Study Phases:

Screening Period: 4 weeks

Core Treatment Period: 12 weeks

Extension Period: 12 weeks

Follow-Up Period: 8 weeks

Intervention and Randomization: Patients were randomized 1:1:1 to receive:

120 mg vunakizumab

240 mg vunakizumab

Placebo

Treatments were administered subcutaneously at week 0, then every 2 weeks for 3 doses, followed by every 4 weeks.

At week 12, patients in the placebo group were re-randomized to receive either 120 mg or 240 mg vunakizumab for the extension period.

Patient Numbers:

Total Screened: 149

Randomized: 112 (37 to placebo, 38 to 120 mg, and 37 to 240 mg Vunakizumab)

Completion Rate: 98.2% for the core and extension treatment periods

Primary Endpoint: ACR20 responder rate at week 12

Re-randomization at Week 12: 35 placebo patients were re-assigned to Vunakizumab:

17 to 120 mg

18 to 240 mg

Patients in the original vunakizumab groups continued their respective doses through the extension period.

Efficacy Results:

Primary Endpoint (ACR20) at week 12:

240 mg: 59.5% response rate (+37.8% over placebo).

120 mg: 47.4% response rate (+25.8% over placebo).

Placebo: 21.6%.

Secondary Endpoints:

ACR 50 at week 12:

240 mg: 43.2% response rate

120 mg: 28.9 % response rate

ACR 70 at week 12:

240 mg: 24.3% response rate

120 mg: 13.2% response rate

Marked reductions in DAS28-CRP, PASI, and HAQ-DI scores at week 12, sustained through week 24.

Safety Profile

Common AEs included upper respiratory tract infections, hyperuricemia, and mild liver dysfunction.

Most AEs were mild to moderate.

Serious Adverse Events (SAEs):

Nasal hemangioma (low-dose group) and acute myocardial infarction occurred but were unrelated to the treatment.

No AEs led to treatment discontinuation.

Study Type: Global, randomized, double-blind, placebo-controlled phase 2 trial (ARGO trial).

Population: 207 Patients with active psoriatic arthritis (PsA), stratified by biologic use and concomitant methotrexate (75%).

Placebo-Controlled Phase (Weeks 0–12): 

Patients were randomized to receive:

Sonelokimab: Initial dose of 60 mg followed by every 2 weeks up to week 8, then every 4 weeks thereafter.

Higher dose Sonelokimab: 120 mg every 4 weeks.

Active comparator: Adalimumab.

Placebo.

The primary endpoint was the ACR50 response at week 12.

Dose Escalation/Continuation Phase (Weeks 12–24):

Responders: Patients showing predefined responses continued their allocated treatment.

Placebo Non-Responders: Transitioned to the highest dose of Sonelokimab.

Sonelokimab Non-Responders: Escalated to higher doses unless they were already on the maximum dose, in which case they were switched to Adalimumab.

ACR Responses:

Week 12 ACR50: Achieved in 54.1% of patients on 120 mg Sonelokimab (primary endpoint).

By week 24:

ACR20: 73.0%.

ACR70: 43.2% for 120 mg dose.

Skin Outcomes (PASI): By week 24, PASI 90 was achieved in 83.3% patients and PASI 100 was achieved by 75% patients.

Composite Outcomes:

48.1% of patients on 120 mg achieved both ACR70 and PASI100 responses by week 24.

MDA: Up to 60% of patients achieved minimal disease activity, highlighting multi-domain effectiveness.

Type: Phase 2b, 12-week, randomized, double-blind, placebo-controlled trial.

Population: Total 290 active PsA patients stratified by prior biologic use, BMI, and concomitant DMARD therapy.

Dosing Regimens & number of patients

5 mg daily Zasocitinib (n=71)

15 mg daily Zasocitinib (n=75)

30 mg daily Zasocitinib (n=72)

Placebo comparator. (n=72)

Endpoints:

Primary: ACR50 at week 12.

