Obinutuzumab Induces Histologic Remission and Deep Kidney Parenchymal B-cell Depletion in Patients with Lupus Nephritis: Exploratory Analyses from a Phase III Trial

Presenter: Richard Furie

In the REGENCY trial, paired kidney biopsies from 64 patients with proliferative lupus nephritis (32 OBI+ST, 32 PBO+ST) and B-cell analyses from 29 patients (14 OBI+ST, 15 PBO+ST) were evaluated at Week 76. A significantly higher proportion of patients receiving OBI+ST achieved complete or near-complete histologic remission, defined as an activity index of 0 or ≤1, compared with PBO+ST. Among patients without complete renal response, 52.6% (10/19) in the OBI+ST group achieved AI=0 versus 8.3% (2/24) with placebo. Kidney tissue B-cell depletion was markedly greater with obinutuzumab, with adjusted mean B-cell count changes of −28.5 versus −11.9, yielding a significant difference of −16.6 (P<0.0001). These findings support deep tissue B-cell depletion as a potential mechanism for improved long-term renal outcomes.

Infection and Venous Thromboembolic Safety of Upadacitinib, Tofacitinib, and Tumor Necrosis Factor Inhibitors in Rheumatoid and Psoriatic Arthritis

Presenter: Gunjan Rana 

In a real-world TriNetX analysis of 39,252 patients with rheumatoid arthritis or psoriatic arthritis initiating TNFi (76.4%), tofacitinib (13.3%), or upadacitinib (10.2%), No statistically significant difference in serious infections was observed between either JAK inhibitor and TNFi. The hazard ratio (HR) for serious infections was 1.11 for both upadacitinib (95% CI 0.84–1.46) and tofacitinib (95% CI 0.88–1.40). The risk of DVT/PE was not increased across all pairwise comparisons. Herpes zoster risk was significantly higher with upadacitinib (HR 1.89) and tofacitinib (HR 1.62) versus TNFi. Osteomyelitis was increased with tofacitinib (HR 2.60). Mortality was not significantly different (tofacitinib vs TNFi: HR 1.21).

Long-Term Hematologic, Infectious, Critical Illness, and Survival Outcomes with JAK Inhibitors Versus TNF Inhibitors in Autoimmune Rheumatologic Diseases: A Multi-Year Propensity-Matched Real-World Study

Presenter: Riya Shah

In a TriNetX real-world study, propensity score-matched cohorts of approximately 15,000 patients per treatment group were evaluated over 1-, 2-, 3-, and 5-year follow-up periods. At 5 years, TNFi treatment was associated with lower recorded rates of selected outcomes than JAKi treatment, with lower all-cause mortality (4.5% vs 5.9%; HR 0.64), acute respiratory failure (2.9% vs 4.6%; HR 0.55), sepsis (3.0% vs 3.9%; HR 0.66), ICU admission (3.2% vs 3.9%; HR 0.69), leukopenia (7.6% vs 8.6%; HR 0.76), and severe anemia (2.1% vs 2.8%; HR 0.64). Hyperferritinemia and transfusion risks attenuated over time but remained significant in time-to-event analyses. Findings suggest a progressive long-term safety burden with JAKi, including hematologic toxicity, severe infections, and critical illness risk. As this was a retrospective database analysis, residual confounding and treatment-channeling cannot be excluded.

Long-Term Efficacy of Upadacitinib in Patients with Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): Insights from SELECT-YOUTH Trial Across Multiple Therapy Lines

Presenter: Hermine Brunner 

In the phase 1 SELECT-YOUTH trial, 122 patients aged 2 to <18 years with polyarticular-course juvenile idiopathic arthritis received weight-based upadacitinib (maximum 15 mg/day). Overall, 89% (109/122) completed 48 weeks of treatment. Before upadacitinib, 54.1% (66/122) had received csDMARDs, 22.1% (27/122) bDMARDs, and 11.5% (14/122) TNF inhibitors. JIA-ACR50/70/90/100 response rates improved from weeks 12–48 and were comparable regardless of prior csDMARD, bDMARD, or TNFi exposure. Rates of low disease activity (JADAS-27 ≤3.8) and inactive disease (JADAS-27 ≤1) at week 48 were also similar across treatment-history groups. Mean pain reduction was greater in csDMARD-naïve vs experienced patients (−37.3 vs −25.0), while C-HAQ improvements were similar. Upadacitinib showed sustained efficacy across multiple prior therapy lines. 

Children with Obesity and JIA may Require Higher Adalimumab Dosages: Results from a Prospective, Multicenter Pharmacokinetic Study

Presenter: Stephen Balevic 

In a prospective multicenter study of 36 children with JIA receiving adalimumab, 29 patients were included in the pharmacokinetic analysis, providing 41 samples. The cohort included 6 obese (20.7%), 4 overweight (13.8%), and 18 females (62.2%), with a mean age of 11.5 years and mean BMI percentile of 55.6%. Children who were overweight or obese had approximately 30% higher adalimumab clearance (41.3 vs 29.7 mL/hr), resulting in lower simulated drug levels. Clinical improvement was significantly poorer, with mean cJADAS10 change of −0.4 (n=11) versus −9.0 (n=12) in non-overweight children (p=0.003). Declining trough concentrations were most evident in children >30 kg, .raising the possibility of lower adalimumab exposure in children with overweight or obesity. These exploratory findings require validation and do not support changes to currently approved dosing.

