Overview1
Phase 3, multicenter, randomized, double-blind
PBO- and active comparator-controlled study (N=837) that evaluated the efficacy and safety
of TREMFYA compared with PBO and ADA in patients with moderate to severe plaque PsO
Select Eligibility Criteria1,2
Select Inclusion Criteria
- Adults with plaque PsO ≥6 months who were candidates for phototherapy or systemic therapy were eligible for enrollment
- Baseline IGA score ≥3
- PASI score ≥12
- ≥10% BSA involvement
Select Exclusion Criteria
- Patients with guttate, erythrodermic, pustular, or drug-induced PsO2
- Patients with a history or symptoms of active tuberculosis
Study Design1,3
OLE through 5 yearsa: After week 48, patients initially randomized to TREMFYA or PBO continued TREMFYA q8w starting at week 52 through the OLE; patients initially randomized to ADA started TREMFYA at week 52 and then q8w thereafter
Coprimary and Other
Efficacy Endpoints1,3
At Week 16, an IGA 0/1 and PASI 90 rates were achieved by significantly more TREMFYA vs PBO patients (P<0.001)
At Week 252 (OLE):
- In the combined TREMFYA group (N=391), PASI 90 and IGA 0/1 score analyzed using TFR were observed in 84.1% and 82.4% of patients, respectively
Select Secondary
Efficacy Endpoints1
| TREMFYA 100 mg (N=329) |
ADA 40 mg (N=334) |
|
|---|---|---|
| Week 16 | ||
| IGA 0/1 | 85.1% | 65.9% |
| PASI 75 | 91.2% | 73.1% |
| PASI 90 | 73.3% | 49.7% |
| Week 24 | ||
| IGA 0 | 52.6% | 29.3% |
| IGA 0/1 | 84.2% | 61.7% |
| PASI 90 | 80.2% | 53.0% |
| Week 48 | ||
| IGA 0 | 50.5% | 25.7% |
| IGA 0/1 | 80.5% | 55.4% |
| PASI 90 | 76.3% | 47.9% |
Safety1,3
Through Week 16:
- The proportion of patients with ≥1 AE was comparable across the treatment groups (PBO, 49.4%; TREMFYA, 51.7%; ADA, 51.1%)
- SAEs were reported in 1.7%, 2.4%, and 1.8% of PBO-, TREMFYA-, and ADA-treated patients, respectively
Through Week 264 (OLE):
- The proportion of patients with ≥1 AE in the all TREMFYA (N=774), combined TREMFYA (N=494) and ADA to TREMFYA (N=280) groups were 87.7%, 89.5% and 84.6%, respectively
- SAEs (≥1) were reported in 16.4%, 19.2%, and 11.4% of patients in the all TREMFYA, combined TREMFYA and ADA to TREMFYA groups, respectively
Note: Before week 48, patients who discontinued study agent because of lack of efficacy or an AE of PsO worsening or who started a protocol-prohibited PsO treatment were considered nonresponders (binary endpoints) or had baseline values carried over (continuous endpoints). Other patients with missing data were considered nonresponders for binary endpoints (nonresponder imputation) and had last observation carried forward for continuous endpoints.
Abbreviations: ADA, adalimumab; AE, adverse event; BSA,
body surface area; IGA, Investigator’s Global Assessment; OLE, open-label extension; PASI 75/90,
≥75%/90% improvement in Psoriasis Area and Severity Index score from baseline; PBO, placebo;
PsO, psoriasis; q2w, every 2 weeks; q8w, every 8 weeks; R, randomization; SAE, serious adverse
event; TFR, treatment failure rules.
aThrough 252 weeks for efficacy and 264 weeks for safety.
