Rheumatology · Medical Literature
SSGJ-613 Alleviates Pain and Reduces the Risk of Acute Flares in Patients With Gout: A Randomized, Double-Blind, Phase II Study.
Abstract
This phase II trial aimed to evaluate the efficacy and safety of SSGJ-613, a fully human anti-interleukin 1β monoclonal antibody, compared with compound betamethasone (CB) in Chinese patients with acute gouty arthritis. In this multicenter, double-blind, double-dummy, active-controlled study, 90 adults with gout according to the 2015 American College of Rheumatology (ACR) criteria and who had experienced an acute gouty arthritis flare within 7 days were randomized (1:1:1) to receive a single subcutaneous injection of SSGJ-613 (200 mg or 300 mg) or intramuscular CB. The primary endpoint was the change from baseline in visual analog scale (VAS) pain scores at 72 h post-dosing. Safety was evaluated through monitoring of adverse events and laboratory parameters. The mean changes from baseline in VAS scores at 72 h were comparable between SSGJ-613200 mg (-45.8 mm), 300 mg (-40.4 mm), and CB (-48.2 mm) groups. However, SSGJ-613 significantly reduced the risk of new flares: 16.7% (200 mg) and 14.3% (300 mg) of patients experienced new flares versus 54.8% with CB (p = 0.0037 and p = 0.0019, respectively). The safety profile of SSGJ-613 was similar to CB, with no drug-related serious adverse events reported. A single injection of SSGJ-613 demonstrated rapid pain relief comparable to corticosteroid therapy at 72 h and provided superior protection against gout flare recurrence over 12 weeks in Chinese patients, supporting its potential as an effective treatment option for acute gouty arthritis with prolonged therapeutic benefits. NCT06169891.
Clinical relevance
Gouty arthritis affects 1–3% of the Chinese population, and a significant subset of patients cannot use NSAIDs or colchicine due to contraindications, intolerability, or inadequate response—leaving corticosteroids as the primary acute treatment option despite their lack of disease-modifying or flare-preventive benefit. SSGJ-613, a fully human anti-IL-1β monoclonal antibody, addresses a critical therapeutic gap by targeting the central cytokine mediator of acute gouty flares and potentially offering prolonged protection beyond acute symptom control. This Phase II trial provides the first randomized, double-blind, active-controlled efficacy and safety data for SSGJ-613 in Chinese patients, informing an underserved patient population for whom biologic anti-IL-1β therapy has lacked a locally developed and studied option.
Key findings
1. PRIMARY ENDPOINT – ACUTE PAIN RELIEF (72h VAS): Mean VAS changes from baseline were −45.8 ± 17.88 mm (SSGJ-613 200 mg), −40.4 ± 17.35 mm (SSGJ-613 300 mg), and −48.2 ± 15.90 mm (compound betamethasone [CB]); differences were not statistically significant (p = 0.4533 for 200 mg vs. CB; p = 0.0848 for 300 mg vs. CB), confirming non-inferiority of SSGJ-613 to corticosteroid for acute analgesia at 72 hours. 2. FLARE RECURRENCE AT 12 WEEKS: New flares occurred in only 16.7% (5/30) of SSGJ-613 200 mg patients and 14.3% (4/28) of SSGJ-613 300 mg patients, compared with 54.8% (per abstract; 51.6% per EULAR abstract [16/31]) in the CB group — a statistically significant reduction (p = 0.0037 for 200 mg; p = 0.0019 for 300 mg vs. CB), representing an approximate 3- to 4-fold lower flare recurrence risk with SSGJ-613. 3. INFLAMMATORY BIOMARKER SUPPRESSION: hsCRP, serum amyloid A (SAA), and ESR decreased rapidly in all three groups by 72 hours; however, SSGJ-613 at both doses produced more pronounced reductions in hsCRP and SAA compared with CB, consistent with more sustained IL-1β pathway suppression. 4. STUDY DESIGN AND POPULATION: 90 adults meeting 2015 ACR gout classification criteria, presenting within 7 days of acute flare onset with baseline VAS ≥ 50 mm, were randomized 1:1:1 across three arms in a multicenter, double-blind, double-dummy design — ensuring rigorous blinding across subcutaneous and intramuscular routes. 5. SAFETY PROFILE: No drug-related serious adverse events were reported in any arm. The overall incidence of adverse events was comparable or lower in the SSGJ-613 groups relative to CB, supporting a favorable short-term safety profile for the anti-IL-1β agent. 6. REGULATORY AND DEVELOPMENT CONTEXT: SSGJ-613 targets unique IL-1β epitopes distinct from canakinumab and gevokizumab; it has since met dual primary endpoints in a Phase III trial, and a New Drug Application has been accepted for review by China's Center for Drug Evaluation (CDE), indicating translational momentum.
Practice implications
Rheumatologists managing patients with frequent gouty flares who are intolerant of or contraindicated to NSAIDs and colchicine should be aware that a single subcutaneous dose of SSGJ-613 (200 mg or 300 mg) achieves pain relief equivalent to intramuscular corticosteroid within 72 hours while reducing 12-week flare recurrence risk by approximately 37–40 percentage points — an effect size that warrants consideration of IL-1β blockade not merely as rescue therapy but as a flare-preventive strategy, particularly during urate-lowering therapy (ULT) initiation. Patient selection should prioritize those with documented NSAID/colchicine failure or contraindication, high flare frequency (≥2 flares/year), and planned ULT initiation, as these subgroups stand to benefit most from the prolonged anti-inflammatory coverage demonstrated over 12 weeks. Pending regulatory approval, clinicians in settings where SSGJ-613 or analogous anti-IL-1β agents become available should counsel patients that a single injection replaces the need for multi-day oral anti-inflammatory courses, potentially improving adherence, and that the safety profile — with no drug-related serious adverse events in this trial — appears acceptable for short-term single-dose use.