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TREMFYA® (guselkumab)

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TREMFYA - Early Disease Intervention in Treatment of Adult Patients with Psoriasis/GUIDE Study

Last Updated: 01/04/2025

SUMMARY

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • A phase 3b, randomized, double-blind, parallel group, multicenter study (GUIDE) evaluated the safety and efficacy of TREMFYA in super responder (SR) and nonsuper responder (nSR) adult patients with moderate to severe plaque psoriasis (PsO).1
    • The primary endpoint of noninferiority of TREMFYA every 16 weeks (q16w) vs every 8 weeks (q8w) for the maintenance of disease control (Psoriasis Area and Severity Index [PASI] <3) was met in SRs at week 68.2
    • TREMFYA was well tolerated with a similar incidence of adverse events (AEs), regardless of dosing interval.2-6
    • At week 116, the overall maintenance of response remained high in SRs. Additionally, SRs with short disease duration (SDD) vs long disease duration (LDD) had a greater median treatment-free duration and substantially higher rates of PASI response.7
    • After TREMFYA withdrawal in SRs who achieved PASI <3, those who lost disease control regained response upon initiating retreatment through week 116.8

CLINICAL DATA

Eyerich et al (2021)1 reported results from the GUIDE study, a phase 3b, randomized, double-blind, parallel group, multicenter study that evaluated the safety and efficacy of TREMFYA in adult patients with moderate to severe plaque PsO.

Study Design/Methods

  • The study consisted of screening, part 1 (weeks 0-28), part 2 (weeks 28-68), and part 3 (long-term extension, weeks 68-220).1-4,6
  • Patients who did not achieve the criteria of SRs (ie, nSRs) remained in the study with TREMFYA 100 mg q8w through week 68.1
    • SRs were defined as patients who experienced complete skin clearance (absolute PASI=0) at weeks 20 and 28 with TREMFYA 100 mg q8w.1
    • nSRs were defined as patients who had PASI >0 at weeks 20 or 28.1
  • The study design is presented in the Figure: GUIDE Study Design.

GUIDE Study Design1,2,9

Abbreviations: anti-TNF α, anti-tumor necrosis factor α; BCG, Bacille Calmette-Guerin; BSA, body surface area; DLQI, Dermatology Life Quality Index; GUS, guselkumab; HBV, hepatitis B virus; HCV, hepatitis C virus; IL, interleukin; nSRs, nonsuper responders; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; q8w, every 8 weeks; q16w, every 16 weeks; R, randomized; SRs, super responders; TB, tuberculosis; W, week.
aMethotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus.
bUnless 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline.
cRituximab, alemtuzumab, abatacept, or visilizumab

Part 1: Data through Week 28

Schäkel et al (2023)6 published interim results through week 28 (Part 1) of the GUIDE study in the overall population and in the subgroup of patients with SDD (PsO ≤2 years) and LDD (PsO >2 years).

Results

Baseline Characteristics and Identification of SRs
  • A total of 880 patients received TREMFYA in part 1 of the study, which comprised of 357 (40.6%) patients with SDD and 523 (59.4%) patients with LDD.3-6
  • Overall, 303 (34.4%) patients were SRs and 577 (65.6%) were nSRs. A higher proportion of patients with SDD vs LDD were SRs (43.7% [n=156/357] vs 28.1% [n=127/523], P<0.001).2,4-6
  • Baseline characteristics by disease duration and SR status are described in Table: Baseline Characteristics by Disease Duration and SR Status.