VOYAGE 1 is a phase 3, multicenter, randomized, double-blind, PBO- and active comparator-controlled study that evaluated the efficacy and safety of TREMFYA compared with PBO and ADA in patients with moderate to severe plaque PsO. The study was conducted at 101 global sites from December 2014 through April 2016.1
Select Inclusion Criteria1
- Patients (≥18 years of age) with a diagnosis of plaque PsO for ≥6 months who were candidates for phototherapy or systemic therapy
- Baseline IGA score ≥3
- PASI score ≥12
- BSA involvement of ≥10%
Select Exclusion Criteria2
- Patients with guttate, erythrodermic, pustular, or drug-induced PsO
Eligible patients (N=837) were randomized 2:1:2 to 1 of 3 treatment arms (TREMFYA [n=329], PBO [n=174] or ADA [n=334]). After week 48, patients initially randomized to TREMFYA or PBO at week 0 continued to receive TREMFYA 100 mg q8w starting at week 52 through the OLE period. Patients initially randomized to ADA entered a washout period after their final dose of ADA at week 47 and initiated TREMFYA 100 mg at week 52 and then continued q8w thereafter.1,2
VOYAGE 1 Study Design Through 264 Weeks1,3,a
aTo maintain blinding, both TREMFYA and ADA placebos were administered as necessary.
bProportion of patients achieving an IGA score of cleared/minimal disease (IGA 0/1) and PASI 90 at week 16 in the TREMFYA vs PBO group.
cThe last dose of TREMFYA was administered at week 252; efficacy was evaluated through week 252.
dSafety was evaluated through week 264.
Coprimary Endpoints1
- Proportion of patients achieving an IGA score of cleared (0) or minimal (1) disease and the proportion of patients who achieved a PASI 90 response at week 16 in the TREMFYA group compared to PBO group.
Major Secondary Endpointsa,1
| TREMFYA
vs PBO |
TREMFYA
vs ADA |
Study visit | |
|---|---|---|---|
| Proportion of patients who achieve IGA 0 | - | x | Week 24 |
| Proportion of patients who achieve IGA 0/1 | - | x | Week 24 |
| Proportion of patients who achieve PASI 90 | - | x | Week 24 |
| Proportion of patients who achieve IGA 0 | - | x | Week 48 |
| Proportion of patients who achieve IGA 0/1 | - | x | Week 48 |
| Proportion of patients who achieve PASI 90 | - | x | Week 48 |
| Change from baseline in DLQI score | x | - | Week 16 |
| Proportion of patients who achieve IGA 0/1b,c | - | x | Week 16 |
| Proportion of patients who achieve PASI 90b,c | - | x | Week 16 |
| Proportion of patients who achieve PASI 75b,c | - | x | Week 16 |
| Proportion of patients who achieve ss-IGA 0/1d | x | - | Week 16 |
| Change from baseline in PSSD symptom score | x | - | Week 16 |
| Proportion of patients who achieved PSSD symptom score 0e | - | x | Week 24 |
|
“x” indicates major secondary endpoint was measured against listed
comparator at listed study visit and "-" indicates major secondary endpoint was
