Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01710358 RA-BEAM | Arthritis, Rheumatoid | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) Week 12 | Adalimumab | 61.2 percentage of participants |
| Baricitinib | 69.6 percentage of participants | |||
| Placebo | 40.2 percentage of participants | |||
| NCT01711359 RA-BEGIN | Arthritis, Rheumatoid | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) Week 24 | Baricitinib | 73.0 Percent of participants |
| Baricitinib | 76.7 Percent of participants | |||
| Baricitinib + MTX | 78.1 Percent of participants | |||
| Baricitinib + MTX | 72.6 Percent of participants | |||
| Methotrexate | 61.9 Percent of participants | |||
| Methotrexate | 55.7 Percent of participants | |||
| NCT01721044 RA-BEACON | Arthritis, Rheumatoid | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg Week 12 | Baricitinib 4 mg | 55.4 Percentage of Participants |
| Placebo | 27.3 Percentage of Participants | |||
| NCT01721057 RA-BUILD | Arthritis, Rheumatoid | Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) Week 12 | Baricitinib 2 mg | 65.9 percentage of participants |
| Baricitinib 4 mg | 61.7 percentage of participants | |||
| Placebo | 39.5 percentage of participants | |||
| NCT01885078 RA-BEYOND | Arthritis, Rheumatoid | Number of Participants Who Experienced Adverse Events (AEs) or Serious AE Baseline through 84 Months | 2 mg Baricitinib | 112 participants |
| 2 mg Baricitinib | 234 participants | |||
| 2 mg Baricitinib Step-down | 270 participants | |||
| 2 mg Baricitinib Step-down | 164 participants | |||
| 4 mg Baricitinib | 1532 participants | |||
| 4 mg Baricitinib | 517 participants | |||
| 4 mg Baricitinib Step-down | 178 participants | |||
| 4 mg Baricitinib Step-down | 315 participants | |||
| NCT02265705 | Arthritis, Rheumatoid | Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Week 12 | Baricitinib | 58.6 percentage of participants |
| Placebo | 28.3 percentage of participants | |||
| NCT03334396 BREEZE-AD1 | Dermatitis, Atopic | Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib) 16 Weeks | 2 mg Baricitinib | 11.4 percentage of participants |
| 4 mg Baricitinib | 16.8 percentage of participants | |||
| Placebo | 4.8 percentage of participants | |||
| NCT03334422 BREEZE-AD2 | Dermatitis, Atopic | Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib) 16 Weeks | 2mg Baricitinib | 10.6 percentage of participants |
| 4mg Baricitinib | 13.8 percentage of participants | |||
| Placebo | 4.5 percentage of participants | |||
| NCT03334435 BREEZE-AD3 | Dermatitis, Atopic | Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 Weeks 16, 36 and 52 | RPR-Bari 1-mg | 35.6 Percentage of participants |
| RPR-Bari 1-mg | 46.7 Percentage of participants | |||
| RPR-Bari 1-mg | 31.1 Percentage of participants | |||
| RPR-Bari 2-mg | 50.0 Percentage of participants | |||
| RPR-Bari 2-mg | 63.0 Percentage of participants | |||
| RPR-Bari 2-mg | 59.3 Percentage of participants | |||
| RPR-Bari 4-mg | 48.6 Percentage of participants | |||
| RPR-Bari 4-mg | 40.0 Percentage of participants | |||
| RPR-Bari 4-mg | 37.1 Percentage of participants | |||
| RPR-Placebo | 28.8 Percentage of participants | |||
| RPR-Placebo | 36.5 Percentage of participants | |||
| RPR-Placebo | 23.1 Percentage of participants | |||
| NCT03334435 BREEZE-AD3 | Dermatitis, Atopic | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 Weeks 16, 36, and 52 | RPR-Bari 2-mg | 30.2 Percentage of participants |
| RPR-Bari 2-mg | 24.5 Percentage of participants | |||
| RPR-Bari 2-mg | 45.3 Percentage of participants | |||
| RPR-Bari 4-mg | 31.7 Percentage of participants | |||
| RPR-Bari 4-mg | 31.7 Percentage of participants | |||
| RPR-Bari 4-mg | 30.2 Percentage of participants | |||
| RPR-Placebo | 29.4 Percentage of participants | |||
| RPR-Placebo | 41.2 Percentage of participants | |||