Baseline Characteristics by Disease Duration and SR Status4,6,10
SDD
(PsO Duration ≤2 Years)
LDD
(PsO Duration >2 Years)
Overall Population
SR
n=156
nSR
n=201
Total
n=357
SR
n=147
nSR
n=376
Total
n=523
SR
n=303
nSR
n=577
Total
n=880
Male, n (%)
106
(67.9)
137
(68.2)
243
(68.1)
100
(68.0)
277
(73.7)
377
(72.1)
206
(68.0)
414
(71.8)
620
(70.5)
Age, years, mean (SD)
35.9
(14.0)
43.6
(16.7)
40.3
(16.0)
43.1
(13.3)
44.5
(13.6)
44.1
(13.5)
39.4
(14.1)
44.2
(14.7)
42.5
(14.7)
Disease duration, years, mean (SD)
1.2
(0.6)
1.2
(0.6)
1.2
(0.6)
19.2
(12.3)
20.6
(13.5)
20.2
(13.1)
9.9
(12.4)
13.8
(14.3)
12.5
(13.8)
BMI, kg/m2, mean (SD)
26.4
(4.7)
28.8
(6.7)
27.8
(6.0)
27.7
(5.7)
29.1
(6.1)a
28.7
(6.0)a
27.0
(5.2)
29.0
(6.3)
28.3
(16.0)
PASI, mean (SD)
18.1
(6.9)
19.1
(8.9)
18.7
(8.1)
19.4
(8.1)
19.5
(7.7)
19.4
(7.8)
18.7
(7.5)
19.3
(8.1)
19.1
(7.9)
BSA, mean (SD)
23.5
(14.1)
27.6
(15.9)
25.8
(15.3)
26.6
(16.1)
26.9
(14.5)
26.8
(15.0)
25.0
(15.2)
27.1
(15.0)
26.4
(15.1)
PsA, active or inactive, n (%)
4
(2.6)
8
(4.0)
12
(3.4)
8
(5.4)
25
(6.6)
33
(6.3)
12
(4.0)
33
(5.7)
45
(5.1)
NAPPA, nail involvement, n (%)
54
(34.6)
83
(41.3)
137
(38.4)
78
(53.1)
239
(63.6)
317
(60.6)
132
(43.6)
322
(55.8)
454
(51.6)
Any prior PsO therapy, n (%)
150
(96.2)
191
(95.0)
341
(95.5)
147
(100)
376
(100)
523
(100)
297
(98.0)
567
(98.3)
864
(98.2)
Patients who never received any systemic and/or biologic therapy,b n (%)
119
(76.3)
150
(74.6)
269
(75.4)
51
(34.7)
115
(30.6)
166
(31.7)
170
(56.1)
265
(45.9)
435
(49.4)
Patients with prior systemic and/or biologic therapy,b n (%)
37
(23.7)
51
(25.4)
88
(24.6)
96
(65.3)
261
(69.4)
357
(68.3)
133
(43.9)
312
(54.1)
445
(50.6)
Topical therapy,b n (%)
83
(53.2)
103
(51.2)
186
(52.1)
22
(15.0)
49
(13.0)
71
(13.6)
105
(34.7)
152
(26.3)
257
(29.2)
Phototherapy,b n (%)
30
(19.2)
37
(18.4)
67
(18.8)
29
(19.7)
66
(17.6)
95
(18.2)
59
(19.5)
103
(17.9)
162
(18.4)
Conventional systemic,b n (%)
36
(23.1)
47
(23.4)
83
(23.2)
76
(51.7)
163
(43.4)
239
(45.7)
112
(37.0)
210
(36.4)
322
(36.6)
Biologic,b n (%)
1
(0.6)
4
(2.0)
5
(1.4)
20
(13.6)
98
(26.1)
118
(22.6)
21
(6.9)
102
(17.7)
123
(14.0)
Abbreviations: BMI, body mass index; BSA, body surface area; LDD, long disease duration; NAPPA, Nail Assessment in Psoriasis and Psoriatic Arthritis; nSR, nonsuper responder; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, psoriasis; SD, standard deviation; SDD, short disease duration; SR, super responder.
aBMI at baseline was not recorded for 1 patient.
bData were analyzed according to a mutually exclusive derivation procedure in which patients were counted in only one therapy regimen according to the following procedure: ‘topical’, all patients receiving ≥1 prior topical PsO treatment who did not receive a treatment of another type; ‘phototherapy’, all patients receiving ≥1 prior phototherapy PsO treatment who did not receive a treatment of another type except topical PsO treatment; ‘conventional systemic’, all patients receiving ≥1 prior non-biologic systemic PsO treatment who did not receive a treatment of another type except topical treatment or phototherapy; ‘biologic’, all patients receiving ≥1 prior biologic PsO treatment who did not receive a treatment of another type except topical treatment, phototherapy or conventional systemic treatment.