not measured against listed comparator at listed study visit. aTo control the overall type 1 error rate, the primary analysis and major secondary analyses were tested using a fixed sequence method. bTested for noninferiority of the TREMFYA group compared to adalimumab group. cTested for superiority of the TREMFYA group compared with the adalimumab group. dIncluded only randomized patients with scalp psoriasis who had an ss-IGA score ≥2 at baseline and who achieved ≥2-grade improvement. eIncluded only randomized patients with PSSD symptom score ≥1 at baseline. |
|||
- Safety was monitored throughout the study.1
- Demographic and disease characteristics were comparable across treatment groups at baseline.1
Demographic and Disease Characteristics1
|
TREMFYA (N=329) |
ADA (N=334) |
PBO (N=174) |
Total
(N=837) |
|
|---|---|---|---|---|
| Age, years, mean (±SD) | 43.9 (±12.74) | 42.9 (±12.58) | 44.9 (±12.90) | 43.7 (±12.72) |
| Men, n (%) | 240 (72.9) | 249 (74.6) | 119 (68.4) | 608 (72.6) |
| Race, n (%) | ||||
| White | 262 (79.6) | 277 (82.9) | 145 (83.3) | 684 (81.7) |
| Asian | 51 (15.5) | 47 (14.1) | 23 (13.2) | 121 (14.5) |
| Black | 6 (1.8) | 8 (2.4) | 3 (1.7) | 17 (2.0) |
| BMI, kg/m2, mean (±SD) | 29.7 (±6.22) | 29.8 (±6.48) | 28.9 (±6.89) | 29.6 (±6.47) |
| Duration of PsO, years, mean (±SD) | 17.9 (±12.27) | 17.0 (±11.27) | 17.6 (±12.44) | 17.5 (±11.91) |
| BSA involvement, %, mean (±SD) | 28.3 (±17.10) | 28.6 (±16.66) | 25.8 (±15.93) | 27.9 (±16.70) |
| IGA score 0-4, n (%) | ||||
| Mild, 2 | 0 | 3 (0.9) | 0 | 3 (0.4) |
| Moderate, 3 | 252 (76.6) | 241 (72.2) | 131 (75.3) | 624 (74.6) |
| Severe, 4 | 77 (23.4) | 90 (26.9) | 43 (24.7) | 210 (25.1) |
| PASI score 0-72, mean (±SD) | 22.1 (±9.49) | 22.4 (±8.97) | 20.4 (±8.74) | 21.9 (±9.15) |
| DLQI score 0-30, n | 322 | 328 | 170 | 820 |
| Mean (±SD) | 14.0 (±7.48) | 14.4 (±7.29) | 13.3 (±7.12) | 14.0 (±7.33) |
| PSSD score 0-100, n | 249 | 274 | 129 | 652 |
| Mean symptom score (±SD) | 54.4 (±24.63) | 53.9 (±25.79) | 48.3 (±23.77) | 53.0 (±25.03) |
| Mean sign score (±SD) | 56.9 (±21.30) | 58.5 (±21.73) | 53.6 (±20.34) | 56.9 (±21.34) |
| Psoriatic arthritis, n (%) | 64 (19.5) | 62 (18.6) | 30 (17.2) | 156 (18.6) |
| Prior treatments, n (%) | ||||
| Topical agents | 299 (90.9) | 309 (92.8) | 154 (88.5) | 762 (91.1) |
| Phototherapy | 188 (57.3) | 180 (53.9) | 86 (49.4) | 454 (54.3) |
| Conventional systemic agents | 210 (63.8) | 215 (64.4) | 92 (52.9) | 517 (61.8) |
| Biologic agents | 71 (21.6) | 70 (21.0) | 34 (19.5) | 175 (20.9) |
- Treatment discontinuation through week 48 occurred in 6.9% (12 of 174), 8.5% (28 of 329), and 15.6% (52 of 334) of patients in the PBO, TREMFYA, and ADA groups, respectively.1
- At week 16, the coprimary endpoints of IGA score of 0 or 1 and PASI 90 were achieved by significantly more patients in the TREMFYA vs PBO group (P<0.001 each).1
IGA 0/1 and PASI 90 Response Rates at Week 161
- TREMFYA was superior to PBO and/or ADA for all major secondary endpoints (P<0.001 for all).1
IGA and PASI Response Rates at Weeks 16, 24, and 481
|
TREMFYA 100 mg (n=329) |
ADA
40 mg (n=334) |
PBO
(n=174) |
|
|---|---|---|---|
| Week 16 | |||
