For US Healthcare Professionals

I am a

STUDY DESIGN

TREMFYA® was evaluated in QUASAR:
a phase 3 clinical trial program in adult patients with moderately to severely active UCUC1,2

  • This study program was a multicenter, randomized, double-blind, placebo-controlled induction study (N=701) and maintenance study (N=568) in adult patients with moderately to severely active UC who had an inadequate response, loss of response, or intolerance to corticosteroids, conventional immunomodulators, biologic therapy (tumor necrosis factor [TNF] blockers, vedolizumab), and/or a Janus kinase (JAK) inhibitor1

Patients from a phase 2b induction dose–finding study who demonstrated a clinical response to TREMFYA® treatment were also randomized into the phase 3 maintenance study.1,2

*Placebo nonresponders at Week 12 went on to receive TREMFYA® 200 mg IV q4w for 12 weeks, and clinical responders to TREMFYA® at Week 24 were randomized into the maintenance study.2

†Participants who complete the safety and efficacy evaluations at Week 44 of the maintenance study and who may benefit from continued treatment have the opportunity to participate in the LTE of the maintenance study for up to an additional 4 years of treatment to evaluate the efficacy and safety of long-term maintenance treatment.2

IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

Inclusion criteria2

  • Aged ≥18 years
  • Moderately to severely active UC, defined by modified Mayo score*†
  • Screening endoscopy with Mayo endoscopy subscore of ≥2 as obtained during the central review of the video endoscopy
  • Inadequate response or intolerance to conventional therapy (ie, corticosteroids, 6-mercaptopurine, or azathioprine) and/or biologics/JAKi (tumor necrosis factor alpha antagonists, vedolizumab, or tofacitinib)

Exclusion criteria2

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn’s disease (CD) or clinical findings suggestive of CD
  • UC limited to the rectum only or <20 cm of the colon
  • Presence of a stoma
  • Presence or history of a fistula
  • Receiving prohibited medications and/or treatment
  • Severe extensive colitis as evidenced by:
    • current hospitalization for the treatment of UC,
    • investigator judgment that the participant is likely to require a colectomy within 12 weeks of baseline,
    • symptom complex at screening or baseline visits that includes ≥4 of the following:
      • diarrhea with ≥6 bowel movements/day with macroscopic blood in stool, focal severe or rebound abdominal tenderness, persistent fever (temperature ≥38°C), tachycardia (>100 beats/minute), and anemia (hemoglobin <8.5 g/dL)

*Moderately to severely active ulcerative colitis was defined as a modified Mayo score between 5 and 9. The studies also enrolled patients with a baseline modified Mayo score of 4.2

*Moderately to severely active UC was defined as a modified Mayo score between 5 and 9. The studies also enrolled patients with a baseline modified Mayo score of 4.2

†Mayo rectal bleeding subscore of ≥1 at baseline and an endoscopy subscore of 2 or 3.2

‡To be naïve to advanced therapy such as TNFα antagonists, vedolizumab, or tofacitinib, OR to have no history of failure to respond to or tolerate advanced therapy AND have a prior or current UC medication history that includes one or more of the following: 1) Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-MP or AZA) OR 2) History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR 3) History of corticosteroid dependence (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC).2

JAKi=Janus kinase inhibitor.

