Tremfya Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably causally associated with the use of Guselkumab (Tremfya) based on the comprehensive assessment of the available adverse event information. A causal relationship with guselkumab cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical studies experience in adult patients with psoriasis and psoriatic arthritis: The safety profile of Guselkumab (Tremfya) is based on data from the Phase 2 (PSO2001, PSA2001) and Phase 3 (VOYAGE 1, VOYAGE 2, NAVIGATE, ORION, ECLIPSE, DISCOVER 1, DISCOVER 2) studies in 3940 subjects, including 2711 with plaque psoriasis and 1229 subjects with psoriatic arthritis. The duration of exposure to Guselkumab (Tremfya) is presented in Table 18. (See Table 18.)

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Adverse reactions: Adverse reactions to Guselkumab (Tremfya) are presented in Table 19. The frequency of adverse reactions was based on those that occurred during the placebo-controlled periods of the studies in psoriasis (VOYAGE 1 and VOYAGE 2) and psoriatic arthritis (DISCOVER 1 and DISCOVER 2). Overall, the safety profile was generally similar across doses and indications. Within each frequency grouping, the adverse reactions are presented within the designated system organ classes in order of decreasing frequency, using the following convention: Very common (≥1/10); Common (frequent) (≥1/100, <1/10); Uncommon (infrequent) (≥1/1000, <1/100); Rare (≥1/10000, <1/1000). (See Table 19.)

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Transaminases increased: In two Phase 3 psoriatic arthritis clinical studies, through the placebo-controlled period, adverse events of increased transaminases (includes alanine aminotransferase (ALT) Increased, aspartate aminotransferase (AST) Increased, Hepatic Enzyme Increased, Transaminases Increased, Liver Function Test Abnormal, Hypertransaminasemia) were reported more frequently in the Guselkumab (Tremfya)-treated groups (8.6% in the 100 mg q4w group and 8.3% in the 100 mg q8w group) than in the placebo group (4.6%). Through 1-year, adverse events of increased transaminases (as previously mentioned) were reported in 12.9% of patients in the q4w group and 11.7% of patients in the q8w group.
Based on laboratory assessments, an increased incidence of liver enzyme elevations was observed in patients treated with Guselkumab (Tremfya) q4w compared to patients treated with Guselkumab (Tremfya) q8w or placebo. Most transaminase (ALT and AST) increases were ≤ 3 x upper limit of normal (ULN). Transaminase increases from > 3 to ≤ 5 x ULN and > 5 x ULN were low in frequency (Table 3). A similar pattern was observed through the end of the 2-year Phase 3 psoriatic arthritis clinical study. In most cases, the increase in transaminases was transient and did not lead to discontinuation of treatment. (See Table 20.)

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Gastroenteritis: In VOYAGE 1 and VOYAGE 2 through the placebo-controlled period, gastroenteritis occurred more frequently in the TRADENAME treated group (1.1%) than in the placebo group (0.7%). Adverse events of gastroenteritis were non-serious and did not lead to discontinuation of Guselkumab (Tremfya) through Week 48.
Injection site reactions: In VOYAGE 1 and VOYAGE 2 through Week 48, 0.7% of Guselkumab (Tremfya) injections and 0.3% of placebo injections were associated with injection site reactions. Adverse events of injection site erythema and injection site pain were all mild to moderate in severity, none were serious, and none led to discontinuation of Guselkumab (Tremfya).
Clinical studies experience in adult patients with palmoplantar pustulosis: The safety of Guselkumab (Tremfya) was studied in one Phase 3 study of 157 Japanese subjects with palmoplantar pustulosis (PPP) treated with Guselkumab (Tremfya) for up to 52 weeks. In general, the safety profile in this study was similar to that seen in previous studies in adults with plaque psoriasis and/or psoriatic arthritis (see Clinical studies experience in adult patients with psoriasis and psoriatic arthritis as previously mentioned).
Postmarketing data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience (Table 19). Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In the table, the frequencies are provided according to the following convention: Very common ≥ 1/10; Common ≥ 1/100 and <1/10; Uncommon ≥ 1/1000 and <1/100 Rare ≥ 1/10000 and <1/1000; Very rare <1/10000, including isolated reports; Not known Cannot be estimated from the available data. (See Table 21.)

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