parallel randomized trial

TOGETHER-PsA

Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)

Overweight or obesity without diabetes (adults)Other conditions NCT06588296S001889

Design

Randomized: 279
Start year: 2024
Treatment: 52 weeks
Countries: United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 to 80; active psoriatic arthritis; BMI 30 or more, or 27 to 30 with a weight related comorbidity

Conduct and analysis

Blinding: single blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Ixekizumab alone	ixekizumab 160 mg then 80 mg Q4W; dietician counseling; lifestyle: standard		133	89
A2	Tirzepatide maximum tolerated dose injection once weekly Ixekizumab plus tirzepatide MTD	ixekizumab 160 mg then 80 mg Q4W; dietician counseling; lifestyle: standard		138	116

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Standard care or no added treatment A1	Tirzepatide maximum tolerated dose injection once weekly A2
age	mean (years)	54.8	55.3
age	sd (years)	11.9	11.8
asian	n	2	4
asian	percent	1.5	2.9
black	n	6	3
black	percent	4.5	2.2
bmi	mean (kg/m2)	38.3	37.0
bmi	sd (kg/m2)	7.4	7.8
established cvd	n	11	13
established cvd	percent	8.3	9.4
female	n	92	97
female	percent	69.2	70.3
hba1c	mean (percent)	5.8	5.8
hba1c	sd (percent)	0.7	0.8
hispanic	n	35	36
hispanic	percent	26.3	26.1
other race multiple	n	3	2
other race multiple	percent	2.3	1.4
sbp	mean (mmHg)	132.5	130.3
sbp	sd (mmHg)	14.9	13.1
weight	mean (kg)	107.6	104.6
weight	sd (kg)	24.4	25.2
white	n	109	119
white	percent	82.0	86.2

Analyses this trial contributes to

Results

42 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	change	-3.93 mmHg		133	hypothetical; modified itt; R0018951:Table 2
36	A2	change	-10.81 mmHg		138	hypothetical; modified itt; R0018951:Table 2
36	A2 vs A1	md	-6.88 mmHg	-10.31 to -3.46		hypothetical; modified itt; R0018951:Table 2

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	percent change	-0.8 percent		133	hypothetical; modified itt; R0018951:Supplement Figure S2
24	A2	percent change	-13.7 percent		138	hypothetical; modified itt; R0018951:Supplement Figure S2
36	A1	percent change	-1.1 percent		133	hypothetical; modified itt; R0018951:Table 2
36	A2	percent change	-18.0 percent		138	hypothetical; modified itt; R0018951:Table 2
36	A2 vs A1	md	-16.9 percent	-18.6 to -15.2		hypothetical; modified itt; R0018951:Table 2

Weight loss of 10 percent or more (3 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	responders	4.5		133	hypothetical; modified itt; R0018951:Results
36	A2	responders	84.5		138	hypothetical; modified itt; R0018951:Results
36	A2 vs A1	rd	80.0	72.2 to 87.9		hypothetical; modified itt; R0018951:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 132	not stated; safety; R0018951:Table 3
	A2	events				0 / 138	not stated; safety; R0018951:Table 3

SF-36 physical component summary change (3 lines; O24A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	change	6.2 points		133	hypothetical; modified itt; R0018951:Table 2
36	A2	change	9.7 points		138	hypothetical; modified itt; R0018951:Table 2
36	A2 vs A1	md	3.5 points	1.5 to 5.6		hypothetical; modified itt; R0018951:Table 2

Physical functioning (any instrument) (3 lines; O24B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	change	-0.3 points		133	hypothetical; modified itt; R0018951:Table 2
36	A2	change	-0.5 points		138	hypothetical; modified itt; R0018951:Table 2
36	A2 vs A1	md	-0.2 points	-0.3 to -0.1		hypothetical; modified itt; R0018951:Table 2

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	change	-2.0 points		133	hypothetical; modified itt; R0018951:Table 2
36	A2	change	-2.7 points		138	hypothetical; modified itt; R0018951:Table 2
36	A2 vs A1	md	-0.7 points	-1.2 to -0.2		hypothetical; modified itt; R0018951:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 132	not stated; safety; R0018951:Table 3
	A2	events				5 / 138	not stated; safety; R0018951:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 132	not stated; safety; R0018951:Table 3
	A2	events				7 / 138	not stated; safety; R0018951:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 132	not stated; safety; R0018951:Table 3
	A2	events				41 / 138	not stated; safety; R0018951:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 132	not stated; safety; R0018951:Table 3
	A2	events				15 / 138	not stated; safety; R0018951:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 132	not stated; safety; R0018951:Table 3
	A2	events				25 / 138	not stated; safety; R0018951:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 132	not stated; safety; R0018951:Table 3
	A2	events				23 / 138	not stated; safety; R0018951:Table 3

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 132	not stated; safety; R0018951:Table 3
	A2	events				4 / 138	not stated; safety; R0018951:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 132	not stated; safety; R0018951:Table 3
	A2	events				0 / 138	not stated; safety; R0018951:Table 3

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 132	not stated; safety; R0018951:Table 3
	A2	events				0 / 138	not stated; safety; R0018951:Table 3

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 132	not stated; safety; R0018951:Table 3
	A2	events				0 / 138	not stated; safety; R0018951:Table 3