 202080TocilizumabN/R
*Wadud et al, 202083TocilizumabN/R
Zheng et al, 202086TocilizumabN/R
  • Adverse events for drug under study reported. Adverse events for control population reported where applicable.

  • *Non-peer-reviewed preprint study.

  • ALT, alanine transaminase; aOR, adjusted odds ratio; AST, aspartate transaminase; LFTs, liver function tests; N/R, not reported.