scholarly journals Update on the Safety Profile of Tofacitinib in Rheumatoid Arthritis from Clinical Trials to Real-World Studies: A Narrative Review

2020 ◽  
Author(s):  
Jose María Álvaro-Gracia ◽  
Jose Francisco García-Llorente ◽  
Mónica Valderrama ◽  
Susana Gomez ◽  
Maria Montoro
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Real World ◽  
Safety Profile ◽  
Narrative Review

CT-P13 subcutaneous infliximab in gastroenterology and rheumatology

Immunotherapy ◽  
2021 ◽  
Author(s):  
Mai Ahmed ◽  
Giulia Bankov ◽  
Dan Casey ◽  
Martin Edward Perry
Keyword(s):  
Rheumatoid Arthritis ◽  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Real World ◽  
Intravenous Therapy ◽  
Self Administration ◽  
Efficacy Data ◽  
Inflammatory Conditions ◽  
Therapy Choice ◽  
Cost Implications

The drug infliximab has been a key milestone in the treatment of inflammatory conditions such as Crohn's disease, ulcerative colitis, rheumatoid arthritis and the seronegative spondyloarthritides. Biosimilar drugs followed the originator, further improving access and diversity of therapy choice. Subcutaneous infliximab (CT-P13) holds potential for greater patient flexibility by self administration, reducing travel and hospital attendance for infusion, particularly relevant at a time of pandemic. We highlight the pharmacodynamic and pharmacokinetic basis of the subcutaneous device, clinical trials in rheumatology and gastroenterology and consider the safety and cost implications. Real-world switching data is required to confirm the efficacy data from clinical trials given the reduction in dosing flexibility compared with intravenous therapy.

scholarly journals Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012700
Author(s):  
Stephen L Hauser ◽  
Ludwig Kappos ◽  
Xavier Montalban ◽  
Licinio Craveiro ◽  
Cathy Chognot ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Real World ◽  
Safety Profile ◽  
Progressive Multiple Sclerosis ◽  
Continuous Treatment ◽  
Primary Progressive Multiple Sclerosis ◽  
Class Iii ◽  
Primary Progressive ◽  
Controlled Treatment

ObjectiveTo report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) enrolled in clinical trials or treated in real-world postmarketing settings.MethodsSafety analyses are based on integrated clinical and laboratory data for all patients who received OCR in 11 clinical trials, including the controlled treatment and open-label extension (OLE) periods of the phase 2 and 3 trials, plus the phase 3b trials VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, CONSONANCE, and LIBERTO. For selected adverse events (AEs), additional postmarketing data were used. Incidence rates of serious infections (SIs) and malignancies were contextualized using multiple epidemiologic sources.ResultsAt data cut-off (January 2020), 5,680 patients with multiple sclerosis (MS) received OCR (18,218 patient years [PY] of exposure) in clinical trials. Rates per 100 PY (95% CI) of AEs (248; 246–251), serious AEs (7.3; 7.0–7.7), infusion-related reactions (25.9; 25.1–26.6), and infections (76.2; 74.9–77.4) were similar to those within the controlled treatment period of the phase 3 trials. Rates of the most common serious AEs, including SIs (2.01; 1.81–2.23) and malignancies (0.46; 0.37–0.57), were consistent with the ranges reported in epidemiologic data.ConclusionContinuous administration of OCR for up to 7 years in clinical trials, as well as its broader use for more than 3 years in the real-world setting, are associated with a favorable and manageable safety profile, without emerging safety concerns in a heterogeneous MS population.Classification of evidenceThis analysis provides Class III evidence that long-term, continuous treatment with OCR has a consistent and favorable safety profile in patients with RMS and PPMS. This study is rated Class III because of the use of OLE data and historical controls.

scholarly journals Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis

2016 ◽  
Vol 76 (2) ◽  
pp. 414-417 ◽  
Author(s):  
Gerd R Burmester ◽  
Robert Landewé ◽  
Mark C Genovese ◽  
Alan W Friedman ◽  
Nathan D Pfeifer ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Hepatitis B ◽  
Influenza Vaccination ◽  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Safety Profile ◽  
Spontaneous Abortions ◽  
Hepatitis B Reactivation ◽  
Link Type

BackgroundAdalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10 years and has a well-established safety profile across multiple indications.ObjectiveTo update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA.MethodsThis analysis includes 15 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry.ResultsSerious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B reactivation. No significant laboratory abnormalities were reported with adalimumab-plus-methotrexate compared with placebo-plus-methotrexate. Influenza-related AEs occurred in 5% of vaccinated patients compared with 14% of patients not vaccinated during the study. Relative risk of major birth defects and spontaneous abortions in adalimumab-exposed women were similar between that of unexposed women with RA and healthy women.ConclusionsThis analysis confirms and expands the known safety profile of adalimumab and reports no additional safety risk of laboratory abnormalities, hepatitis B reactivation and pregnancy outcomes, including spontaneous abortions and birth defects. The benefits of influenza vaccination are reinforced.Trial registration numbersNCT00195663, NCT00195702, NCT00448383, NCT00049751, NCT00234845, NCT00650390, NCT00235859, NCT00647920, NCT00649545, NCT00647491, NCT00649922, NCT00538902, NCT00420927, NCT00870467, NCT00650156, NCT00647270, NCT01185288, NCT01185301.

scholarly journals Rheumatoid Arthritis Real-world Management Over 20 Years

2021 ◽  
pp. jrheum.201189
Author(s):  
Elena Nikiphorou ◽  
Fowzia Ibrahim ◽  
David L. Scott
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Cohort Studies ◽  
Prospective Study ◽  
Real World ◽  
Observational Studies ◽  
Patient Management ◽  
Routine Practice ◽  
Prospective Cohort Studies ◽  
A Prospective Study

Clinical trials show which treatments improve rheumatoid arthritis (RA), whereas observational studies show how patients are managed in routine practice. Prospective cohort studies give the most detailed information about what happens to patients, but being a part of a prospective study influences patient management because patients are no longer routine cases.

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