Proportion of Patients Achieving Relative PASI 90/75 and Absolute PASI <3/≤1/0 Response at Weeks 20 and 28 (NRI)4,6,10
Patients with PASI Score
SDD (PsO Duration ≤2 Years)
(n=357)
LDD (PsO Duration >2 Years)
(n=523)
Overall
(N=880)
Week 20
   PASI 90 response, %
78.4
70.4
73.6
P-Value
0.008
-
   PASI 75 response, %
89.1
91.0
90.2
   Absolute PASI <3, %
85.2
82.4
83.5
   Absolute PASI ≤1, %
67.8
54.3
59.8
   Absolute PASI=0, %
49.3
32.7
39.4
P-Value
<0.001
-
Week 28
   PASI 90 response, %
80.1
73.2
76.0
P-Value
0.019
-
   PASI 75 response, %
89.9
91.2
90.7
   Absolute PASI <3, %
86.8
83.9
85.1
   Absolute PASI ≤1, %
70.3
59.5
63.9
   Absolute PASI=0, %
51.8
39.4
44.4
P-Value
<0.001
-
P-values were not reported for the PASI 75 response, absolute PASI <3, and absolute PASI ≤1.
Abbreviations: LDD, long disease duration; NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; SDD, short disease duration.
  • At week 28, Dermatology Life Quality Index (DLQI) score of 0/1 was achieved by 59.4% (n=357) vs 62.0% (n=523) of patients with SDD vs LDD (P=0.444) and by 81.8% (n=303) vs 49.9% (n=577) of patients with SRs vs nSRs (P<0.001).6,10

Part 2: Data through Week 68

Schäkel et al (2022)2,3 presented results at week 68 (part 2) of the GUIDE study that evaluated TREMFYA 100 mg q16w (2a) vs q8w (2b) for the maintenance of disease control (PASI <3) in SRs at week 68 (primary endpoint).

Results

Baseline Characteristics

Baseline Characteristics by TREMFYA Treatment and SR Status2
Randomized SR Patients
nSR Patients
2a: TREMFYA 100 mg q8w (n=148)
2b: TREMFYA 100 mg q16w (n=149)
2a and 2b: Pooled TREMFYA q8w and q16w (n=297)
2c: TREMFYA 100 mg q8w (n=525)
Age, years, median (range)
36.5 (18.0-84.0)
37.0 (18.0-77.0)
37.0 (18.0-84.0)
44.0 (18.0-79.0)
Male, n (%)
95 (64.2)
107 (71.8)
202 (68.0)
380 (72.4)
BMI (categorical), n (%)a
   Normal,
   <25, kg/m2
58 (39.2)
60 (40.3)
118 (39.7)
145 (27.6)
   Overweight,
   >25-30, kg/m2
57 (38.5)
49 (32.9)
106 (35.7)
179 (34.1)
   Obese,
   >30, kg/m2
33 (22.3)
40 (26.8)
73 (24.6)
200 (38.1)
Disease duration (years)
   Mean (SD)
10.0 (12.6)
10.2 (12.4)
10.1 (12.5)
14.1 (14.4)
   Median (range)
2.1 (0.2-59.0)
2.0 (0.1-46.0)
2.0 (0.1-59.0)
10.0 (0.1-67.0)
PASI score at baselineb
   Mean (SD)
18.9 (8.1)
18.7 (7.1)
18.8 (7.6)
19.2 (8.1)
   Median (range)
16.7 (10.0-59.2)
16.7 (9.2-43.2)
16.7 (9.2-59.2)
16.8 (6.3-60.0)
DLQI score at baselineb
   Mean (SD)
19.4 (5.3)
18.5 (4.7)
18.9 (5.0)
19.2 (5.2)
   Median (range)
20.0 (11.0-30.0)
18.0 (11.0-29.0)
19.0 (11.0-30.0)
19.0 (11.0-30.0)
Prior psoriasis therapy (hierarchizedc), n (%)
   Any therapy
146 (98.6)
145 (97.3)
291 (98.0)
516 (98.3)
   Topical
57 (38.5)
45 (30.2)
102 (34.3)
140 (26.7)
   Phototherapy
31 (20.9)
27 (18.1)
58 (19.5)
92 (17.5)
   Nonbiologic
   systemic
51 (34.5)
59 (39.6)
110 (37.0)
191 (36.4)
   Biologic
7 (4.7)
14 (9.4)
21 (7.1)
93 (17.7)
Abbreviations:BMI, body mass index; DLQI, Dermatology Life Quality Index; nSR, nonsuper responder; PASI, Psoriasis Area and Severity Index; q8w, every 8 weeks; q16w, every 16 weeks; SD, standard deviation; SR, super responder.
aDocumentation of BMI was not recorded for 1 patient in the nSR group at baseline.
bWeek 0 or screening in Part 1.
cIn the hierarchized analysis, patients were counted in only 1 therapy regimen according to the following procedure: Topical→Phototherapy→Nonbiologic systemic→Biologic.
Efficacy
  • The proportion of SR patients that achieved PASI <3 at week 68 was 92.6% (137/148) in the TREMFYA 100 mg q8w treatment arm (2a) and 91.9% (137/149) in the TREMFYA 100 mg q16w treatment arm (2b) (noninferiority; P=0.001).2
  • Additional efficacy endpoints are described in Table: Efficacy Endpoints at Week 68 for SR and nSR Patients.
  • Of the 880 patients enrolled in the study, 303 (34.4%) were SR.2
    • The proportion of patients with SR status was greater in biologic-naïve patients (37.2%; 276/741) than biologic-experienced patients (≥1 biologic therapy; 17.1%; 21/123, P<0.001).

