FRI0122 REAL-WORLD SAFETY DATA FROM PATIENTS WITH RHEUMATIC DISEASES TREATED WITH CT-P13, AN INFLIXIMAB BIOSIMILAR: AN INTERIM ANALYSIS FROM AN OBSERVATIONAL STUDY

Background Natalizumab is a highly efficacious treatment for relapsing-remitting multiple sclerosis (RRMS). Objective To assess the real-world long-term safety of natalizumab in RRMS. Methods This multicenter, 5-year prospective observational study, included adults with RRMS newly initiated on natalizumab as per the approved product label in the routine care in Greece. Safety was evaluated by collecting serious adverse events (SAEs) following study enrollment. Results Between 19-Apr-2012 and 18-Dec-2014, 304 eligible patients (median age at natalizumab initiation: 38.0 years; median disease duration: 6.2 years) were enrolled by 20 hospital-based neurologists. Over a median treatment duration period of 58.7 months, 50.7% of the patients discontinued natalizumab, mainly due to anti-JCV antibody detection (59.1%). The adverse event treatment discontinuation rate was 5.2%. The SAE incidence rate during the safety data collection period (median: 48.7 months) was 4.6%. The most common SAEs were infections (1.0%), including 2 cases (0.7%) of progressive multifocal leukoencephalopathy (PML), and no other opportunistic infections. PML diagnoses occurred 6.2-6.7 years after natalizumab initiation, and approximately 2 years after first detection of anti-JCV antibody for both patients. The incidence rate of malignancies was 0.7%. Conclusion In real-world settings in Greece, natalizumab displayed an acceptable safety profile, with no new safety signals emerging.

Download Full-text

Prospective observational study on Pazopanib in patients treated for advanced or metastatic renal cell carcinoma in countries in Asia Pacific, North Africa, and Middle East regions: PARACHUTE study

BMC Cancer ◽

10.1186/s12885-021-08738-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Erman Mustafa ◽

Biswas Bivas ◽

Danchaivijitr Pongwut ◽

Chen Lingwu ◽

Yoke Fui Wong ◽

...

Keyword(s):

Middle East ◽

Observational Study ◽

North Africa ◽

Real World ◽

Safety Data ◽

Dose Intensity ◽

Clinical Effectiveness ◽

Asia Pacific ◽

Observational Period ◽

Middle East Countries

Abstract Background Clinical effectiveness and safety data of pazopanib in patients with advanced or mRCC in real-world setting from Asia Pacific, North Africa, and Middle East countries are lacking. Methods PARACHUTE is a phase IV, prospective, non-interventional, observational study. Primary endpoint was the proportion of patients remaining progression free at 12 months. Secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI). Results Overall, 190 patients with a median age of 61 years (range: 22.0–96.0) were included. Most patients were Asian (70%), clear-cell type RCC was the most common (81%), with a favourable (9%), intermediate (47%), poor (10%), and unknown (34%) MSKCC risk score. At the end of the observational period, 78 patients completed the observational period and 112 discontinued the study; 60% of patients had the starting dose at 800 mg. Median RDI was 82%, with 52% of patients receiving < 85%. Of the 145 evaluable patients, 56 (39%) remained progression free at 12 months, and the median PFS was 10 months (95% CI: 8.48–11.83). 19% of patients (21/109) were long-term responders (on pazopanib for ≥18 months). The best response per RECIST 1.1 was CR/PR in 24%, stable disease in 44%, and PD in 31%. Most frequent (> 10%) TEAEs related to pazopanib included diarrhoea (30%), palmar-plantar erythrodysesthesia syndrome (15%), and hypertension (14%). Conclusions Results of the PARACHUTE study support the use of pazopanib in patients with advanced or mRCC who are naive to VEGF-TKI therapy. The safety profile is consistent with that previously reported by pivotal and real-world evidence studies.

Download Full-text