TREMFYA®
100 mg SC q8wTREMFYA®
200 mg SC q4wPlacebo
SCTotal

Analysis set: randomized full

N=188

N=190

N=190

N=568

Age, years—mean (SD)40.3 (13.0)40.6 (14.7)41.2 (13.6)40.7 (13.8)
Biologic/JAKi-naïve, n (%)105 (56%)96 (51%)108 (57%)309 (54%)
Biologic/JAKi-failure, n (%)77 (41%)88 (46%)75 (40%)240 (42%)
Male, n (%)102 (54.3%)100 (52.6%)109 (57.4%)311 (54.8%)
Region, n (%)
Asia36 (19.1%)42 (22.1%)30 (15.8%)108 (19.0%)
Eastern Europe85 (45.2%)88 (46.3%)102 (53.7%)275 (48.4%)
Rest of world67 (35.6%)60 (31.6%)58 (30.5%)185 (32.6%)
Race—white, n (%)139 (73.9%)135 (71.1%)142 (74.7%)416 (73.2%)
UC disease duration, years—mean (SD)7.78 (8.5)8.35 (8.4)7.3 (6.3)7.81 (7.8)
Median (IQR)5.1 (2.0; 9.7)6.1 (2.2; 11.1)5.1 (2.8; 10.5)5.39 (2.5; 10.8)
Extensive UC disease,* n (%)79 (42.0%) 83 (43.7%)95 (50.0%)257 (45.2%)
Modified Mayo score—mean (SD)6.8 (1.15)6.9 (1.10)7.0 (1.09)6.9 (1.12)
Modified Mayo score of 7-9 (severe), n (%)114 (60.6%)124 (65.3%)125 (65.8%)363 (63.9%)
Mayo endoscopy subscore of 3 (severe), n (%)125 (66.5%)123 (64.7%)129 (67.9%)377 (66.4%)
CRP, median in mg/L (IQR)3.9 (1.4; 10.4)3.6 (1.4; 9.1)4.2 (1.6; 8.4)3.9 (1.5; 9.2)
Abnormal CRP (>3 mg/L), n (%)104 (56.2%)104 (55.6%)117 (61.6%)325 (57.8%)
Fecal calprotectin (mg/kg), median in mg/kg (IQR)1675.0 (806.0;
3543.5)		1487.0 (603.0;
3019.0)		1642.0 (663.0;
3498.0)		1605.0 (669.0;
3337.0)
Abnormal fecal calprotectin (>250 mg/kg), n (%)141 (88.1%)150 (87.7%)154 (88.0%)445 (87.9%)
TREMFYA®
100 mg SC q8w
Analysis set: randomized fullN=188
Age, years—mean (SD)40.3 (13.0)
Biologic/JAKi-naïve, n (%)105 (56%)
Biologic/JAKi-failure, n (%)77 (41%)
Male, n (%)102 (54.3%)
Region, n (%)
Asia36 (19.1%)
Eastern Europe85 (45.2%)
Rest of world67 (35.6%)
Race—white, n (%)139 (73.9%)
UC disease duration, years—mean (SD)7.78 (8.5)
Median (IQR)5.1 (2.0; 9.7)
Extensive UC disease,* n (%)79 (42.0%) 
Modified Mayo score—mean (SD)6.8 (1.15)
Modified Mayo score of 7-9 (severe), n (%)114 (60.6%)
Mayo endoscopy subscore of 3 (severe), n (%)125 (66.5%)
CRP, median in mg/L (IQR)3.9 (1.4; 10.4)
Abnormal CRP (>3 mg/L), n (%)104 (56.2%)
Fecal calprotectin (mg/kg), median in mg/kg (IQR)1675.0 (806.0;
3543.5)
Abnormal fecal calprotectin (>250 mg/kg), n (%)141 (88.1%)
TREMFYA®
200 mg SC q4w
Analysis set: randomized fullN=190
Age, years—mean (SD)40.6 (14.7)
Biologic/JAKi-naïve, n (%)96 (51%)
Biologic/JAKi-failure, n (%)88 (46%)
Male, n (%)100 (52.6%)
Region, n (%)
Asia42 (22.1%)
Eastern Europe88 (46.3%)
Rest of world60 (31.6%)
Race—white, n (%)135 (71.1%)
UC disease duration, years—mean (SD)8.35 (8.4)
Median (IQR)6.1 (2.2; 11.1)
Extensive UC disease,* n (%)83 (43.7%)
Modified Mayo score—mean (SD)6.9 (1.10)
Modified Mayo score of 7-9 (severe), n (%)124 (65.3%)
Mayo endoscopy subscore of 3 (severe), n (%)123 (64.7%)
CRP, median in mg/L (IQR)3.6 (1.4; 9.1)
Abnormal CRP (>3 mg/L), n (%)104 (55.6%)
Fecal calprotectin (mg/kg), median in mg/kg (IQR)1487.0 (603.0;
3019.0)
Abnormal fecal calprotectin (>250 mg/kg), n (%)150 (87.7%)
Placebo
SC
Analysis set: randomized fullN=190
Age, years—mean (SD)41.2 (13.6)
Biologic/JAKi-naïve, n (%)108 (57%)
Biologic/JAKi-failure, n (%)75 (40%)
Male, n (%)109 (57.4%)
Region, n (%)
Asia30 (15.8%)
Eastern Europe102 (53.7%)
Rest of world58 (30.5%)
Race—white, n (%)142 (74.7%)
UC disease duration, years—mean (SD)7.3 (6.3)
Median (IQR)5.1 (2.8; 10.5)
Extensive UC disease,* n (%)95 (50.0%)
Modified Mayo score—mean (SD)7.0 (1.09)
Modified Mayo score of 7-9 (severe), n (%)125 (65.8%)
Mayo endoscopy subscore of 3 (severe), n (%)129 (67.9%)
CRP, median in mg/L (IQR)4.2 (1.6; 8.4)
Abnormal CRP (>3 mg/L), n (%)117 (61.6%)
Fecal calprotectin (mg/kg), median in mg/kg (IQR)1642.0 (663.0;
3498.0)
Abnormal fecal calprotectin (>250 mg/kg), n (%)154 (88.0%)
Total
Analysis set: randomized fullN=568
Age, years—mean (SD)40.7 (13.8)
Biologic/JAKi-naïve, n (%)309 (54%)
Biologic/JAKi-failure, n (%)240 (42%)
Male, n (%)311 (54.8%)
Region, n (%)
Asia108 (19.0%)
Eastern Europe275 (48.4%)
Rest of world185 (32.6%)
Race—white, n (%)416 (73.2%)
UC disease duration, years—mean (SD)7.81 (7.8)
Median (IQR)5.39 (2.5; 10.8)
Extensive UC disease,* n (%)257 (45.2%)
Modified Mayo score—mean (SD)6.9 (1.12)
Modified Mayo score of 7-9 (severe), n (%)363 (63.9%)
Mayo endoscopy subscore of 3 (severe), n (%)377 (66.4%)
CRP, median in mg/L (IQR)3.9 (1.5; 9.2)
Abnormal CRP (>3 mg/L), n (%)325 (57.8%)
Fecal calprotectin (mg/kg), median in mg/kg (IQR)1605.0 (669.0;
3337.0)
Abnormal fecal calprotectin (>250 mg/kg), n (%)445 (87.9%)