Efficacy Endpoints at Week 68 for SR and nSR Patients2,3
Randomized SR Patients
nSR Patients
2a: TREMFYA 100 mg q8w (n=148)
2b: TREMFYA 100 mg q16w (n=149)
2c: TREMFYA 100 mg q8w (n=525)
PASI <3,a %
92.6b
91.9b
82.9
PASI ≤1,a %
89.9c
79.2c
61.9
PASI=0,a %
81.1c
69.1c
38.1
Mean PASI scored
0.1
0.4
1.1
DLQI <5a
-
-
78.9
DLQI 0/1a
83.1e
77.9e
61.9
Abbreviations: DLQI, Dermatology Life Quality Index; nSR, nonsuper responder; PASI, Psoriasis Area and Severity Index; q8w, every 8 weeks; q16w, every 16 weeks; SR, super responder.aNonresponder imputation.
bTest for noninferiority (P=0.001), noninferiority was met when the 90% confidence interval lower limit for risk difference was >10%.
cNominal P-value <0.05 for TREMFYA q8w vs q16w. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
dAs-observed data.
eNominal P-value <0.001 for TREMFYA q8w vs q16w. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
  • At week 68, subgroup analyses demonstrated noninferiority of TREMFYA 100 mg q16w vs q8w in achieving PASI <3 in patients with SDD (93.4% vs 90.7%; odds ratio [OR], 1.46; 90% confidence interval [CI], 0.54-4.0; nominal P=0.005 for noninferiority), but not in patients with LDD (90.4% vs 94.5%; OR, 0.55; 90% CI, 0.19-1.59; nominal P=0.104).3
Safety
  • Overall, 58 (6.6%) patients withdrew from the study before week 28 (AEs, n=17; protocol violation, n=11; loss to follow-up, n=10).6
  • No new safety events were identified regardless of TREMFYA dosing interval.2 Safety events are described in Table: Safety Events in Part 1 (Weeks 0-28) and Part 2 (Weeks 28-68).
  • Treatment-emergent adverse events (TEAEs) led to treatment discontinuation in 1.9% (n=17) of patients.6
  • The overall incidence of treatment-emergent serious AEs was 4.7%, 4.0% and 6.3% in SR TREMFYA 100 mg q8w, SR TREMFYA 100 mg q16w, and nSR TREMFYA 100 mg q8w, respectively.3