| IGA 0a | 47.7%; n=157; P<0.001 | 26.3%; n=88 | 1.1%; n=2 |
| IGA 0/1a,b | 85.1%; n=280; P<0.001 | 65.9%; n=220 | 6.9%; n=12 |
| PASI 75 | 91.2%; n=300; P<0.001 | 73.1%; n=244 | 5.7%; n=10 |
| PASI 90 | 73.3%; n=241; P<0.001 | 49.7%; n=166 | 2.9%; n=5 |
| PASI 100 | 37.4%; n=123; P<0.001 | 17.1%; n=57 | 0.6%; n=1 |
| Week 24 | |||
| IGA 0a | 52.6%; n=173; P<0.001 | 29.3%; n=98 | - |
| IGA 0/1a,b | 84.2%; n=277; P<0.001 | 61.7%; n=206 | - |
| PASI 75 | 91.2%; n=300; P<0.001 | 72.2%; n=241 | - |
| PASI 90 | 80.2%; n=264; P<0.001 | 53.0%; n=177 | - |
| PASI 100 | 44.4%; n=146; P<0.001 | 24.9%; n=83 | - |
| Week 48 | |||
| IGA 0a | 50.5%; n=166; P<0.001 | 25.7%; n=86 | - |
| IGA 0/1a,b | 80.5%; n=265; P<0.001 | 55.4%; n=185 | - |
| PASI 75 | 87.8%; n=289; P<0.001 | 62.6%; n=209 | - |
| PASI 90 | 76.3%; n=251; P<0.001 | 47.9%; n=160 | - |
| PASI 100 | 47.4%; n=156; P<0.001 | 23.4%; n=78 | - |
|
aIGA 0 = cleared disease. bIGA 1 = minimal disease. |
- TREMFYA was superior to PBO and/or ADA for all major secondary endpoints (P<0.001 for all).1
- At week 16, the improvement from baseline in DLQI score was significantly greater for TREMFYA-treated patients compared with PBO-treated patients (mean change -11.2 vs -0.6, P<0.001).1
- The changes in PSSD symptom score and sign score at week 16 for TREMFYA-treated patients and PBO-treated patients were -41.9±24.61 and -3.0±19.56 for symptom score (P<0.001) and -44.6±22.00 and -4.1±17.87 for sign score, respectively.1
- At week 24, a DLQI score of 0 or 1 was achieved by 60.9% (195/320) of TREMFYA-treated patients and 39.5% (126/319) of ADA-treated patients. Similar results were seen at week 48 (62.5% [200/320] vs 38.9% [124/319]).1
- For patients with a baseline PSSD ≥1, the proportion of patients who achieved a PSSD of 0 at week 24 was 36.3% (90/248) for the TREMFYA group and 21.6% (59/273) for the ADA group (P<0.001).1
- Through weeks 16 (placebo-controlled period) and 48, the proportions of patients with at least 1 AE, AEs leading to treatment discontinuation, and at least 1 SAE were comparable across treatment groups.1
Adverse Events Through Week 481
| Through Week 16 | Through Week 48 | ||||
|---|---|---|---|---|---|
|
TREMFYA (N=329) |
ADA (N=333) |
PBO (N=174) |
TREMFYA
(N=329) |
ADA (N=333) |
|
| Mean duration of follow-up, week | 16.27 | 16.14 | 15.88 | 46.47 | 45.56 |
| ≥1 AE, n (%) | 170 (51.7) | 170 (51.1) | 86 (49.4) | 243 (73.9) | 248 (74.5) |
| Most common AEs (occurring in ≥5% of patients in any group), n (%) | |||||
| Nasopharyngitis | 30 (9.1) | 35 (10.5) | 17 (9.8) | 83 (25.2) | 74 (22.2) |
| Upper respiratory tract infection | 25 (7.6) | 16 (4.8) | 9 (5.2) | 47 (14.3) | 42 (12.6) |
| Injection-site erythema | 6 (1.8) | 15 (4.5) | 1 (0.6) | 8 (2.4) | 22 (6.6) |
| Headache | 12 (3.6) | 13 (3.9) | 7 (4.0) | 18 (5.5) | 25 (7.5) |
| Arthralgia | 11 (3.3) | 9 (2.7) | 3 (1.7) | 18 (5.5) | 16 (4.8) |
| Pruritus | 5 (1.5) | 7 (2.1) | 10 (5.7) | 8 (2.4) | 12 (3.6) |
| Back pain | 6 (1.8) | 4 (1.2) | 2 (1.1) | 12 (3.6) | 17 (5.1) |
