Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infliximab · 12 trials · 7 indications
ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).
The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. "Extent" is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement.
Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.
PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
\>=20% improvement in swollen and tender joint count AND \>=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
Difference in mean serum CRP measured on (summated as AUC) in the active arms (5 mg/kg or 10 mg/kg) versus the placebo arm. CRP assays will be undertaken on blood samples centrally to ensure standardised measurement, and when central measurements of CRP at specific time points are not available for any patient, CRP measures from that patient's specific recruiting centre will be sought.
Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).
PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
| Arm | Type | Description |
|---|---|---|
| Infliximab + Naproxen | EXPERIMENTAL | Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase. |
| Placebo + Naproxen | PLACEBO_COMPARATOR | Placebo administered intravenously on Day 1 at Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase. |
| Naproxen Only (Follow-Up) | EXPERIMENTAL | For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase. |
| No Treatment (Follow-Up) | NO_INTERVENTION | For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase. |
| Infliximab 5 mg/kg | EXPERIMENTAL | Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12. |
| Open Label Infliximab + Methotrexate | EXPERIMENTAL | Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX) |
| Infliximab + methotrexate (IFX + MTX) | EXPERIMENTAL | Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week |
| Methotrexate (MTX) | ACTIVE_COMPARATOR | Oral methotrexate (MTX) 15 mg/week |
| Infliximab | EXPERIMENTAL | - |
| Methotrexate | ACTIVE_COMPARATOR | - |
| Group 1 (high-need) | EXPERIMENTAL | Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). |
| Group II (low-need) | EXPERIMENTAL | Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). |
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| Infusion of 5 mg/kg Infliximab | ACTIVE_COMPARATOR | Infliximab (Remicade) to be administered as a one time intravenous infusion in 250 ml (500 ml if patient weighs over 100 kg) 0.9% sodium chloride solution over a period of 2 hours. Dosage calculated at 5 mg of Infliximab, per kg of patient body weight. |
| Infusion of 10 mg/kg Infliximab | ACTIVE_COMPARATOR | Infliximab (Remicade) to be administered as a one time intravenous infusion in 250 ml (500 ml if patient weighs over 100 kg) 0.9% sodium chloride solution over a period of 2 hours. Dosage calculated at 10 mg of Infliximab, per kg of patient body weight. |
| 0.9% Sodium Chloride (Placebo) | PLACEBO_COMPARATOR | 250 ml (500 ml if patient weighs over 100 kg) 0.9% Sodium Chloride to be administered as a one time intravenous infusion over a period of 2 hours. |
| Placebo | PLACEBO_COMPARATOR | saline via intravenous infusion |
| Name | Type | Description |
|---|---|---|
| Infliximab | DRUG | - |
| Placebo | DRUG | - |
| Naproxen | DRUG | - |
| Infliximab + methotrexate (MTX) | BIOLOGICAL | Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX) |
| Infliximab + methotrexate (IFX + MTX) | DRUG | Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6. |
| Methotrexate (MTX) | DRUG | Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6. |
| methotrexate | DRUG | Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks. |
| MTX | DRUG | Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose \>=12.5 mg/week given orally or parenterally, maximum 20 mg/week |
| Infusion of 5 mg/kg Infliximab | DRUG | Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP). |
| Infusion of 10 mg/kg Infliximab | DRUG | Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP). |
| 0.9% Sodium Chloride (Placebo) | OTHER | 250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride |
Inclusion Criteria: Participant must: * be 18 to 48 years of age * have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years. * have active disease during trial enrollment * have limited treatment history for axial spondyloarthritis (must meet certain...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | - | Secukinumab |
| Pfizer Inc. | PFE | 1 | - | Tofacitinib |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |