Golimumab for the treatment of ulcerative colitis

Figures & data

Table 1 The dosing interval of antitumor necrosis factor (TNF) agents is determined by several factors, such as half-life, affinity for TNF, and protein stability

Anti-TNF	Administration route	Dosing interval	Half-life (days)
Infliximab	Intravenous	Every 8 weeks	8–9.5
Adalimumab	Subcutaneous	Every 2 weeks	14
Golimumab	Subcutaneous	Every 4 weeks	14

Notes: Golimumab is a stable human monoclonal antibody that can bind with high affinity to TNF, enabling less frequent dosing compared with adalimumab. An advantage of golimumab over infliximab is the fact that it is administered subcutaneously.

Table 2 PURSUIT-SC study results

PURSUIT-SC study	GLM 200/100 mg at weeks 0 and 2 (%)	GLM 400/200 mg at weeks 0 and 2 (%)	Placebo (%)
Clinical response at week 6	51	54.9	30.3
Clinical remission at week 6	17.8	17.9	6.4
Mucosal healing at week 6	42.3	45.1	28.7

Notes: The recent Phase III PURSUIT clinical trials were the pivotal trials that led to regulatory approval of golimumab for ulcerative colitis.

Abbreviations: GLM, golimumab; PURSUIT, Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment.

Table 3 PURSUIT-Maintenance trial results

PURSUIT-Maintenance	GLM 50 mg every 4 weeks (%)	GLM 100 mg every 4 weeks (%)	Placebo (%)
Continuous clinical response through week 54 (among induction responders)	47	49.7	31.2
Clinical remission at weeks 30 and 54	23.2	27.8	15.6
Mucosal healing at weeks 30 and 54	41.7	42.4	26.6

Notes: The recent Phase IIIPURSUIT clinical trials were the pivotal trials that led to regulatory approval of golimumab for ulcerative colitis.

Abbreviations: GLM, golimumab; PURSUIT, Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment.

Table 4 Induction treatment with golimumab consists of two injections: 200 mg and 100 mg at week 0 and week 2, respectively

Body weight <80 kg	Body weight >80 kg
Induction treatment
200 mg at week 0	200 mg at week 0
100 mg at week 2	100 mg at week 2
Maintenance treatment
EMA advises 50 mg every 4 weeks	EMA advises 100 mg every 4 weeks
FDA advises 100 mg every 4 weeks	FDA advises 100 mg every 4 weeks

Abbreviations: EMA, European Medicines Agency; FDA, US Food and Drug Administration.