About three-quarters of patients remained in treatment with baricitinib (Olumiant) per rheumatoid arthritis after its first 6-month evaluation in an independent analysis of data from the British Society for Rheumatology Biologics Register (BSRBR).
The follow-up rate was even higher, almost 85%, in patients who had not been previously treated with a biologically or targeted synthetic disease-modifying antirheumatic drug (b / ts DMARD) before receiving baricitinib. The 6-month follow-up rate was also higher, with 80%, in patients receiving baricitinib without additional DMARD or steroid therapy.
Overall, the disease activity score in 28 joints using the erythrocyte sedimentation rate score (DAS28-ESR) was reduced from a baseline of 5.7 to 3.4, with similar reductions. observed among subgroups of patients who had received baricitinib as monotherapy, after previous b / tsDMARDs, or without previous b / tsDMARDs.
“We studied an RA study population with data from the BSR biological registry, to try to see how patients with baricitinib are being treated and how they are doing in this real environment, in the UK.” explained the rheumatologist consultant Christopher J. Edwards, MD, from University Hospital Southampton (England) at the annual conference of the British Society for Rheumatology.
“Overall, the effectiveness and tolerability seem to be pretty good,” he said. “The sample size, of course, was small and it will be good to see a little more data collected over time that will allow us to have more confidence in the conclusions.”
‘ How to get to Grips ‘ With Baricitinib
Baricitinib is a drug with which doctors in the UK “are only taking control,” he noted Jon Packham, BM, DM, a rheumatologist consultant at Haywood Hospital in Stoke-on-Trent (England) who did not participate in the analysis.
“We look forward to having a few more patients in this 6-month hurdle and receiving even more data,” Packham said.
Baricitinib was administered marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition to the BSRBR-RA, which has been running for 20 years. It includes data on patients with RA who have just started a bDMARD or tsDMARD, and patients are monitored every 6 months during the first 3 years of treatment and subsequently every year.
Edwards data presented on some of the baseline characteristics and condition of patients in the first 6-month follow-up of BSRBR-RA. It was clear that this analysis was done independently of the BSRBR-RA study team and was conducted under an agreement between Eli Lilly and the BSR to allow access to the data.
Between 1 January 2018 and 31 March 2019, there were 409 patients starting treatment with baricitinib who had been admitted to the BSRBR-RA. The mean age of the patients was 61 years and the majority (76%) were women. On average, patients starting with baricitinib had been diagnosed with RA for 11 years and 62% had been previously treated with biologics.
According to the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), and 40% of patients were receiving it in combination with methotrexate. About 38% of patients received baricitinib as monotherapy and just under 30% received concomitant glucocorticoids.
Most (84%) were prescribed a daily dose of 4 mg of baricitinib, and the rest with a daily dose of 2 mg.
There were 163 patients with data available during the first 6-month follow-up and, of these, 103 had previous experience of being treated with DMARD ab / ts, 59 had not and 65 had received baricitinib as monotherapy.
Reasons for suspension
Overall, about a quarter of patients discontinued baricitinib treatment and “the reasons for this were lack of efficacy in about a quarter and adverse events in about two-thirds of patients,” he said. dir Edwards.
The decomposition of adverse event types was not part of this analysis and it is likely that this information came directly from the BSRBR-RA study team.
“We have experience in our practice in Southampton,” Edwards noted. This experience was outlined in one separate summary at the meeting and presented by May Nwe Lwin, clinical researcher of the Edwards group.
Lwin presented data on 83 patients who had received baricitinib at Southampton University Hospital between October 2017 and July 2020, 55 (65.2%) of whom remain in treatment to date, with a mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.
“Patients who continued with baricitinib appeared to be more likely to be older and female,” Lwin said.
The mean age of patients who continued treatment after 12 months was 61.5 years, but it was 49 years for those who stopped earlier. The percentage of women who continued treatment at 12 months compared to those who stopped earlier was 82% and 67%. Both findings were significant (Pg <.001) but "could mean nothing, or could be very interesting data to explore further," Lwin suggested.
“However, there were no significant differences in discontinuity rates for those using mono- or combination therapy, nor was there any effect on disease duration or seropositivity,” Lwin said.
“Most people stopped baricitinib during the first three months of treatment,” reported Lwin, who noted that the most common reason was lack of efficacy in 64% of patients, with 28.5 % of patients who stopped producing due to side effects.
“When we look at adverse events, the reasons for the suspension are quite variable,” Lwin said. These included infections (one urinary tract infection, two chest infections, and one urinary tract infection) and one case each. discitis, impaired liver function, lymphoma, and personality change.
Long-term security profile update
Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and a long-term extension study.
“We recently published a long-term safety analysis of this molecule involving more than 3,700 patients with an exposure of up to 7 years, ”he said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.
Winthrop has provided an update on this, adding 13,148 more patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.
“In short, not much has changed,” Winthrop said, noting that event rates have remained stable.
The major and most general adverse cardiovascular event (MACE) deep vein thrombosis/pulmonary embolism the event rate was 0.5 per 100 patient-years. In reference to the latter, Winthrop called them “rock solid stable” and “has been like that really throughout the development program.”
In general, event rates per 100 patient-years for severe infections, shingles, i tuberculosis they were 2.7, 3.0, and 0.2, respectively. Severe infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Winthrop said. “I would just say it’s similar to what we see with all the biological and small molecules in this environment.”
Malignancy and mortality rates were also higher in older patients, but after age adjustment, these had been stable at different points of analysis.
“General malignancy, excluding NMSC [nonmelanoma skin cancer], the percentage of events is 0.9 per 100 patient-years, very similar to what we have seen in previous data cuts, “he said.” The same goes for lymphoma, ”he added, with an overall event rate of 0.1 per 100 patient-years.
This updated analysis, Winthrop concluded, “suggests a really similar security profile to the one recently published.” The analysis of the BSRBR-RA data he presented was sponsored by Eli Lilly and was conducted independently of the BSRBR-RA study team. Packham did not report any conflicts of interest; chaired the oral summary sessions in which Edwards presented his findings.
Lwin did not report any disclosures.
Winthrop has acted as a consultant for Eli Lilly and several other pharmaceutical companies and had received research or grants from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.
This article originally appeared on MDedge.com, which is part of the Medscape professional network.