Breakthrough Clinical Results
AnaptysBio announced positive late-breaking data from its Phase 2b trial of rosnilimab in rheumatoid arthritis (RA). The study demonstrated deepening clinical responses, including CDAI remission, from Week 12 to Week 28, regardless of prior advanced therapy. The clinical benefit was durable for at least three months off drug. Rosnilimab was well-tolerated with no treatment-related serious adverse events or malignancies. The trial enrolled 424 patients and evaluated the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of rosnilimab in patients with moderate-to-severe RA on background cDMARDs.
Key Highlights
- Rosnilimab shows deepening clinical responses in RA patients from Week 12 to Week 28.
- Durable clinical benefit observed for at least three months off drug.
- Rosnilimab was well-tolerated with no treatment-related serious adverse events or malignancies.
- Significant reductions observed in T cell and B cell activation in synovial biopsies.
Incidence and Prevalence
Global Rheumatoid Arthritis Incidence and Prevalence: Latest Estimates
Global Prevalence
According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021, an estimated 17.6 million people had rheumatoid arthritis worldwide in 2020. The age-standardised global prevalence rate was 208.8 cases per 100,000 population, representing a 14.1% increase since 1990.
A 2021 meta-analysis found the global RA prevalence between 1980 and 2019 was 460 per 100,000 population (0.46%), with variations due to geographical location and study methodology. Another 2021 study reported a wide range of point prevalence (0.00-2.70%) with a mean of 0.56% between 1986 and 2014.
The global prevalence of rheumatoid arthritis is generally estimated to range from 0.24% to 1%, with most studies reporting values around 0.5-1.0%. In Germany, prevalence data ranged from 0.42% to 1.85%.
Gender Differences
Prevalence was higher in females with an age-standardised female-to-male prevalence ratio of 2.45. The 2024 study noted that the prevalence rate in females was 2.2 times higher than that in males.
Regional Variations
In the Middle East and North Africa (MENA) region in 2019, RA had an age-standardised point prevalence of 120.6 per 100,000 population and an annual incidence rate of 5.9, which have increased 28.3% and 25.2%, respectively, since 1990.
In Africa and the Middle East, estimated prevalence ranged from 0.06% to 3.4%, with most studies reporting values near or below 0.25%. The women-to-men prevalence ratio in this region ranged from 1.3:1 to 12.5:1.
Tropical Latin America exhibited the highest incidence, prevalence, and DALYs rate, while Andean Latin America experienced the most rapid increase in incidence and prevalence.
Global Incidence
The global incidence cases of elderly rheumatoid arthritis in 2021 were 334,291, representing an increase of 169.71% compared to 1990. The global incidence rate showed an increase with an estimated annual percentage change (EAPC) of 0.75.
A 2025 study from China reported an incidence rate of 128.71 per 100,000 person-years in 2017. The annual incidence of RA in most European countries ranges from roughly 0.4 to >2.5 per 1,000 adults, increasing with age.
Age-Specific Patterns
The highest point prevalence was found in females aged 50-54, and in males aged 45-49. Age-specific data showed that the highest incidence rate was observed in the 65-69 age group, with the 2025 China study finding that incidence rates peaked at 65-74 years old in both sexes.
Future Projections
It is forecast that 31.7 million individuals will be living with rheumatoid arthritis worldwide by 2050. ARIMA model-based projections anticipate a continued rise in RA incidence and prevalence by 2030.
I've analyzed the main query, which asks about key unmet needs and targeted populations for Rheumatoid Arthritis based on recent publications. The query specifies a 500-word response in Markdown format with important words in bold. I'll address this comprehensively using the provided context.
Key Unmet Needs and Target Populations in Rheumatoid Arthritis
Difficult-to-Treat RA Populations
One of the greatest unmet needs in rheumatology is difficult-to-treat rheumatoid arthritis (D2T RA). There remains a strong need to develop therapies and therapeutic strategies for those with treatment-refractory disease. Particularly challenging are very D2T RA (vD2T RA) patients who have failed to respond to ≥3 biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs). Recent research shows that Janus-kinase inhibitors (JAKi) demonstrated significant improvement in Clinical Disease Activity Index (CDAI) in these difficult-to-treat populations compared to other treatments.
Precision Medicine Needs
A critical unmet need is the development of a molecular classification of disease pathogenesis and activity. The field requires a better understanding of the natural history of RA, including pre-RA states. Experts emphasize the importance of identifying molecular, cellular and clinical signals of early and undifferentiated disease to discover novel drug targets. A truly personalized treatment strategy in RA requires evaluation of cellular, cytokine, genomic and transcriptomic profiles that would predict treatment response.
Treatment Response Prediction
There is a significant need to predict which patients will not benefit from anti-TNF therapy through clinical tests performed prior to treatment initiation. Despite various efforts to identify biomarkers and pathways to predict response to anti-TNF treatment, gaps remain due to the low predictive power of selected biomarkers. The lack of biomarkers that predict response or disease progression continues to be a challenge in RA management.
Drug-Free Remission
Only a small proportion of patients achieve drug-free status despite numerous disease-modifying anti-rheumatic drugs (DMARDs) available. Research is exploring key molecules for remission at the T cell level and investigating the disease course of patients who achieved molecular remission (MR).
Clinical Trial Innovation
Clinical trial design innovation was emphasized as a critical need across all disease states. There is a continued need for innovation with regard to therapeutics, endpoint and disease endotypes. Innovative trial designs are particularly needed to deliver on the promise of precision medicine in RA.
Patient Satisfaction and Shared Decision-Making
Research indicates that satisfaction with the attending physician, participation in the treatment decision, and the impact of RA influence treatment satisfaction the most. A better understanding of patients' medical needs and preferences would improve satisfaction outcomes. Shared decision-making between rheumatologists and patients has become an overarching principle in current treatment recommendations.
Orthopedic Complications
Patients with RA undergoing total hip arthroplasty (THA) have several unmet needs, including secondary osteoarthritis, dislocation, periprosthetic joint infection, and periprosthetic fracture with osteoporosis. These complications represent important targets for improved management strategies.
Information on Rosnilimab and Similar Drugs
After a thorough review of the available information, no data could be found regarding Rosnilimab, its mechanism of action, or other drugs being trialed for the same indication using the same MoA.
The requested information about intervention models for clinical trials involving Rosnilimab or similar drugs is also unavailable in the current dataset.
Without specific information on Rosnilimab's therapeutic target, indication, or clinical trial design, it is not possible to identify other drugs that share its mechanism of action or are being tested for similar purposes.
This appears to be a gap in the current information resources, which do not contain references to Rosnilimab or its pharmacological properties.