Table 1.
Selected phase III trials of golimumab that were important to indications approval
| Study | Acronym | Disease | Study arms | Patients randomized (n) | Primary Endpoint/ efficacy |
Safety issues |
|---|---|---|---|---|---|---|
| Emery P, et al26 | GO-BEFORE | RA | Placebo +MTX (group 1), GOL100 mg +placebo (group 2), GOL 50 mg +MTX (group 3), GOL 100 mg+MTX (group 4) | 637 | Not achieved. Week 24: ACR50 showed no differences; DAS28 response and DAS28 remission in the groups 3 + 4 vs group 1 were significant |
At week 24, 72.5%, 68.2%, 81.6% and 76.1% of patients reported AE in groups 1,2,3 and 4, respectively. SAE were reported in 6.9%, 3.2%, 6.3% and 6.3% in the same groups. |
| Keystone EC, et al27 | GO- FORWARD |
RA | Placebo +MTX (group 1), GOL 100 mg +placebo (group 2), GOL 50 mg +MTX (group 3), GOL 100 mg +MTX (group 4) | 444 | Achieved; Week 14: ACR20 was statistically superior in the groups 3 and 4 vs group 1 |
During the placebo-controlled phase of the study, 60.9%, 63.2%, 68.5% and 69.7% of patients reported AE in groups 1,2,3 and 4, respectively. After early scape, SAE reported in group 4 was 12.4% vs 3.7%, 6% and 4.2% in groups 1, 2 and 3 |
| Smolen J, et al28 | GO-AFTER | RA | Placebo, GOL 50 mg, GOL 100 mg | 461 | Achieved; Week 14: ACR20 was statistically higher in the GOL groups vs placebo |
Weeks 1–16: AE were recorded in 70% patients on placebo, 61% on 50 mg GOL, and 73% on 100 mg GOL. Weeks 1–24, SAE were recorded in 10% of patients on placebo, 5% on 50 mg GOL, and 4% on 100 mg GOL. |
| Kavanaugh A, et al30 | GO-REVEAL | PsA | Placebo, GOL 50 mg, GOL100 mg | 405 | Achieved; Week 14: ACR20 in the GOL groups was statistically superior than that of group placebo |
Weeks 1–16, AE were recorded in 59% patients on placebo, 68% on 50 mg GOL and 65% on 100 mg GOL. Weeks 1–24, SAE were recorded in 6% patients on placebo, 2% on 50 mg GOL, and 3% on 100 mg GOL. |
| Kavanaugh A, et al42 | GO-VIBRANT | PsA | Placebo, IV GOL at 2 mg/kg |
480 | Achieved; Week 14: ACR20 in the GOL group was statistically superior than that of group placebo |
week 24: AE were reported in 46.3% of patients in the GOL group (of which 2.9% were SAE) vs 40.6% in the placebo group (of which 3.3% were SAE) |
| Inman R. et al29 | GO-RAISE | SpA | Placebo, GOL 50 mg, GOL 100 mg | 356 | Achieved; Week 14: ASAS20 in the GOL groups was statistically superior than that of group placebo |
week 24:AE reported in 85.6% of patients in the GOL group (of which 5.4% were SAE) vs 76.6% in the placebo group (of which 6.5% were SAE) |
| Sieper J. et al44 | - | nr- axSpA |
Placebo, GOL 50 mg | 198 | Achieved; Week 16: ASAS20 in the GOL group was statistically superior than that of group placebo |
week 16:AE reported in 41.2% of patients in the GOL group (of which 1% were SAE) vs 47% in the placebo group (of which 2% were SAE) |
| Brunner H. et al45 | GO-KIDS | JIA | Part 1 GOL (30 mg/m2; maximum: 50 mg/dose) and MTX Part 2: GOL or placebo; Part 3: GOL continued or restarted as in Part 1. |
173 | Not achieved; Part 2: treatment groups had comparable JIA flare rates; After Part 1, JIA ACR30 was achieved by 89.0% of patients |
During Part 2, AE were reported in 78.2%of patients in the GOL group (of which 10.3% were SAE) vs 82.9% in the placebo group (of which 13.2% were SAE) |
| Sandborn, WJ et al32 | PURSUIT–SC* | UC | Phase 2: Placebo, GOL100/50 mg, 200/100 mg, 400/200 mg Phase 3: Placebo, GOL 200/100 mg, 400/200 mg |
1065 | Achieved; Week 6: more patients in the treatment groups achieved clinical response compared with the placebo arm |
AE reported in 37.5%, 38.9%, and 38.2% for the 200/100 mg GOL 400/200 mg GOL and placebo arms, respectively. SAE reported by 3% of GOL-treated and 6.1% of placebo-treated patients. |
| Rutgeerts P. et al43 | PURSUIT–IV* | UC | Phase 2: placebo, GOL 1 mg/kg, GOL 2 mg/kg, GOL 4 mg/kg Phase 3: placebo, GOL 2 mg/kg,GOL 4 mg/kg |
291 | Not achieved; Efficacy with golimumab IV induction was lower than expected |
Week 6: AE reported in 36.6% of GOL treated patients and 31.2% of patients given placebo; SAE were reported in 3.8% and 2.6%, respectively |
| Sandborn, WJ et al33 | PURSUIT–M | UC | Placebo, GOL50 mg, GOL100 mg | 464 | Achieved; Week 54: the proportions of patients who maintained a clinical response was significantly greater in GOL compared with the placebo group |
Week 54: AE were reported in 66% given placebo (of which 7.7% were SAE), 72.7%, given 50 mg GOL (of which 8.4% were SAE) and 73.4% given 100 mg GOL (of which 14.3% were SAE) |
* Phase 2/3 induction study
Note: Golimumab: GOL; RA: Rheumatoid Arthritis; PsA: Psoriatic Arthritis; AS: Ankylosing Spondylitis; nr-axSpA: Nonradiographic axial Spondyloarthritis; JIA: Juvenile Idiopathic Arthritis; UC: Ulcerative Colitis; Adverse events: AE; SAE: serious adverse events; ACR20: at least 20% improvement in the American College of Rheumatology criteria; ASAS20: at least 20% improvement in the Assessment in AS