*Involvement extends proximal to splenic flexure.2

CRP=C-reactive protein; IQR=interquartile range; JAKi=Janus kinase inhibitor; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; SD=standard deviation.

PRIMARY ENDPOINTS

TREMFYA® reached statistically significant remission

QUASAR achieved its primary endpoints1

  • Clinical Remission at Week 12 (induction phase): 23% TREMFYA® 200 mg IV (q4w) (95/421) vs 8% placebo (22/280) (P<0.001)‡§
  • Clinical Remission at Week 44 (maintenance phase): 50% TREMFYA® 200 mg SC (q4w) (95/190) vs 19% placebo (36/190) (P<0.001)‡§
    • 45% TREMFYA® 100 mg SC (q8w) (85/188) vs 19% placebo (36/190) (P<0.001)

Use the lowest effective recommended dosage to maintain therapeutic response.

Clinical remission* includes remission of symptoms and improvement in endoscopy

Use the lowest effective recommended dosage to maintain therapeutic response.

*Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.1

*Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0 (remission of symptoms), and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy (improvement in endoscopy).1

†The modified Mayo score includes the 3-component Mayo score (stool frequency, rectal bleeding, and endoscopy subscores) without the physician’s global assessment.1

IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

‡Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.2

§The modified Mayo score includes the 3-component Mayo score (stool frequency, rectal bleeding, and endoscopy subscores) without the physician’s global assessment.2

IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.

global

Schedule a meeting with a local representative of Johnson & Johnson

Request a rep
Explore TREMFYA® Efficacy

References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.​ 2. Data on file. Janssen Biotech, Inc.