Safety Events in Part 1 (Weeks 0-28) and Part 2 (Weeks 28-68)2,6
Part 1
(Weeks 0-28)6
Part 2 (Weeks 28-68)2
Randomized SR Patients
nSR Patients
TREMFYA 100 mg q8w (N=880)
2a: TREMFYA 100 mg q8w (n=148)
2b: TREMFYA 100 mg q16w (n=149)
2c: TREMFYA 100 mg q8w (n=525)
Total number of AEs, n
1602
313
249
955
Patients with ≥1 AE, n (%)
658 (74.8)
-
-
-
Patients with ≥1 SAE, n (%)
39 (4.4)
-
-
-
Patients with ≥1 TESAE, n (%)
38 (4.3)
-
-
-
Patients with ≥1 TEAE, n (%)
634 (72.0)
102 (68.9)
103 (69.1)
372 (70.9)
   Nasopharyngitis
214 (24.3)
26 (17.6)
23 (15.4)
97 (18.5)
   Headache
79 (9.0)
8 (5.4)
9 (6.0)
29 (5.5)
   Hypertension
48 (5.5)
4 (2.7)
5 (3.4)
31 (5.9)
   Arthralgia
41 (4.7)
5 (3.4)
5 (3.4)
29 (5.5)
   Back pain
26 (3.0)
6 (4.1)
8 (5.4)
13 (2.5)
   Influenza
8 (0.9)
5 (3.4)
5 (3.4)
6 (1.1)
   Increased blood creatine
   phosphokinase
20 (2.3)
3 (2.0)
6 (4.0)
8 (1.5)
   Diarrhea
24 (2.7)
5 (3.4)
1 (0.7)
13 (2.5)
   Injection-site erythema
8 (0.9)
6 (4.1)
-
5 (1.0)
Other TEAEs of interest, n (%)
   Hypersensitivity
1 (0.1)
1 (0.7)
1 (0.7)a
-
   Candida infectionb
6 (0.7)
2 (1.4)
2 (1.3)
6 (1.1)
   COVID-19
10 (1.1)
-
-
-
   Malignant and benign
   neoplasms
23 (2.6)
-
-
-
   NMSC
3 (0.3)
-
1 (0.7)
1 (0.2)
   Lymphoma
-
-
-
-
   Transitional cell
   Carcinoma
1 (0.1)
-
-
1 (0.2)
   IBD
-
-
-
-
   Gastrointestinal
   disorders other than
   IBD
92 (10.5)
-
-
-
   Acute TB during the
   study or reactivationc
-
-
-
-
   MACE
1 (0.1)d
1 (0.7)e
-
6 (1.1)f
   Thrombosis
-
-
-
2 (0.4)
   Cholecystitis chronic
-
1 (0.7)
-
-
   Suicidal behavior
-
1 (0.7)
-
-
   TEAE infections
366 (41.6)
-
-
-
      Severe infections
9 (1.0)
-
-
-
   Death
1 (0.1)g
-
-
1 (0.2)h
Abbreviations:AE, adverse event; COVID-19, Coronavirus Disease 2019; IBD, inflammatory bowel disease; LDD, long disease duration; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; nSR, nonsuper responder; q8w, every 8 weeks; q16w, every 16 weeks; SAE, serious adverse event; SDD, short disease duration; SOC, system organ class; SR, super responder; TB, tuberculosis; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.
aHypersensitivity pneumonitis.
bIncludes all cases of skin candida, oral candidiasis, esophageal candidiasis, balanitis candida, and candida infection.
cThere were 6 patients (total, 0.7%; SDD, n=2 [0.6%]; LDD, n=4 [0.8%]) with latent TB at baseline. There were no active cases of TB.
dCerebral infarction.
eMyocardial infarction.
fIncluded 5 cases of myocardial infarction and 1 case of cerebrovascular accident.
gReason was accidental asphyxiation and was not drug-related.
hCause of death unknown.