| Discontinued treatment due to AE, n (%) | 4 (1.2) | 3 (0.9) | 2 (1.1) | 9 (2.7) | 12 (3.6) |
| ≥1 SAEs, n (%) | 8 (2.4) | 6 (1.8) | 3 (1.7) | 16 (4.9) | 15 (4.5) |
| Infections, n (%) | 85 (25.8) | 85 (25.5) | 44 (25.3) | 172 (52.3) | 167 (50.2) |
| Requiring treatment | 20 (6.1) | 24 (7.2) | 13 (7.5) | 54 (16.4) | 60 (18.0) |
| Serious infections | 0 | 2 (0.6) | 0 | 2 (0.6) | 3 (0.9) |
| Malignancies, n (%) | 0 | 0 | 0 | 2a (0.6) | 0 |
| NMSCb, n (%) | 1 (0.3) | 0 | 0 | 2 (0.6) | 1 (0.3) |
| MACEc, n (%) | 1 (0.3) | 1 (0.3) | 0 | 1 (0.3) | 1 (0.3) |
|
aIncludes malignancies other than NMSC (i.e. prostate and breast
cancer). bIncludes 3 basal cell carcinomas. cIncludes sudden cardiac death, myocardial infarction, and stroke. |
|||||
- Through week 48, ISRs occurred in 2.2% of TREMFYA-treated patients and in 9.0% of ADA-treated patients. Most ISRs were mild.1
- Antibodies to guselkumab were detected in 5.3% (26/492) of patients through week 44, with titers being generally low (81% ≤1:320). The occurrence of ISRs was not observed to be related to antibody development.1
- The VOYAGE 1 OLE evaluated the long-term efficacy and safety of TREMFYA for the treatment of moderate to severe plaque PsO in patients receiving treatment with TREMFYA through 5 years (week 264).3,4
- For information regarding the study design of VOYAGE 1 including its OLE, refer to image: VOYAGE 1 Study Design Through 264 weeks.
- For the week 264 OLE analysis, data are presented as defined below:3
- The randomized to TREMFYA group (n=329) included patients randomized to TREMFYA at baseline.
- The combined TREMFYA group (n=494) included patients randomized to TREMFYA at baseline (n=329) and those randomized to PBO at baseline who crossed over to TREMFYA at week 16 (n=165).
- The ADA→TREMFYA group (n=280) included patients randomized to ADA at baseline who crossed over to receive TREMFYA at week 52.
- Efficacy endpoints were analyzed up to week 252 using different
methodologies:3
- Prespecified TFR defined patients as nonresponders if discontinuation occurred due to lack of efficacy, worsening of PsO, or use of a protocol-prohibited PsO treatment.
- NRI defined patients as nonresponders if efficacy data were missing after application of TFR.
- As OBS included patients with data from each visit with missing data not imputed.
- Safety was assessed through week 264.3,5
- The all TREMFYA group (n=774) included patients in the combined TREMFYA group and ADA→TREMFYA group as defined above.
- Refer to table: Demographics and Disease Characteristics for VOYAGE 1 baseline patient characteristics.
- Overall, 19.6% (152/774) of patients discontinued the study agent from baseline (for those originally randomized to TREMFYA) and from the time of crossover to TREMFYA (for those originally randomized to placebo or adalimumab) through week 252.4
- PASI 90 and PASI 100 responses from week 52 through week 252 are reported in table: Proportion of Patients who Achieved PASI 90 or PASI 100 Response.
