adalimumab (Anjiarun / SCT630 / SCT 630)

Tofacitinib for Refractory Non-Infectious Ocular Inflammation: A Retrospective Observational Study.

Mooss Vidya S VS, Babu Kalpana K, Mundot Puliappadamb Haridas H

To evaluate the clinical indications, effectiveness, and cost implications of tofacitinib in refractory non-infectious ocular inflammation. This retrospective study included 60 patients treated with tofacitinib at a tertiary eye care centre in South India, between January 2020 and January 2026. Data collected included demographics, anatomical/etiological diagnoses, prior immunomodulation, indications, treatment regimen, adverse events of tofacitinib, and duration of follow-up. Ocular inflammatory flares before and after tofacitinib were quantified and expressed as incidence rates/1,000 person-months. Incidence-rate-ratios were estimated using Poisson regression with log person-months as an offset. A descriptive cost and exploratory cost-effectiveness analysis was performed. Mean age: 43.5 ± 13.8 years; 61.7% were female. Tofacitinib was initiated for recurrent ocular inflammation in 91.7%. Median duration of tofacitinib therapy: 11 months (range: 6-24). Number of ocular inflammatory flares decreased from 263 before tofacitinib to 34 after tofacitinib. The incidence rate declined from 275.1 to 47.5 episodes/1,000 person-months, corresponding to a significant reduction in flare incidence (p<0.001), representing approximately an 83% reduction. A greater proportion of patients achieved better visual acuity at final follow-up(p = .0001). Adverse events occurred in 13.8% of patients, commonly dyslipidaemia. A total of 229 flares were prevented, with an estimated cost-per-flare avoided of approximately ₹7,200 (76 USD). Among patients switched from mycophenolate-mofetil/adalimumab, tofacitinib therapy was associated with an average cost saving of ₹79,369/ patient and ₹9,458/ patient-month. Tofacitinib was associated with a significant reduction in ocular flares and improvement in visual outcomes in patients with refractory non-infectious ocular inflammation. These findings suggest that JAK inhibition may represent an effective and economically viable therapeutic option for selected patients with difficult-to-treat ocular inflammatory disease.

Population PK/PD Modeling and Simulation to Predict the Comparative Long-Term Efficacy of Olokizumab in Rheumatoid Arthritis Patients.

Kosinsky Yuri Y, Azarov Ivan I, Zhudenkov Kirill K, Peskov Kirill K et al.

Background/Objectives: Olokizumab (OKZ) is a humanized monoclonal antibody targeting interleukin-6 (IL-6). OKZ demonstrated efficacy in subjects with active rheumatoid arthritis (RA) in randomized controlled trials versus adalimumab (ADLM) and placebo over 24 weeks, with sustained efficacy confirmed through 106 weeks in an open-label single-arm extension study (OLE). This analysis aimed to predict 1-year efficacy of OKZ 64 mg administered every two weeks (q2w) and every four weeks (q4w) compared with ADLM and placebo through virtual clinical trial simulations based on population pharmacokinetic/pharmacodynamic (PK/PD) models. Methods: Nonlinear mixed-effects models were developed using pooled data from phase III studies. Turnover models with a maximum inhibition Imax-type relationship between OKZ concentrations and clinical scores were applied. Simulated clinical trials were performed to estimate 52-week response rates, defined as proportions of patients achieving low disease activity (DAS28-CRP ≤ 3.2) and remission (CDAI ≤ 2.8). The reliability of the simulated extrapolations was validated against published data. Results: Log-transformed C-reactive protein (CRP) baseline levels and region were identified as significant covariates, influencing the dynamics of RA activity scores. OKZ and ADLM showed comparable predicted efficacy profiles, with overlapping 95% prediction intervals, and both were superior to placebo. Model predictions showed strong agreement with published long-term data for ADLM and placebo and closely reproduced the actual 1-year response profiles from the OKZ OLE. Conclusions: The developed PK/PD models showed good agreement with observed long-term efficacy outcomes for OKZ, ADLM, and placebo in MTX-IR RA patients. Both OKZ dosing regimens sustained low disease activity and remission rates comparable with those for ADLM over 52 weeks, supporting their use as effective treatment options.

Gastrointestinal Involvement in Pediatric Behçet's Disease: A Focused Analysis from a Comprehensive Systematic Review.

Poddighe Dimitri D, Rigante Donato D, Romano Micol M, Mukusheva Zaure Z et al.

Background: Gastrointestinal (GI) involvement is a clinically relevant but still incompletely characterized manifestation of pediatric Behcet's disease (PedBD). This systematic review provides a focused analysis of GI involvement in PedBD (addressing its frequency, clinical symptomatology, anatomical/endoscopic features, and therapeutic management) as a dedicated sub-analysis of a broader systematic review. Methods: A systematic search of MEDLINE, EMBASE, CINAHL, CENTRAL, and ClinicalTrials.gov was conducted, following PRISMA 2020 guidelines. Observational studies reporting GI involvement in patients with PedBD (disease onset before 16 years of age) were included, and data on frequency, symptoms, anatomical/endoscopic findings, and treatment of GI-PedBD were extracted and synthesized. Results: Thirty studies were included. Most studies were not focused on GI manifestations in PedBD as a (primary) study aim. The frequency of GI involvement ranged widely across the selected articles with a median of approximately 15% among studies with ≥50 pediatric BD patients. Abdominal pain and diarrhea were the most consistently reported symptoms. Endoscopic data indicated frequent involvement of the ileocecal region and terminal ileum, with mucosal ulcers and erosions as the predominant findings. Therapeutic data specific to GI-PedBD were limited to two studies only. As an appendix to the systematic review in the discussion, relevant case reports were described: anti-TNF agents, particularly adalimumab, showed favorable outcomes in refractory cases. Conclusions: GI involvement in PedBD is not negligible and can be severe. Its clinical and endoscopic characterization remains incomplete due to substantial heterogeneity in reporting practices across studies. Anti-TNF agents may represent an effective therapeutic option, especially for refractory GI-PedBD. Prospective and multicenter studies with standardized GI assessment protocols are needed to better characterize this clinically relevant subgroup of PedBD patients.

Refractory Acne in SAPHO Syndrome Rapid Resolution Following Adalimumab Therapy.

Xu Cheng C, Ouyang Mingli M, Han Yongmei Y