Part 3: Interim Analysis (Data through Week 116)

Schäkel et al (2023)7 presented the interim results (week 116) of part 3 of the GUIDE study that evaluated the maintenance of response in SRs after withdrawal from TREMFYA treatment at week 68 through week 220 and also the impact of early intervention on the treatment-free period. Asadullah et al (2024)8 evaluated the effects of TREMFYA withdrawal in SRs and subsequent response upon retreatment where disease control (PASI <3) was not maintained through week 116.

Results

Baseline Characteristics

Select Baseline Characteristics of SRs Withdrawn from TREMFYA Treatment and Retreated through Part 37,8
Characteristic
SRs Withdrawn from TREMFYA
(N=273)
SRs Retreated through Part 3 (Week 68-116)
(n=186)
SRs Remained in Withdrawal through Week 116
(n=74)
Mean disease duration, years
10.2
10.9
9.0
≤2 years (SDD), n
138
81
49
>2 years (LDD), n
135
105
25
Mean age, years
39.7
39.2
41.3
Female, %
31.5
72.0
40.5
Mean BMI, kg/m²
26.9
27.1
26.5
Mean PASI score
18.7
19.0
17.8
Mean DLQI score
18.9
18.4
19.9
Dosing in part 2, n (%)
   q8w
136 (49.8)
87 (46.8)
43 (58.1)
   q16w
137 (50.2)
99 (53.2)
31 (41.9)
Prior psoriasis therapy, n (%)
   Biologic naïve
252 (92.3)
170 (91.4)
70 (94.6)
   ≥1 biologic therapy
21 (7.7)
16 (8.6)
4 (5.4)
PASI 0 at week 68, n (%)
221 (81.0)
143 (76.9)
67 (91.0)
Abbreviations:BMI, body mass index; DLQI, Dermatology Life Quality Index; LDD, long disease duration; PASI, Psoriasis Area and Severity Index; q8w, every 8 weeks; q16w, every 16 weeks; SDD, short disease duration; SR, super responder.
Efficacy
  • Through week 116, SRs (n=273) had an overall median treatment-free duration of 302 days after withdrawal from TREMFYA treatment. No difference was observed in the median treatment-free duration between the 2 dosing groups (TREMFYA 100 mg q8w, 301 days; TREMFYA 100 mg q16w, 310 days; nominal P=0.480).7,8
    • Of the 273 SRs, 186 were retreated with TREMFYA (median treatment duration, 259 days), 74 remained treatment-free through week 116, and 13 discontinued or were lost to follow-up.8
  • At week 116, absolute PASI response rates among SRs withdrawn from TREMFYA treatment were similar irrespective of previous TREMFYA dosing, see Table: Proportion of SRs Achieving Absolute PASI Response at Week 116 per Previous TREMFYA Dosing (NRI).

Proportion of SRs Achieving Absolute PASI Response at Week 116 per Previous TREMFYA Dosing (NRI)7
3a: TREMFYA 100 mg q8wa
(n=136)
3b: TREMFYA 100 mg q16wa
(n=137)
Overall
(N=273)
Absolute PASI <3, %
22.8
19.0
20.9
P-Value
0.367b
-
Absolute PASI ≤1, %
15.4
10.9
13.2
P-Value
0.212b
-
Absolute PASI=0, %
9.6
7.4
8.4
P-Value
0.441b
-
PASI ≥5 is part of the retreatment criteria for group 3c.
Abbreviations: NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; q8w, every 8 weeks; q16w, every 16 weeks; SR, super responder.
aPatients in groups 3a and 3b previously received TREMFYA q8w and q16w, respectively, in part 2 of the study. The last injections for those who received TREMFYA q8w (3a) and q16w (3b) were at weeks 60 and 52, respectively.
bThese endpoints were not controlled for multiple comparisons. Therefore, the P-value is nominal.
  • A total of 74 (27.1%) patients remained treatment free through week 116, with a greater proportion of patients in the SDD (n=49 [66.2%]) vs LDD (n=25 [33.8%]) group.7
  • The median treatment-free duration was substantially longer in patients with SDD vs LDD (378 vs 259 days; P<0.001).7
  • Based on data from multivariable logistic regression, patients with SDD had a higher likelihood of being treatment free at week 116 (OR, 2.77; 95% CI, 1.53-5.11; P<0.001).7
    • Among SRs who received TREMFYA 100 mg q8w in part 2 of the study, the median treatment-free duration in those with SDD vs LDD was 398 vs 233 days (P<0.001).
  • At week 116, absolute PASI response rates among SRs who remained treatment free were greater in those with SDD vs LDD, see Table: Proportion of Patients Achieving Absolute PASI Response at Week 116 per PsO Disease Duration (OC).