Proportion of Patients who Achieved PASI 90 or PASI 100 Response3
| TFRa | NRI | OBS | |||||
|---|---|---|---|---|---|---|---|
|
Combined TREMFYAb |
TREMFYA at baselinec |
Combined TREMFYAb |
TREMFYA at baselinec |
TREMFYA at baselinec |
TREMFYA at baselinec |
||
| Week 52 | n=468 | n=307 | n=494 | n=329 | n=463 | n=302 | |
| PASI 90 | 79.7% | 80.1% | 75.5% | 74.8% | 80.6% | 81.5% | |
| PASI 100 | 49.1% | 50.5% | 46.6% | 47.1% | 49.7% | 51.3% | |
| Week 100 | n=448 | n=290 | n=494 | n=329 | n=442 | n=284 | |
| PASI 90 | 82.1% | 82.1% | 74.5% | 72.3% | 83.3% | 83.8% | |
| PASI 100 | 51.1% | 49.0% | 46.4% | 43.2% | 51.8% | 50.0% | |
| Week 156 | n=432 | n=280 | n=494 | n=329 | n=425 | n=274 | |
| PASI 90 | 82.9% | 80.0% | 72.5% | 68.1% | 84.0% | 81.8% | |
| PASI 100 | 50.9% | 48.9% | 44.5% | 41.6% | 51.8% | 50.0% | |
| Week 204 | n=411 | n=264 | n=494 | n=329 | n=401 | n=256 | |
| PASI 90 | 82.2% | 81.8% | 68.4% | 65.7% | 84.3% | 84.4% | |
| PASI 100 | 55.7% | 53.4% | 46.4% | 42.9% | 57.1% | 55.1% | |
| Week 252 | n=391 | n=255 | n=494 | n=329 | n=380 | n=246 | |
| PASI 90 | 84.1% | 83.1% | 66.6% | 64.4% | 86.6% | 86.2% | |
| PASI 100 | 52.7% | 51.0% | 41.7% | 39.5% | 54.2% | 52.8% | |
|
aEfficacy PASI 90 and PASI 100 reported in the randomized
TREMFYA at baseline group were analyzed using NRI through week 48, then
TFR beyond week 48. |
|||||||
- IGA 0/1 and IGA 0 responses from week 52 through week 252 are reported in table: Proportion of Patients who Achieved IGA 0/1 or IGA 0 Scores.
Proportion of Patients who Achieved IGA 0/1 or IGA 0 Scores3
| TFRa | NRI | OBS | |||||
|---|---|---|---|---|---|---|---|
| Combined
TREMFYAb |
TREMFYA at baselinec |
Combined TREMFYAb |
TREMFYA at baselinec |
TREMFYA at baselinec |
TREMFYA at baselinec |
||
| Week 52 | n=468 | n=307 | n=494 | n=329 | n=463 | n=302 | |
| IGA 0/1 | 84.6% | 82.7% | 80.2% | 77.2% | 85.5% | 84.1% | |
| IGA 0 | 53.6% | 53.7% | 50.8% | 50.2% | 54.2% | 54.6% | |
| Week 100 | n=448 | n=290 | n=494 | n=329 | n=442 | n=284 | |
| IGA 0/1 | 83.3% | 82.4% | 75.5% | 72.6% | 84.4% | 84.2% | |
| IGA 0 | 55.6% | 53.8% | 50.4% | 47.4% | 56.3% | 54.9% | |
| Week 156 | n=430 | n=278 | n=494 | n=329 | n=423 | n=272 | |
| IGA 0/1 | 82.1% | 80.6% | 71.5% | 68.1% | 83.5% | 82.4% | |
| IGA 0 | 53.3% | 51.4% | 46.4% | 43.5% | 54.1% | 52.6% | |
| Week 204 | n=410 | n=263 | n=494 | n=329 | n=400 | n=255 | |
| IGA 0/1 | 81.7% | 79.8% | 67.8% | 63.8% | 83.8% | 82.4% | |
| IGA 0 | 57.1% | 55.1% | 47.4% | 44.1% | 58.5% | 56.9% | |
| Week 252 | n=391 | n=255 | n=494 | n=329 | n=380 | n=246 | |
| IGA 0/1 | 82.4% | 81.2% | 65.2% | 62.9% | 84.7% | 84.1% | |
| IGA 0 | 54.7% | 53.7% | 43.3% | 41.6% | 56.3% | 55.7% | |
|
aEfficacy IGA 0/1 and IGA 0 reported in the randomized
TREMFYA at baseline group were analyzed using NRI through week 48, then
TFR beyond week 48. |
|||||||
- At week 100, among patients in the combined TREMFYA group4:
- The proportion of patients achieving DLQI 0/1 was 75.2% (n=436).
- The proportion of patients achieving a PSSD symptom score of 0 was 40.2% (n=343).
- The proportion of patients achieving a PSSD sign score of 0 was 32.9% (n=343).