Secondary: MDA (minimal disease activity), DAPSA (disease activity index for PsA) remission, and PASTAS (PsA disease activity score) thresholds.

Population Distribution: Slightly higher proportion of female patients in the 15 mg and 30 mg Zasocitinib dose groups.

Body Mass Index (BMI): A significant number of patients presented with elevated BMI.

Treatment History:

50-60% of patients were on background DMARDs.

One-third had prior biologic treatment, including TNF and IL-17 inhibitors.

Approximately 25% had prior TNF inhibitor use.

Baseline Disease Metrics:

Tender Joint Count (TJC): Averaged at 18 joints in the placebo and 5 mg groups, slightly lower in the 30 mg arm.

Swollen Joint Count (SJC): Elevated across all arms.

DAPSUS Score: Mean baseline score of 38–40 (remission goal ≤4).

PASDAS Score: Elevated baseline scores of 5.6–8 (remission goal ≤1.9).

Remission and Low Disease Activity (LDA):

15 mg and 30 mg doses demonstrated statistically significant improvement in minimal disease activity (MDA) and remission thresholds compared to placebo. 28% patients in the 15 mg group and 29% patients in the 30mg group achieved the MDA response. 

28.7% and 26.4% of patients achieved ACR50 at week 12 with 15 mg and 30 mg doses respectively. 

Composite Disease Scores:

DAPSA (Disease Activity in Psoriatic Arthritis) remission (<4) and low activity (<14) thresholds were reached by a significant proportion.

PASTAS (Psoriatic Arthritis Symptoms Score) similarly demonstrated reductions, highlighting improvements across musculoskeletal and skin domains.

Rapid Onset: Improvements in disease activity were evident by week 4, with further gains through week 12.

ACR Responses:

15 mg and 30 mg doses achieved >50% ACR50 response rates at week 12.

Significant improvements across all ACR thresholds (ACR20, ACR50, ACR70) with rapid onset.

Safety Profile:

Dose-related mild acne and rashes were observed, consistent with the TYK2 inhibition class.

No significant cardiovascular events, malignancies, or serious infections reported.

Tolerability: Most patients continued therapy without significant interruptions due to side effects.

Study Design: Prospective, Observational, International study

Population Insights: Patients: 1,314 enrolled from 20 countries, primarily in Europe.

Initiated on GUS or an IL-17i as 1st – 4th line biologic therapy per standard of care

Mean age: ~52 years.

Moderate disease activity (cDAPSA ~23-25), tender joint count 9–11, and swollen joint count 3–4.

~50% with minimal skin involvement (BSA <3%).

Higher obesity rates (35–40%) and cardiovascular comorbidities (~40%).

Differences in treatment lines: Guselkumab often used in later lines, with slightly higher skin involvement in these patients.

Efficacy Outcomes:

Patient-perceived Disease Impact:

Significant reduction in PsAID-12 scores from baseline (5.1) to 6 months (3.6) in the GUS group and baseline (5.0) to 6 months (3.3) in the IL-17i group. 

Key improvements noted in pain, fatigue, and general discomfort.

No statistical differences in overall PsAID-12 score reductions between guselkumab and IL-17 inhibitors after propensity score adjustment.

Clinically Important Improvements:

53% and 48% of patients achieved Minimal Clinically Important Improvement (MCII; ≥1.4-point reduction in PsAID-12) in the GUS group and the IL-17i group respectively.

No significant differences between treatment groups.

Treatment Persistence:

High retention: 94% remained on therapy at 6 months.

Discontinuation rates and reasons were similar across both cohorts.

Domain-specific Improvements:

Highest Gains: Skin problems and general discomfort, consistent with known efficacy of these biologics.

Lower Gains: Depression showed minimal improvement, reflecting its limited responsiveness to biologics.

Pain and Fatigue: Dominated patient concerns but showed meaningful reductions across both treatment arms.

Safety Observations:

Comorbidities were prevalent, particularly obesity and cardiovascular conditions.

No adverse event trends specific to either treatment arm reported during this analysis.