Proportion of Patients Achieving Absolute PASI Response at Week 116 per PsO Disease Duration (OC)7
SDD (PsO Duration ≤2 Years)
(n=49)
LDD (PsO Duration >2 Years)
(n=25)
Overall
(N=74)
Absolute PASI <3, %
87.8
64.0
79.7
P-Value
0.016a
-
Absolute PASI ≤1, %
61.2
24.0
48.6
P-Value
0.002a
-
Absolute PASI=0, %
38.8
16.0
31.1
P-Value
0.045a
-
PASI ≥5 is part of the retreatment criteria for group 3c.
Abbreviations: LDD, long disease duration; OC, observed case; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; q8w, every 8 weeks; q16w, every 16 weeks; SDD, short disease duration.
aNominal P-value <0.05 for SDD vs LDD. The endpoints were not controlled for multiple comparisons. Therefore, the P-value is nominal, and statistical significance has not been established.

Proportion of SRs Achieving Absolute PASI Response After Retreatment with TREMFYA in Overall Retreated Patients and Those with Prior Dosing in Part 2 (NRI)8
Retreatment at Week 8
Retreatment at Week 16
Retreatment at Week 24
Overall retreated patients
n=186
   Absolute PASI <3, %
75.8
87.1
92.5
   Absolute PASI ≤1, %
41.4
66.1
78.5
   Absolute PASI=0, %
21.0
46.2
58.1
Patients with prior q8w dosing in Part 2
n=87
   Absolute PASI <3, %
78.2
86.2
95.4
   Absolute PASI ≤1, %
43.7
66.7
80.5
   Absolute PASI=0, %
19.5
47.1
57.5
Retreatment phase in part 3 does not include an induction scheme, ie, the retreatment dosing interval was q8w.
Abbreviations: NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; q8w, every 8 weeks; SR, super responder.

Proportion of SRs Achieving Absolute PASI Response at Retreatment Week 24 with TREMFYA per Previous Dosing Interval and Baseline Body Weight (NRI)8
By Previous Dosing Interval
By Baseline Body Weight
Part 2: TREMFYA 100 mg q8w
(n=87)
Part 2: TREMFYA 100 mg q16w
(n=99)
≤90 Kg
(n=132)
>90 Kg
(n=54)
Absolute PASI <3, %
95.4
89.9
92.4
92.6
P-Value
0.144a
0.968a
Absolute PASI=0, %
57.5
58.6
59.1
55.6
P-Value
0.878a
0.659a
Patients with PASI >5 during withdrawal phase were retreated with TREMFYA at retreatment weeks 0, 8, and 16.
Abbreviations: NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; q8w, every 8 weeks; q16w, every 16 weeks; SR, super responder.
aThese endpoints were not controlled for multiple comparisons. Therefore, the P-value is nominal.
  • At retreatment week 0, mean PASI was 7.3 and DLQI score was 11.2. Both mean PASI and DLQI decreased over time with TREMFYA retreatment as shown in Table: Mean PASI and DLQI After TREMFYA Retreatment through Week 116.
  • At retreatment week 0 (n=178), Psoriasis Symptoms and Signs Diary (PSSD) item scores were 6.0, 4.7, 3.8 and 4.1 for Question 1 (Q1; itch), Q9 (burning), Q10 (stinging), and Q11 (pain from lesions).8
  • At retreatment week 24, the mean PSSD Q1, Q9, Q10, and Q11 scores were 1.0 (n=174), 0.4 (n=175), 0.3 (n=175), and 0.3 (n=175), respectively.8