Real-World Assessment of Anakinra Use in United States Inpatient Settings

Presenter: Christopher McPherson

In a retrospective analysis of the Premier Healthcare Database, 3,060 unique patients received anakinra across 3,375 inpatient hospitalizations at 166 hospitals between 2019–2024. Hospitalizations increased from 164 (2019) to 1,935 (2020–2021) and remained elevated at 1,276 (2022–2024). Patients had a mean age of 46 years, 59% were male, and 45% White. Pre-COVID, common diagnoses included infectious/parasitic diseases (50%), HLH (34%), and neoplasms (32%). During COVID, ARDS (64%), COVID-19 (61%), and viral pneumonia (48%) predominated. Post-COVID, infectious/parasitic diseases (50%), neoplasms (34%), and HLH (27%) remained common, while COVID-19 occurred in only 6% of admissions. Mean hospital stay was 22 days, 44–48% required ICU care, and 8–20% experienced 30-day readmission, highlighting broad inpatient use beyond approved indications.

Real-World Comparative Effectiveness of Upadacitinib Versus Tumor Necrosis Factor Inhibitors or Interleukin-17 Inhibitors on Skin Symptoms in Patients with Psoriatic Arthritis

Presenter: Philip Mease

In the real-world Adelphi Real World Spondylarthritis Disease Specific Programme, 991 bio-naïve patients with PsA initiated UPA (n=99), TNFi (n=645), or IL-17i (n=247), while 381 TNFi-experienced patients initiated UPA (n=108), TNFi (n=111), or IL-17i (n=162). Approximately 74–85% had mild-to-moderate skin disease at baseline. In bio-naïve patients, UPA showed comparable rates of no psoriatic skin lesions (71.7% vs 65.6% TNFi vs 65.3% IL-17i), no genital psoriasis (98.0% vs 97.2% vs 98.8%), no scalp psoriasis (89.9% vs 91.6% vs 86.9%), no nail deformation (93.9% vs 90.4% vs 89.2%), and mild/no skin involvement (88.9% vs 87.7% vs 88.8%; all P>0.05). Similar results were observed in TNFi-experienced patients, with no significant differences between UPA, TNFi, and IL-17i across all skin outcomes.

Comparative Risk of Herpes Zoster and Pneumonia Among Tofacitinib, Baricitinib, and Upadacitinib in Rheumatoid Arthritis: A Propensity Score-Matched Analysis of the TriNetX Research Network

Presenter: Asmaa Beltagy

In a real-world propensity score-matched study of RA patients receiving tofacitinib (TOFA, n=12,561), baricitinib (BARI, n=813), or upadacitinib (UPA, n=5,463), cohorts were well balanced (mean age ~55–61 years, 74–80% female). Herpes zoster risk was low and comparable across agents at 1 year: TOFA vs UPA HR 0.83 (95% CI 0.61–1.14), UPA vs BARI HR 1.30 (0.66–2.59), and BARI vs TOFA HR 0.69 (0.37–1.29), with all p>0.20. Pneumonia risk was higher with BARI versus TOFA at 1 year (5.6% vs 2.7%; HR 2.23; p=0.006) and 2 years (8.5% vs 4.9%; HR 1.91; p=0.004), and versus UPA at 2 years (8.4% vs 3.9%; HR 1.79; p=0.018). UPA and TOFA showed similar pneumonia risk at 1 year (HR 0.88) and 2 years (HR 1.02). These findings suggest comparable HZ risk but a higher pneumonia risk with baricitinib.

Site-Specific Mucosal Candidiasis Associated with Bimekizumab, Secukinumab, and Guselkumab: A Pharmacosurveillance Analysis of the FDA Adverse Event Reporting System (FAERS)

Presenter: Maria Shamsi

In a FAERS pharmacovigilance analysis through June 2026, 3,934 bimekizumab, 153,055 secukinumab, and 32,523 guselkumab adverse event reports were evaluated. Oral candidiasis was reported in 210 cases (5.34%) with bimekizumab versus 532 (0.35%) with secukinumab and 14 (0.04%) with guselkumab. Oesophageal candidiasis occurred in 63 (1.60%), 133 (0.09%), and 2 (0.006%) cases, respectively. Vulvovaginal candidiasis was reported in 10 (0.25%), 127 (0.08%), and 4 (0.01%) cases, respectively. Pairwise disproportionality analyses (RORs/PRRs) consistently showed higher reporting frequencies of all site-specific mucosal candidiasis with bimekizumab, with the strongest signals for oral and oesophageal candidiasis, suggesting a potential safety signal associated with dual IL-17A/F inhibition.

Secukinumab Delays Time to Relapse in Patients with Polymyalgia Rheumatica After Treatment Discontinuation: Results from the Treatment-Free Follow-up Period in REPLENISH

Presenter: Robert Spiera

In the phase 3 REPLENISH trial, relapse during the 24-week treatment-free follow-up period occurred in 44.2% (23/52) of patients receiving secukinumab 300 mg, 43.1% (22/51) receiving secukinumab 150 mg, and 61.5% (16/26) receiving placebo among those in sustained remission at Week 52. Relapse-free survival was longer with secukinumab, with median time to first relapse of 171.0 days (95% CI 147.0, NC) for SEC-300 and not calculable (95% CI 128.0, NC) for SEC-150 versus 112.5 days (95% CI 84.0, NC) for placebo. Patients who relapsed had longer baseline disease duration (1.5 vs 0.8 years, 1.9 vs 1.2 years, and 2.2 vs 1.4 years for SEC-300, SEC-150, and placebo, respectively) and greater prior relapse burden. Median time to relapse was numerically longer with secukinumab than with placebo in the selected subgroup of patients who achieved sustained remission at Week 52.

ACR Convergence 2026, November 6–11, Orlando, Florida.