Shanghai Dermatology Hospital

SSGJ-608 is a recombinant, humanized, immunoglobulin G1 monoclonal antibody that targets human interleukin-17A with high specificity and high affinity.

We aimed to evaluate the efficacy and safety of SSGJ-608 in patients with moderate-to-severe psoriasis in China.

Adult patients aged 18 years or older with moderate-to-severe plaque psoriasis were randomly assigned (2:2:1) to receive subcutaneous injections of placebo (placebo group), 80 mg of SSGJ-608 every 2 weeks after a starting dose of 160 mg at week 0 (608A group), or 160 mg of SSGJ-608 every 4 weeks (608B group). At week 12, patients in the 608A group received SSGJ-608 80 mg every 4 weeks, patients in the 608B group received SSGJ-608 160 mg every 8 weeks, and patients in the placebo group were re-allocated (1:1) to either the 608A or 608B group to receive 608 80 mg every 4 weeks (with an additional 160-mg loading dose of SSGJ-608 at week 12) or 160 mg every 8 weeks. All patients received treatment until week 48. The primary endpoints were a ≥75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI75) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.

A total of 458 patients were randomly assigned to either the 608A group (n = 184), the 608B group (n = 183), or the placebo group (n = 91). At week 12, compared with those in the placebo group, a greater proportion of patients in the 608A group and in the 608B group achieved the primary endpoints of PASI75 (95.1% vs 93.4% vs 8.8%) and sPGA of 0 or 1 (76.1% vs 67.2% vs 1.1%). At week 52, PASI75 was maintained by 93.7% in the 608A group and 93.6% in the 608B group, sPGA of 0 or 1 was maintained by 89.3% in the 608A group and 89.4% in the 608B group, PASI90 was maintained by 92.6% in the 608A group and 92.5% in the 608B group, respectively. Both treatment groups demonstrated a favorable safety profile, with no increase in risk observed with longer drug exposure.

SSGJ-608 showed rapid and robust clinical response at week 12 and through week 52, and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.

ClinicalTrials.gov Identifiers: NCT05536726.

Psoriasis treatments that provide rapid and extensive itch relief as well as lesion clearance are currently inadequate.

To evaluate the efficacy and safety of the tyrosine kinase 2/Janus kinase 1 inhibitor TLL-018 in patients with moderate-to-severe psoriasis.

This phase Ib, double-blind, placebo-controlled study (NCT05342428) randomized participants to receive TLL-018 10 mg, 20 mg, 30 mg or placebo 2 : 2 : 2 : 1 orally twice daily for 12 weeks. The study included 73 patients with moderate-to-severe psoriasis. Eligible patients were aged 18–75 years and were diagnosed with moderate-to-severe psoriasis at least 6 months prior to screening, as defined by a Psoriasis Area and Severity Index (PASI) of ≥ 12, a body surface area ≥ 10% and a Physician’s Global Assessment (PGA) of ≥ 3. The primary endpoint was safety of TLL-018. The efficacy endpoints were proportions of patients at week 12 achieving a ≥ 75% improvement from baseline in PASI (PASI 75), PGA of 0 or 1 (PGA 0/1) and Dermatology Life Quality Index of 0 or 1.

A total of 73 participants were treated. TLL-018 was well tolerated, and most treatment-emergent adverse events were mild/moderate. At week 12, 40% of patients (8 of 20) achieved PASI 75 with TLL-018 10 mg, 48% (10 of 21) with 20 mg, 62% (13 of 21) with 30 mg and 9% (1 of 11) with placebo. The proportions of patients with PGA 0/1 were 35%, 43%, 71% and 0%, respectively. Of the 21 patients in the TLL-018 30-mg group, 10 (48%) achieved a ≥ 90% improvement from baseline in PASI.

TLL-018 was well tolerated and showed promising efficacy at week 12 compared with placebo in patients with moderate-to-severe plaque psoriasis.

Malassezia species can induce the expression of interleukin-17 (IL-17), which plays an important role in the inflammatory and immune response in psoriasis (PS). The purpose of this study was to investigate the Malassezia species composition in patients with PS and healthy individuals and explore the role of Malassezia species in the pathogenesis of PS.

A total of 28 patients with PS and 10 age- and sex-matched healthy individuals participated in this study. Specimens collected from the lesional and non-lesional skin of patients with PS and the skin of healthy individuals were analyzed by using nested PCR.

The relative abundance of Malassezia species was 84.96% in healthy subjects, more than twice that in patients with PS (P<0.01). M. restricta (43.09%) and M. globosa (41.38%) were the main Malassezia species in patients with PS followed by M. furfur (4.84%) and M. sympodialis (2.49%). M. sympodialis accounted for 18. 81% of the Malassezia species in healthy subjects, which was nearly eight times higher than in patients with PS (P<0.01). Further, M. furfur was detected both on lesional and non-lesional psoriatic skin, but it was not found on the skin of healthy individuals.

The Malassezia species composition in patients with PS differed from that of healthy individuals. M. restricta and M. globosa were the main Malassezia species in patients with PS.