Latest news with #adverseEvents
Medscape
19-05-2025
- Health
- Medscape
Zimlovisertib and Tofacitinib Combo Shows Promise in RA
Zimlovisertib plus tofacitinib showed greater efficacy than tofacitinib alone in reducing Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) in patients with rheumatoid arthritis (RA), with a significant reduction observed at week 12. METHODOLOGY: This randomized, phase 2 study, conducted across 77 centers in 10 countries, aimed to evaluate the efficacy, safety, and pharmacokinetic profiles of zimlovisertib in combination with tofacitinib or ritlecitinib compared with tofacitinib alone in 460 patients (age, 18-70 years) with moderate to severe RA. Participants were randomly assigned to five groups: 400 mg zimlovisertib modified release (MR) + 11 mg tofacitinib MR (n = 103), 400 mg zimlovisertib MR + 100 mg ritlecitinib (n = 101), 400 mg zimlovisertib MR (n = 77), 100 mg ritlecitinib (n = 77), or 11 mg tofacitinib MR (n = 102). A screening period of ≤ 28 days was followed by a 24-week treatment period and a 4-week follow-up period without treatment. The primary endpoint was the change from baseline in DAS28-CRP at week 12; the secondary endpoint included DAS28-CRP remission rates at week 24. Patients were required to discontinue methotrexate prior to randomization and were monitored for treatment-emergent adverse events (TEAEs) throughout the study. TAKEAWAY: Overall, 88.7% of patients continued treatment at week 12, and 69.8% continued treatment at week 24; the main reason for discontinuation was failure to achieve the protocol-specific requirement of at least 20% improvement in American College of Rheumatology response criteria by week 12. Zimlovisertib plus tofacitinib resulted in a greater reduction in DAS28-CRP scores at week 12 than tofacitinib alone (mean change in scores from baseline, −2.65 vs −2.30; P = .032), but the reduction achieved with zimlovisertib plus ritlecitinib vs tofacitinib was not statistically significant. = .032), but the reduction achieved with zimlovisertib plus ritlecitinib vs tofacitinib was not statistically significant. The combination of zimlovisertib and tofacitinib resulted in a higher proportion of patients achieving DAS28-CRP remission at week 24 than tofacitinib alone (40.8% vs 24.0%). TEAEs were reported in 53.5% of patients, with the highest incidence in the tofacitinib monotherapy group (58.8%) and similar rates across all treatment groups. Infections and infestations were the most common TEAEs, affecting 12.6% of patients in the zimlovisertib plus tofacitinib group. IN PRACTICE: 'While improvements in clinical efficacy were seen with the combination groups vs monotherapies, there did not appear to be any increase in incidence, type, and severity of TEAEs,' the authors wrote. SOURCE: This study was led by Spencer I. Danto, MD, PhD, Pfizer Inc., Cambridge, Massachusetts. It was published online on April 14, 2025, in Arthritis & Rheumatology . LIMITATIONS: The relatively small sample size limited the generalizability of the findings. The lack of a placebo control group could have introduced bias and affected the interpretation of the results. Additionally, the study's design included programmatic discontinuation of nonresponders, which may have influenced the observed outcomes. DISCLOSURES: This study was funded by Pfizer. About 10 of the 12 authors reported being employees and shareholders of Pfizer. One author reported receiving principal investigator's grants and grants to support educational activities for physicians and employees from Pfizer.
