The efficacy of Adalimumab ( Humira ) in children with moderately to severely active Crohn’s disease enrolled in the IMAgINE 1 trial has been reported up to week ( wk ) 52. Long-term efficacy of Adalimumab in patients enrolled in the on-going open-label ( OL ) extension, IMAgINE 2, is presented.
Patients who completed IMAgINE 1 through week 52 were allowed to enroll in IMAgINE 2. Patients entering from blinded therapy received open-label Adalimumab according to body weight ( greater than or equal to 40 kg: 40 mg Adalimumab every other week [ EOW ]; less than 40 kg, 20 mg Adalimumab EOW ).
At or after week 8, patients experiencing flares ( increase in PCDAI greater than or equal to 15 points compared to PCDAI at previous visit ) could move to weekly ( EW ) dosing.
Patients entering IMAgINE 2 from open-label Adalimumab ( 40 mg Adalimumab or 20 mg Adalimumab EW ) continued to receive the same dose.
Remission ( PCDAI less than or equal to 10 ) and response ( PCDAI decrease greater than or equal to 15 points from IMAgINE 1 baseline ) over time were assessed in patients who entered IMAgINE 2.
Of the 188 randomized pts in IMAgINE 1, a total of 100 patients enrolled in IMAgINE 2.
As of Jun 30, 2013, a total of 54 patients are ongoing in the study.
Approximately 2/3 of patients entered IMAgINE 2 in remission and almost all entered with response ( 67% and 95%, respectively ).
Observed remission and response rates remained stable over time during IMAgINE 2.
Mean PCDAI scores decreased from 40.1 at IMAgINE 1 baseline to 8.6 at week 192 of IMAgINE 2.
Adverse event rates from IMAgINE 1 baseline up to week 260 have been previously reported and no new safety signals were observed with prolonged Adalimumab use.
In conclusion, results of the on-going open-label study support clinically meaningful efficacy with long-term Adalimumab therapy beyond four years of exposure in children with moderately to severely active Crohn’s disease. ( Xagena )
Source: UEG ( United European Gastroenterology ) Week, 2014