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Label indication SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1 ) adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2 ) adult patients with active ankylosing spondylitis (AS) ( 1.3 ) adult and pediatric patients weighing at least 15 kg… FDA label
Also known as SC golimumab, Simponi®
golimumab · 2 trials · 2 indications
The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of \>=20% from Baseline and an absolute improvement from Baseline of \>=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a \>=20% worsening and an absolute worsening of \>=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.
EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units
The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6.
| Arm | Type | Description |
|---|---|---|
| Golimumab→Golimumab | EXPERIMENTAL | In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.) |
| Placebo→Golimumab | PLACEBO_COMPARATOR | In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.) |
| SC-GLM50 | EXPERIMENTAL | In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment. |
| IV GLM 2 mg/kg + GLM50-SC | EXPERIMENTAL | After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment. |
| GLM50-SC | EXPERIMENTAL | After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment. |
| Name | Type | Description |
|---|---|---|
| Golimumab | BIOLOGICAL | Golimumab 50 mg SC injection every 4 weeks |
| Placebo | BIOLOGICAL | Placebo SC injection every 4 weeks |
| SC golimumab | BIOLOGICAL | Subcutaneous golimumab at a dose of 50 mg administered once monthly. |
| IV golimumab | BIOLOGICAL | Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight. |
Inclusion Criteria: * Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration * Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 ...
Golimumab is used to treat rheumatoid arthritis and ankylosing spondylitis, a form of spondylitis. It is studied in adults 18 years and older with active disease. In rheumatoid arthritis it is given subcutaneously alongside disease-modifying antirheumatic drugs, and it is also studied in active axial spondyloarthritis.
Golimumab targets TNF, tumor necrosis factor. It is a monoclonal antibody that acts as a TNF inhibitor, binding this inflammatory cytokine and reducing the inflammatory signaling that drives joint and spine disease in rheumatoid arthritis and ankylosing spondylitis.
Golimumab is developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsors the clinical development program for the drug, including the Phase 3 studies conducted in rheumatoid arthritis and ankylosing spondylitis.
Golimumab is in Phase 3 clinical development for its arthritis and spondylitis indications. It is an investigational monoclonal antibody, and the Phase 3 trials supporting these programs have been completed.
Golimumab has been studied in completed Phase 3 trials including NCT00975130, which evaluated subcutaneous golimumab plus DMARDs in rheumatoid arthritis, and NCT01453725, which evaluated golimumab in participants with active axial spondyloarthritis. Both trials enrolled adults 18 years and older.
Yes, SC golimumab refers to the subcutaneous formulation of golimumab. The abbreviation SC stands for subcutaneous, describing the route of administration used in the Phase 3 rheumatoid arthritis trial that combined subcutaneous golimumab with disease-modifying antirheumatic drugs.