Table 5

Safety analysis of the CareRA trial

COBRA ClassicCOBRA Slim (high risk)COBRA Avant GardeMTX-TSUCOBRA Slim (low risk)Total
Number of patients9898934743379
Total number of AEs3943534521501501499
Total number of AEs related to therapy1841311755451595
 GI tract-related AEs4548672015195
 General malaise-related AEs5222301112127
 Liver function abnormalities1717*226365
 Hair loss710163541
 Infection/inflammation-related AEs11†8772*35
 Changed appetite-related AEs1839434
 GC-related AEs95721
 Blood level-related AEs73*42*16
 Itch and rash4313213
 Diabetes-related AEs212*16
 Visual impairment-related AEs1124
 Kidney function abnormalities123
Serious AEs1515107754
Serious AEs related to therapy*222028
  • Total number of AEs (related to therapy) include serious AEs (related to therapy).

  • *One serious AE related to therapy.

  • †Two serious AEs related to therapy. Online supplementary material 3 gives detailed information per type of AE related to therapy.

  • AE, adverse event; GC, glucocorticoid; GI, gastrointestinal; MTX, methotrexate; TSU, tight step-up.