- Comparable responses were observed in the ADA→TREMFYA group as well.
- At week 252, among patients in the combined TREMFYA and ADA→TREMFYA
group4:
- The proportions of patients achieving DLQI 0/1 were 72.7% (n=374) and 74.0% (n=235), respectively.
- The proportions of patients achieving a PSSD symptom score of 0 were 42.4% (n=297) and 48.0% (n=200), respectively.
- The proportions of patients achieving a PSSD sign score of 0 were 33.0% (n=297) and 37.8% (n=201), respectively.
- No cases of IBD, active tuberculosis, opportunistic infections, anaphylactic or serum sickness-like reactions were reported.3
- CTCAE grade ≥2 in blood hematology and chemistry laboratory values were uncommon.2
Adverse Events Through Week 2643
| Combined TREMFYAa | ADA→ TREMFYAb | All TREMFYAc | |
|---|---|---|---|
| Treated patients, n | 494 | 280 | 774 |
| Average duration of follow-up, weeks | 226.4 | 199.0 | 216.5 |
| ≥1 AE, n (%) | 442 (89.5%) | 237 (84.6%) | 679 (87.7%) |
| Discontinuation due to ≥AE, n (%) | 33 (6.7%) | 14 (5.0%) | 47 (6.1%) |
| ≥1 SAE, n (%) | 95 (19.2%) | 32 (11.4%) | 127 (16.4%) |
| Infections, n (%) | 357 (72.3%) | 190 (67.9%) | 547 (70.7%) |
| Infections requiring treatment | 188 (38.1%) | 101 (36.1%) | 289 (37.3%) |
| Serious infections | 18 (3.6%) | 4 (1.4%) | 22 (2.8%) |
| Malignancies, n (%) | |||
| NMSC | 9 (1.8%) | 4 (1.4%) | 13 (1.7%) |
| Other than NMSCd | 15 (3.0%) | 3 (1.1%) | 18 (2.3%) |
| MACE, n (%) | 6 (1.2%) | 2 (0.7%) | 8 (1.0%) |
| Suicidal ideation and behavior, n (%) | 3 (0.6%) | 2 (0.7%) | 5 (0.6%) |
| Deaths, n (%) | 4 (0.8%) | 1 (0.4%) | 5 (0.6%) |
|
aIncludes patients randomized to TREMFYA at baseline and those
randomized to PBO who crossed over to TREMFYA at week 16. bIncludes patients randomized to ADA at baseline who crossed over to TREMFYA at week 52. cIncludes the combined TREMFYA and ADA→TREMFYA groups. dIncludes 4 colorectal cancers, 3 breast cancers, 2 each of head and neck cancer, melanoma, and prostate cancer, and 1 each bladder cancer, brain cancer, lymphoma, stomach cancer and sarcoma. |
|||
| AE | Adverse event | OBS | Observation |
|---|---|---|---|
| ADA | Adalimumab | OLE | Open-label extension |
| BSA | Body surface area | PASI 75/90/100 |
≥75%, ≥90% or ≥100% improvement in Psoriasis Area and Severity Index score from baseline |
| CTCAE | Common Terminology Criteria for Adverse Events | PSSD | Psoriasis Symptoms and Signs Diary |
| BMI | Body mass index | PBO | Placebo |
| DBL | Database lock | PsO | Psoriasis |
| DLQI | Dermatology Life Quality Index | q2w | Every 2 weeks |
| HRQoL | Health-related quality of life | q8w | Every 8 weeks |
| IGA 0/1 | Investigator’s Global Assessment cleared/minimal (IGA 0, cleared; IGA 1, minimal) | R | Randomization |
| IBD | Inflammatory bowel disease | SE | Secondary endpoint |
| ISR | Injection site reactions | SAE | Serious adverse event |
| MI | Myocardial infarction | SD | Standard deviation |
| MACE | Major adverse cardiovascular event | TFR | Treatment failure rules |
| NRI | Nonresponder imputation | US | United States |
| NMSC | Nonmelanoma skin cancer |
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 29 August 2024.
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