Treatment of Inflammatory Bowel Disease with Biologics

18

Table 2.1

(continued)

Golimumab

Sandborn et al. [

28

]

Induction with SC golimumab (PURSUIT-SC)

761 patients

Randomized to placebo, 200/100 mg, and 400/200 mg at weeks 0 and 2

Rates of clinical response at week 6 were 30.3%, 51.0%, and 54.9% for placebo, 200/100 mg, and 400/200 mg golimumab groups, respectively (both, P^

≤

 0.0001)

Rates of clinical remission at week 6 were 6.4%, 17.8%, and 17.9% for placebo, 200/100 mg, and 400/200 mg golimumab groups, respectively (both,

P < 0.0001)

Rates of mucosal improvement were 28.7%, 42.3%, and 45.1% for placebo, 200/100 mg, and 400/200 mg golimumab groups, respectively (

P

 = 0.0014,

P < 0.0001,

respectively)

Sandborn et al. [

29

]

Maintenance (PURSUIT-SC maintenance)

464 patients who responded to induction therapy with golimumab

Randomized to placebo, 50 mg, or 100 mg golimumab every 4 weeks

Clinical response maintained through week 54 in 31.2%, 47.0%, and 49.7% and of patients receiving placebo, 50 mg, and 100 mg golimumab, respectively (P

 = 0.010 and

P < 0.001, respectively)

Rates for clinical remission and mucosal improvement at weeks 30 and 54 were 15.6% and 26.6% for placebo, 23.2% and 41.7% for golimumab 50 mg, and 27.8% and 42.4% for golimumab 100 mg (P

 = 0.004, P = 0.002, respectively)

Anti-TNF aClinical response, clinical remission, and mucosal improvement results are all for the ITT-A3 treatment group, which were patients in the amended study protocol

α^

medication

Authors, date

Study summary

Study population, sample size

Dosing information

Clinical response

Clinical remission and mucosal improvement

K. Clark-Snustad et al.