| RPR-Placebo | 47.1 Percentage of participants | |||
| NCT03428100 BREEZE-AD4 | Dermatitis, Atopic | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib) Week 16 | 2 mg Baricitinib | 27.6 percentage of participants |
| 4 mg Baricitinib | 31.5 percentage of participants | |||
| Placebo | 17.2 percentage of participants | |||
| NCT03435081 BREEZE-AD5 | Dermatitis, Atopic | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) Week 16 | 2 mg Baricitinib | 29.5 percentage of participants |
| Placebo | 8.2 percentage of participants | |||
| NCT03559270 BREEZE-AD6 | Dermatitis, Atopic | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) Week 16 | Baricitinib 1-mg/Baricitinib 2-mg | 40.3 percentage of participants |
| Baricitinib 2-mg Open-Label Addendum | 50.0 percentage of participants | |||
| Baricitinib 2-mg/Baricitinib 2-mg | 45.4 percentage of participants | |||
| Placebo/Baricitinib 2-mg | 59.0 percentage of participants | |||
| NCT03570749 BRAVE-AA1 | Alopecia Areata | Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum Baseline, Week 52 | 4 mg Baricitinib Phase 3 Open-Label Addendum | -40.44 percent change (±33.182 Standard Deviation) |
| NCT03570749 BRAVE-AA1 | Alopecia Areata | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 Week 36 | 2 mg Baricitinib Phase 3 | 21.7 percentage of participants |
| 4 mg Baricitinib Phase 3 | 35.2 percentage of participants | |||
| Placebo Phase 3 | 5.3 percentage of participants | |||
| NCT03616912 SLE-BRAVE I | Lupus Erythematosus, Systemic | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) Week 52 | 4 mg Baricitinib | 56.7 percentage of participants |
| Placebo | 45.9 percentage of participants | |||
| NCT03616964 BRAVE II | Lupus Erythematosus, Systemic | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) Week 52 | 4 mg Baricitinib | 47.1 percentage of participants |
| Placebo | 45.6 percentage of participants | |||
| NCT03733301 BREEZE-AD7 | Dermatitis, Atopic | Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement Week 16 | 2 mg Baricitinib | 23.9 percentage of participants |
| 4 mg Baricitinib | 30.6 percentage of participants | |||
| Placebo | 14.7 percentage of participants | |||
| NCT03773978 JUVE-BASIS | Arthritis | Time to Disease Flare Week 12 to Week 44 | Baricitinib | NA Weeks |
| Placebo | 27.14 Weeks | |||
| NCT03843125 SLE-BRAVE-X | Lupus Erythematosus, Systemic | Percentage of Participants With Adverse Events of Special Interest (AESIs) Week 134 | 2 mg Baricitinib | 0.3 Percentage of participants |
| 2 mg Baricitinib | 38.4 Percentage of participants | |||
| 2 mg Baricitinib | 0 Percentage of participants | |||
| 2 mg Baricitinib | 0.3 Percentage of participants | |||
| 2 mg Baricitinib | 0.3 Percentage of participants | |||
| 2 mg Baricitinib | 0.5 Percentage of participants | |||
| 2 mg Baricitinib | 3.6 Percentage of participants | |||
| 2 mg Baricitinib | 3.6 Percentage of participants | |||
| 2 mg Baricitinib | 0.3 Percentage of participants | |||
| 2 mg Baricitinib | 1.3 Percentage of participants | |||
| 4 mg Baricitinib | 1.6 Percentage of participants | |||
| 4 mg Baricitinib | 42.1 Percentage of participants | |||
| 4 mg Baricitinib | 0.8 Percentage of participants | |||
| 4 mg Baricitinib | 1.1 Percentage of participants | |||
| 4 mg Baricitinib | 0.8 Percentage of participants | |||
| 4 mg Baricitinib | 0.8 Percentage of participants | |||
| 4 mg Baricitinib | 4.2 Percentage of participants | |||
| 4 mg Baricitinib | 4.2 Percentage of participants | |||
| 4 mg Baricitinib | 0.8 Percentage of participants | |||