Medscape
14-05-2025
- Health
- Medscape
Suspend Use of Chikungunya Vaccine in Adults Aged 60+
Healthcare providers should pause in their use of the chikungunya live vaccine (Ixchiq) while investigation of serious neurologic, cardiac, and other adverse events in vaccine recipients is ongoing, according to a safety communication issued jointly by the US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC). A total of 17 serious adverse events, two of which resulted in deaths, have been reported as of May 7, 2025, according to the communication. The events occurred in adults aged 62-89 years who received the live chikungunya vaccine worldwide during postmarketing availability. Six of the events occurred in the United States. Most of the serious adverse events associated with the chikungunya vaccine in the United States and overseas that have been reported to the Vaccine Adverse Event Reporting System (VAERS) have occurred in patients with underlying medical conditions and may not be causally linked to the vaccine, according to the communication. Some of the serious adverse events reported are consistent with complications from chikungunya disease, and the FDA-approved vaccine prescribing information warns that severe or prolonged chikungunya-like adverse reactions may occur. In clinical trials comparing the vaccine with placebo, severe chikungunya-like reactions were observed in 1.6% of vaccine patients vs none of placebo patients. Postmarketing reports of adverse events included one death from encephalitis. The FDA approved the vaccine for the prevention of chikungunya virus in adults aged 18 years or older who are at increased risk for exposure, and the vaccine contains a live, though weakened, version of the virus, according to the communication. Approximately 80,000 doses of the vaccine have been distributed worldwide to date. The FDA and CDC will continue to evaluate postmarketing safety reports, and the agencies recommend that healthcare providers refrain from administering the vaccine to adults aged 60 years or older while the investigations are ongoing. Healthcare providers are advised to report any adverse events in recipients of the chikungunya vaccine to VAERS.
Medscape
12-05-2025
- Health
- Medscape
UK Study Confirms Long-Term Safety of COVID-19 Vaccine
Headache and fatigue were the most commonly reported incident adverse events of the AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine in real-world settings across the United Kingdom; anosmia (loss of smell) and ageusia (loss of taste) were the most frequently reported adverse events of special interest. METHODOLOGY: This active surveillance study assessed the safety and utilisation of the AZD1222 COVID-19 vaccine in real-world settings across the United Kingdom between March 1, 2021, and April 6, 2023. Researchers recruited 17,945 participants (median age, 50 years; 60.4% women; 79.2% White) from vaccination sites, including primary care practices and hospitals. They collected follow-up data at weeks 1, 4, and 14 and at months 6, 9, 12, and 18 after the initial vaccination through electronic data capture forms to identify recipient-reported adverse events and their incidence. TAKEAWAY: Overall, 19,824 adverse events were reported in 6591 participants, which included 399 serious adverse events in 220 participants and 287 adverse events of special interest in 184 participants. Headaches had the highest incidence rate at 421.28 cases per 1000 person-years (95% CI, 404.88-438.34), followed by fatigue at 386 cases per 1000 person-years (95% CI, 370.46-402.18). Anosmia and ageusia were the most frequently reported adverse events of special interest. An increased observed-to-expected ratio was noted for anosmia and/or ageusia (39.23; 95% CI, 29.13-49.32) and anaphylaxis (7.38; 95% CI, 2.80-11.95). During the study period, 11 deaths were reported, with COVID-19 infection being the primary cause for two deaths and thrombosis for one death. IN PRACTICE: "This study highlights the requirement for pandemic preparedness, including the ongoing focus on standardising case definitions and producing background rates for AESIs [adverse events of special interest], thereby facilitating the rapid identification of safety signals via Observed versus Expected analysis," the authors wrote. SOURCE: This study was led by Alison Evans, Drug Safety Research Unit, Southampton, England. It was published online on May 02, 2025, in BMJ Open . LIMITATIONS: The study population showed demographic imbalances, with the underrepresentation of older adults and ethnic minorities. A significant loss to follow-up occurred at each timepoint, potentially leading to underreporting of longer-term outcomes. DISCLOSURES: This study was supported by AstraZeneca UK Limited. The authors reported having no competing interests.
Reuters
07-05-2025
- Health
- Reuters
Europe reviews Valneva's chikungunya vaccine after reports of serious side-effects in older people
Valneva logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights , opens new tab Companies Valneva SE Follow May 7 (Reuters) - The European Union's health regulator said on Wednesday it has begun a review of Valneva's ( , opens new tab chikungunya vaccine after reports of serious adverse events in older adults, including two deaths globally. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Reporting by Mariam Sunny in Bengaluru; Editing by Tasim Zahid Our Standards: The Thomson Reuters Trust Principles. , opens new tab Share X Facebook Linkedin Email Link Purchase Licensing Rights