Mean PASI and DLQI through Week 116 After TREMFYA Retreatment through Week 1168
Retreatment at Week 8
Retreatment at Week 16
Retreatment at Week 24
n=184
n=172
n=180
Mean PASI
1.8
0.8
0.5
n=3
n=171
n=180
Mean overall DLQI
3.0
1.5
1.4
-
n=171
n=180
Mean DLQI Q1 (itchy, sore, painful, or stinging skin)
-
0.5
0.4
Data prior to week 68 were not considered. Patients with PASI >5 during withdrawal phase were retreated with TREMFYA at retreatment weeks 0, 8, and 16.
Abbreviations: DLQI, Dermatology Life Quality Index; OC, observed cases; PASI, Psoriasis Area and Severity Index; PSSD, Psoriasis Symptoms and Signs Diary; Q, Question.

PASI Response Over Time After Retreatment with TREMFYA in Patients with PASI=0 vs PASI >0 at Week 688
Retreatment
Week 8
Retreatment
Week 16
Retreatment
Week 24
Mean PASI (OC)
n=42
n=36
n=41
   Mean PASI >0
2.4
1.4
1.1
n=141
n=135
n=138
   Mean PASI=0
1.6
0.6
0.3
PASI=0 After Initiating Retreatment (NRI), %
n=42
n=42
n=42
   PASI >0
9.5
21.4
31.0a
n=143
n=143
n=143
   PASI=0
24.5
53.8
66.4a
Patients with PASI >5 during withdrawal phase were retreated with TREMFYA at retreatment weeks 0, 8, and 16.
Abbreviations: NRI, nonresponder imputation; OC, observed cases; PASI, Psoriasis Area and Severity Index.
aNominal P-value <0.001 for PASI >0 vs PASI=0 groups at week 24. The endpoints were not controlled for multiple comparisons. Therefore, the P-value is nominal, and statistical significance has not been established.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 09 March 2024.

 

References

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3 Schäkel K, Asadullah K, Pinter A, et al. Prolonged q16w treatment interval of guselkumab is non-inferior to q8w dosing for maintaining disease control in super responders: primary results from GUIDE at Week 68 in patients with psoriasis. Poster presented at: ESDR congress; September 28-October 1, 2022; Amsterdam, the Netherlands.  
4 Schäkel K, Reich K, Asadullah K, et al. Prognostic factors for early PASI 100 response in psoriasis patients treated with guselkumab: results from the GUIDE study. Poster presented at: AAD annual meeting; March 25-29, 2022; Boston, MA.  
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6 Schäkel K, Reich K, Asadullah K, et al. Early disease intervention with guselkumab in psoriasis leads to a higher rate of stable complete skin clearance ('clinical super response’): week 28 results from the ongoing phase IIIb randomized, double-blind, parallel-group, GUIDE study. J Eur Acad Dermatol Venereol. 2023;37(10):2016-2027.  
7 Schäkel K, Asadullah K, Pinter A, et al. Treatment-free period of more than 1 year in guselkumab super responders with short disease duration of psoriasis: withdrawal data from the GUIDE trial. Oral Presentation presented at: European Academy of Dermatology and Venereology 2023; October 11-14, 2023; Berlin, Germany.  
8 Asadullah K, Schäkel K, Pinter A, et al. GUIDE trial (part 3): following guselkumab withdrawal and a long treatment-free period, disease control is rapidly regained upon re-treatment in psoriasis super responders. Oral Presentation presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.  
9 Janssen-Cilag G.m.b.H. A study to evaluate further therapeutic strategies with guselkumab in participants with moderate-to-severe plaque-type psoriasis (GUIDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2023 April 24]. Available from: https://clinicaltrials.gov/study/NCT03818035 NLM Identifier: NCT03818035.  
10 Schäkel K, Reich K, Asadullah K, et al. Supplement to: Early disease intervention with guselkumab in psoriasis leads to a higher rate of stable complete skin clearance ('clinical super response’): week 28 results from the ongoing phase IIIb randomized, double-blind, parallel-group, GUIDE study. J Eur Acad Dermatol Venereol. 2023;37(10):2016-2027.