| 4 mg Baricitinib | 0.3 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 1.6 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 0 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 36.5 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 1.1 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 5.8 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 5.8 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 2 mg Baricitinib | 0 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 3.1 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 3.1 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 35.1 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0.5 Percentage of participants | |||
| Placebo to 4 mg Baricitinib | 0 Percentage of participants | |||
| NCT03843125 SLE-BRAVE-X | Lupus Erythematosus, Systemic | Percentage of Participants With Permanent Investigational Product Discontinuations Week 134 | 2 mg Baricitinib | 5.2 Percentage of Participants |
| 4 mg Baricitinib | 5.8 Percentage of Participants | |||
| Placebo to 2 mg Baricitinib | 4.2 Percentage of Participants | |||
| Placebo to 4 mg Baricitinib | 5.8 Percentage of Participants | |||
| NCT03843125 SLE-BRAVE-X | Lupus Erythematosus, Systemic | Percentage of Participants With Serious Adverse Events (SAEs) Week 134 | 2 mg Baricitinib | 11.1 Percentage of Participants |
| 4 mg Baricitinib | 13.5 Percentage of Participants | |||
| Placebo to 2 mg Baricitinib | 11.1 Percentage of Participants | |||
| Placebo to 4 mg Baricitinib | 11.5 Percentage of Participants | |||
| NCT03843125 SLE-BRAVE-X | Lupus Erythematosus, Systemic | Percentage of Participants With Temporary Investigational Product Interruptions Week 134 | 2 mg Baricitinib | 19.1 Percentage of Participants |
| 4 mg Baricitinib | 24.6 Percentage of Participants | |||
| Placebo to 2 mg Baricitinib | 18.5 Percentage of Participants | |||
| Placebo to 4 mg Baricitinib | 23.6 Percentage of Participants | |||
| NCT03843125 SLE-BRAVE-X | Lupus Erythematosus, Systemic | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Week 134 | 2 mg Baricitinib | 61.9 Percentage of Participants |
| 4 mg Baricitinib | 68.8 Percentage of Participants | |||
| Placebo to 2 mg Baricitinib | 65.1 Percentage of Participants | |||
| Placebo to 4 mg Baricitinib | 64.4 Percentage of Participants | |||
| NCT03899259 BRAVE-AA2 | Alopecia Areata | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 Week 36 | 2 mg Baricitinib | 17.3 percentage of participants |
| 4 mg Baricitinib | 32.5 percentage of participants | |||
| Placebo | 2.6 percentage of participants | |||
| NCT03952559 BREEZE-AD-PEDS | Dermatitis, Atopic | Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104 Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose | Baricitinib Open Label High Dose 10 to <18 | 290 hour*nanogram per milliliter (h*ng/mL) (±44 Geometric Coefficient of Variation) |
| Baricitinib Open Label High Dose 2 to <6 | 251 hour*nanogram per milliliter (h*ng/mL) (±18 Geometric Coefficient of Variation) | |||
| Baricitinib Open Label High Dose 6 to <10 | 178 hour*nanogram per milliliter (h*ng/mL) (±18 Geometric Coefficient of Variation) | |||
| NCT03952559 BREEZE-AD-PEDS | Dermatitis, Atopic | Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104 Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose | Baricitinib Open Label High Dose 10 to <18 | 50.6 nanogram per milliliter (ng/mL) (±29 Geometric Coefficient of Variation) |
| Baricitinib Open Label High Dose 2 to <6 | 63.2 nanogram per milliliter (ng/mL) (±30 Geometric Coefficient of Variation) | |||
| Baricitinib Open Label High Dose 6 to <10 | 40.1 nanogram per milliliter (ng/mL) (±32 Geometric Coefficient of Variation) | |||
| NCT03952559 BREEZE-AD-PEDS | Dermatitis, Atopic | Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement Week 16 | Baricitinib Double-blind High Dose | 41.7 Percentage of participants |
| Baricitinib Double-blind Low Dose | 18.2 Percentage of participants | |||
| Baricitinib Double-blind Medium Dose | 25.8 Percentage of participants | |||
| Placebo Double-blind | 16.4 Percentage of participants | |||
