RA patients treated with baricitinib reported greater improvements in pain compared with adalimumab5 Nov 2017
Post-hoc analysis shows pain improvement was consistent regardless of a patient's baseline pain severity.
Eli Lilly and Incyte Corporation have announced that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira (adalimumab) or placebo. A new post-hoc analysis of the Phase III RA-BEAM study disclosing outcomes of patient-reported levels of pain control was presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, California.
"While there are many treatments available for RA patients, these data suggest that baricitinib, if approved, may be an important advancement for patients suffering from RA-related pain," said James McGill, distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. "We are pleased to share these data suggesting that baricitinib could provide a potential new option for people living with RA. We remain committed to making life better for people with rheumatoid arthritis and improving patient care."
RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once daily, baricitinib 4 mg once daily or adalimumab 40 mg biweekly. All patients received background methotrexate. This post-hoc analysis reviewed outcomes of patient-reported levels of pain control during the first 24 weeks of the trial as measured by a 0-100 mm visual analog scale (VAS) during each study visit. Analyses were not adjusted for multiplicity, were exploratory in nature and further research should be conducted to confirm these results. Analysis of reduction in pain included an assessment of the time required to achieve ≥30%, ≥50% and ≥70% pain improvement, including the following results:
For patients whose baseline pain levels were higher than the median, treatment with baricitinib also led to faster pain improvements than adalimumab or placebo.
"Many RA patients continue to struggle with chronic pain," said Peter Taylor, presenting author and Professor at the University of Oxford. "These post-hoc analyses suggest that these RA patients may derive meaningful and consistent improvements in pain, particularly those patients with the highest pain at baseline."
The observed safety profile in RA-BEAM was consistent with previous trials evaluating baricitinib. The percentage of patients stopping therapy due to adverse events through Week 24 were 3% in placebo, 5% in baricitinib and 2% in the adalimumab group. Serious adverse event rates through 24 weeks were similar with placebo and baricitinib (5% each) and lower with adalimumab (2%). No additional safety signals were observed during the post-hoc analysis.
Lilly plans to resubmit the New Drug Application (NDA) with the FDA for baricitinib as a treatment for adult patients with RA before the end of January 2018. Baricitinib is approved for the treatment of adult patients with RA in several geographies, including the European Union and Japan.
Plasticell wins military contract to develop regenerative medicines for the battlefield
4 Sep 2018
Company to use its combinatorial stem cell screening platform to develop technologies for the conversion of pluripotent stem cells into platelets.Read more
New biopharmaceutical testing laboratory to open in Geneva
28 Aug 2018
SGS's expansion will enable the service provider to offer a full ICH Q6B physico-chemical characterization of biological products.Read more
Exosome isolation manufacturing and characterization
13 Aug 2018
New service to reliably and reproducibly isolate exosomes from almost any biofluid.Read more
Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines
8 Aug 2018
Company moves away from manual processing in favour of automated, scalable platforms.Read more
A new era for migraine patients
6 Aug 2018
EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.Read more
WuXi STA and Antengene sign development and manufacturing agreement
24 Jul 2018
WuXi STA chosen for its end-to-end CMC platform for new drug development.Read more
ProBioGen and Pionyr initiate 2nd immuno-oncology contract development and manufacturing project
18 Jul 2018
Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline.Read more
New screening company exploits the latest advances in microfluidics and 3D culture
19 Jul 2018
The ability to micro size drug-cell interactions will allow pharmaceutical and biotech companies to do 100x more testing for the same money spent as well as increasing productivity.Read more
Natural lipid acts as potent anti-inflammatory
10 Jul 2018
Scientists see therapeutic potential against bacteria, viruses.Read more
Plasticell leads gene therapy manufacturing consortium
3 Jul 2018
Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation