(guselkumab)
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TREMFYA® (guselkumab)
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Occurrence of Arthralgia in the Treatment of Adult Patients with Plaque Psoriasis
Last Updated: 05/16/2025
SUMMARY
- Please refer to the local labeling for relevant information regarding TREMFYA and the occurrence of arthralgia.
- Data included in this response are from the following phase 3 clinical trials of TREMFYA in patients with moderate to severe plaque psoriasis (PsO): VOYAGE 1, VOYAGE 2, ECLIPSE, and NAVIGATE.1
– 8 - In addition, the occurrence of arthralgia in patients receiving TREMFYA from retrospective studies is summarized below.9
, 10
CLINICAL DATA ON Moderate to Severe plaque PsO
VOYAGE 1
Blauvelt et al (2017)1 evaluated the efficacy and safety of TREMFYA compared to placebo and adalimumab through week 48 in patients with moderate to severe plaque PsO.
- The incidence of arthralgia events in patients treated with TREMFYA from the VOYAGE 1 study through week 48 is included in the following Table: Incidence of Arthralgia through Week 48 - VOYAGE 1.
| Adverse Event, n (%) | Weeks 0-16 PBO-Controlled Period | Weeks 0-48 Active Comparator-Controlled Period | Weeks 16-48 | |||
|---|---|---|---|---|---|---|
| PBO (n=174) | TREMFYA (n=329) | ADA (n=333) | TREMFYA (n=329) | ADA (n=333) | PBO→TREMFYA (n=165) | |
| Arthralgia | 3 (1.7) | 11 (3.3) | 9 (2.7) | 18 (5.5) | 16 (4.8) | 2 (1.2) |
| Abbreviation: ADA, adalimumab; PBO, placebo. | ||||||
VOYAGE 2
Reich et al (2017)2
- The incidence of arthralgia events in patients treated with TREMFYA from the VOYAGE 2 study through week 48 is included in the following Table: Incidence of Arthralgia through Week 48 - VOYAGE 2
.
| Adverse Event, n (%) | Weeks 0-16 PBO-Controlled Period | Weeks 0-28 Active Comparator-Controlled Period | Weeks 28-48 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PBO (n=248) | TREMFYA (n=494) | ADA (n=248) | PBO→ TREMFYAa | ADA (n=248) | TREMFYA (n=494) | PBO→ TREMFYAa (n=233) | TREMFYA (n=494) | ADA→ TREMFYAb | ADA (n=248) | |
| Arthralgia | 6 (2.4) | 11 (2.2) | 2 (0.8) | 0 | 18 (3.6) | 8 (3.2) | 4 (1.7) | 26 (5.3) | 3 (2.1) | 11 (4.4) |
| Abbreviation: ADA, adalimumab; PBO, placebo. aPBO crossover patients were included in the PBO→TREMFYA column after crossover to TREMFYA. bADA crossover patients were included in the ADA→TREMFYA column after crossover to TREMFYA at or after week 28. | ||||||||||
Pooled Safety Analysis - VOYAGE 1 and VOYAGE 2
Blauvelt et al (2022)4
The incidence of arthralgia in patients treated with TREMFYA from the pooled VOYAGE 1 and VOYAGE 2 studies through week 264 (5 years) is included in the following Table: Incidence of Arthralgia through Week 264 from the Pooled VOYAGE 1 and VOYAGE 2 Safety Analysis.
| Adverse Event, n (%) | TREMFYAa (n=1221) | Adalimumab → TREMFYA (n=500) | Combined TREMFYA (n=1721) |
|---|---|---|---|
| Arthralgia | 128 (10.5) | 45 (9.0) | 173 (10.1) |
| aPlacebo crossover patients were included in the TREMFYA column after crossover to TREMFYA. | |||
ECLIPSE
Reich et al (2019)6
- The incidence of arthralgia events in patients treated with TREMFYA from the ECLIPSE study through week 56 is included in the following Table: Incidence of Arthralgia through Week 56
from the ECLIPSE Trial.
| Adverse Event, n (%) | TREMFYA (n=534) | Secukinumab (n=511) |
|---|---|---|
| Arthralgia | 30 (6.0) | 25 (5.0) |
NAVIGATE
Langley et al (2018)7
- The incidence of arthralgia in patients treated with TREMFYA from the NAVIGATE study through week 60 is included in the following Table: Incidence of Arthralgia through Week 60
from the NAVIGATE Trial.
| Adverse Event, n (%) | TREMFYA (n=135) | Ustekinumab (n=133) |
|---|---|---|
| Arthralgia | 4 (3.0) | 0 |
RETROSPECTIVE Studies
Del Alcázar et al (2022)9 reported results from a 24-week, retrospective, multicenter study of TREMFYA in adult patients with moderate to severe plaque PsO.
- A total of 343 patients were enrolled in the study and 249 patients were followed for 24 weeks.
- Adverse events (AEs) were reported in 34 (9.9%) patients. Joint pain was reported as an AE in 6 patients, and 2 patients discontinued treatment due to joint pain.
Megna et al (2022)10 reported results from a 52-week, real-life, retrospective, single-center study of TREMFYA in adult patients with moderate to severe plaque PsO who previously failed ≥1 anti-interleukin-17.
- A total of 53 patients met the inclusion criteria for the cohort study and 44 patients completed the study through week 52.
- AEs were reported in 13 (29.5%) patients, of whom 1 (2.3%) reported arthralgia.
Literature Search
A literature search of MEDLINE®
References
| 1 | Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. |
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