| NCT04088409 | Uveitis | Part A: Percentage of Responders for Baricitinib at Week 24 Week 24 | Baricitinib | 33.3 Percentage of participants |
| NCT04401579 | COVID-19 | Time to Recovery Day 1 through Day 29 | Remdesivir Plus Baricitinib | 7.0 Days |
| Remdesivir Plus Placebo | 8.0 Days | |||
| NCT04401579 | COVID-19 | Time to Recovery by Ethnicity Day 1 through Day 29 | Remdesivir Plus Baricitinib | 7.0 Days |
| Remdesivir Plus Baricitinib | 7.0 Days | |||
| Remdesivir Plus Placebo | 9.0 Days | |||
| Remdesivir Plus Placebo | 7.0 Days | |||
| NCT04401579 | COVID-19 | Time to Recovery by Race Day 1 through Day 29 | Remdesivir Plus Baricitinib | 10 Days |
| Remdesivir Plus Baricitinib | 7.0 Days | |||
| Remdesivir Plus Baricitinib | 7.0 Days | |||
| Remdesivir Plus Baricitinib | 7.0 Days | |||
| Remdesivir Plus Placebo | 8.0 Days | |||
| Remdesivir Plus Placebo | 7.0 Days | |||
| Remdesivir Plus Placebo | 6.0 Days | |||
| Remdesivir Plus Placebo | 10.0 Days | |||
| NCT04401579 | COVID-19 | Time to Recovery by Sex Day 1 through Day 29 | Remdesivir Plus Baricitinib | 7.0 Days |
| Remdesivir Plus Baricitinib | 7.0 Days | |||
| Remdesivir Plus Placebo | 9.0 Days | |||
| Remdesivir Plus Placebo | 7.0 Days | |||
| NCT04421027 COV-BARRIER | COVID-19 | Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2 Day 1 to Day 28 | Baricitinib + SOC | 28.9 percentage of participants |
| Placebo + SOC | 27.1 percentage of participants | |||
| NCT04421027 COV-BARRIER | COVID-19 | Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) Day 1 to Day 28 | Baricitinib + SOC | 27.8 percentage of participants |
| Placebo + SOC | 30.5 percentage of participants | |||
| NCT04517253 | Aicardi-Goutieres syndrome | Change From Baseline in Mean Daily Diary Scores in Participants With AGS (Primary Treatment Period) Baseline, 32 weeks | Aicardi-Goutières Syndrome (AGS) | -0.045 score on a scale (±0.164 Standard Deviation) |
| NCT04517253 | Aicardi-Goutieres syndrome | Change From Baseline in Mean Daily Diary Scores in Participants With CANDLE (Primary Treatment Period) Baseline, 20 weeks | CANDLE | -0.217 score on a scale (±0.586 Standard Deviation) |
| NCT04517253 | Aicardi-Goutieres syndrome | Change From Baseline in Mean Daily Diary Scores in Participants With SAVI (Primary Treatment Period) Baseline, 32 weeks | SAVI | -0.23 score on a scale (±0.238 Standard Deviation) |
| NCT04640168 | COVID-19 | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Day 1 through Day 29 | Remdesivir Plus Baricitinib | 0.87 Proportion of participants |
| Remdesivir Plus Dexamethasone | 0.88 Proportion of participants | |||
| NCT04640168 | COVID-19 | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity Day 1 through Day 29 | Remdesivir Plus Baricitinib | 0.87 Proportion of participants |
| Remdesivir Plus Baricitinib | 0.88 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.87 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.87 Proportion of participants | |||
| NCT04640168 | COVID-19 | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race Day 1 through Day 29 | Remdesivir Plus Baricitinib | 0.87 Proportion of participants |
| Remdesivir Plus Baricitinib | 0.91 Proportion of participants | |||
| Remdesivir Plus Baricitinib | 0.76 Proportion of participants | |||
| Remdesivir Plus Baricitinib | 0.87 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.86 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.88 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.88 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.89 Proportion of participants | |||
| NCT04640168 | COVID-19 | The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex Day 1 through Day 29 | Remdesivir Plus Baricitinib | 0.86 Proportion of participants |
| Remdesivir Plus Baricitinib | 0.89 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.87 Proportion of participants | |||
| Remdesivir Plus Dexamethasone | 0.88 Proportion of participants |