PLUS: PBS listing now live for ILD drug; fat injections help hand OA; JAKi–BTK inhibitor combo on trial in RA; and HCQ now unrestricted.
The latest GRA research has good news for patients, with flares reassuringly uncommon. But potential risk factors need further investigation.
Plus:
- Flare rates reassuringly low after covid vax
- Nintedanib PBS listing goes live
- JAKi–BTKi combo no better than JAKi alone for RA
- Fat injections help hand OA
- Hydroxychloroquine streamline code gone
Flare rates reassuringly low after covid vax
An online survey of over 5000 adults with systemic rheumatic disease has found that only 4.9% reported flares requiring a change in treatment following covid vaccination. However, there were some differences depending on the vaccine received and disease type, as well as other potential risk factors.
Conducted by the COVID-19 Global Rheumatology Alliance (GRA), the survey was available in multiple languages and promoted through patient groups and social media. Respondents were asked if they’d had any serious reaction to the covid vaccine lasting at least two days and occurring within two months of receiving the vaccine.
The primary outcome was self-reported flare of an existing systemic rheumatic disease requiring a change in treatment, such as increased medication dose or adding a new medication. The findings were published in Rheumatology.
Flares were almost three times more commonly reported by females than males (OR 2.71). Respondents with lupus (OR 1.51), psoriatic arthritis (OR 1.95) and polymyalgia rheumatica (OR 1.94) reported a higher flare rate than those with rheumatoid arthritis, while those with myositis (OR 0.54) reported a lower prevalence.
Respondents who’d previously experienced a serious reaction to other non-covid vaccines reported higher rates of flare. Those who’d received the Oxford-AstraZeneca vaccine were more likely to report flares than those who’d received Pfizer-BioNTech or Moderna vaccines.
Information about disease activity at the time of vaccination, severity of flare, flare history, and medication timing and withholding was lacking, and background flare rate was unquantified. Other limitations were the self-reported data without medical verification in a volunteer sample with potential self-selection bias.
The authors suggested population-based and prospective clinical studies are needed to confirm and extend the findings.
Rheumatology 2022, online 23 April
Nintedanib PBS listing goes live
Nintedanib (Ofev – Boehringer Ingelheim) is now available on the PBS for progressive fibrosing interstitial lung disease. Initial treatment is written authority, with continuing online.
The drug was recommended for an authority required (written) listing for the treatment of patients with progressive fibrosing interstitial lung disease at the September 2021 intracycle meeting. The manufacturer had submitted the drug for consideration in March 2021, but it was not recommended for this indication due to concerns about cost effectiveness vs placebo plus best supportive care.
In recommending it, PBAC noted “the remaining uncertainty around the cost-effectiveness of nintedanib could be adequately managed by a price reduction.”
JAKi–BTKi combo no better than JAKi alone for RA
In the quest for treatment options for RA patients who don’t respond to treatment with methotrexate alone or in combination with biologics or JAK inhibitors, a novel Bruton’s tyrosine kinase (BTK) inhibitor, elsubrutinib, was tested individually and in combination with JAK inhibitor upadacitinib.
The phase 2 multicentre, double-blind randomised controlled trial, sponsored by AbbVie, assigned 224 RA patients to receive various doses of elsubrutinib alone, upadacitinib, a combined elsubrutinib-upadacitinib dose called ABBV-599 and placebo.
Patients had active disease, and inadequate response to or intolerance of biologics. The primary endpoint was change from baseline in disease activity score of 28 joints with C-reactive protein (DAS-28) at week 12.
Compared with placebo, there were significant improvements in the upadacitinib-alone and the ABBV-599 groups. However, there were no significant improvements for any of the elsubrutinib-only doses, leading the authors to suggest that ABBV-599 efficacy was driven exclusively by upadacitinib.
“Although these results provide additional support for the clinical benefits of JAK inhibition by upadacitinib in patients with rheumatoid arthritis, our results do not support the addition of a BTK inhibitor to a JAK inhibitor-based regimen for rheumatoid arthritis,” the authors concluded.
Lancet Rheumatol 2022, online 27 April
Fat injections help hand OA
A long-term follow up of patients receiving autologous fatty tissue injections into arthritic finger joints has shown promising results, according to a paper published in Plastic and Reconstructive Surgery.
While surgery can provide effective relief from pain, complications include reduction in strength, prosthetic loosening or dislocation, infections and long down time in recovery. Hence there is a need for minimally invasive treatments that provide lasting pain relief, and improved strength, mobility and function, the authors wrote.
In the study, which was intended as a pilot, 18 patients for whom conventional therapies were unsuccessful were administered a fat transfer from the upper thigh into affected finger joints. Studies have shown that there is a high concentration of pluripotent mesenchymal stromal cells in fatty tissue, and that these cells can transform into local tissue.
Strength, hand function and pain levels were measured before and after the transfer.
After an average 44 months of follow up, force of pinch grip and pain were significantly improved. Improvements in hand function, as measured by the Disabilities of the Arm, Shoulder and Hand questionnaire, and force of fist closure were non-significant.
“Even over a long-term study period, the transfer of fatty tissue to arthritic finger joints has shown itself to be a minimally invasive, safe and promising alternative treatment to conventional surgical procedures that offers significant improvements in terms of osteoarthritis symptoms,” concluded the authors, adding that because this method preserves the joint, surgery remains an option further down the track.
Larger, controlled studies are needed, said the authors.
Plastic and Reconstructive Surgery May 2022, 149 (5) 1139-45
Hydroxychloroquine streamline code gone
The PBS has removed the need for streamline codes when prescribing hydroxychloroquine. The measure, adopted at the start of the pandemic when hydroxychloroquine shortages were precipitated by perceived benefit for treating covid, has now been removed in the latest PBS update on 1 May and it’s now unrestricted.
Hydroxychloroquine has been readily available for some time, and one tonne of unrequited, unregistered hydroxychloroquine (of uncertain manufacturing origin) imported by Clive Palmer was left unclaimed in a Melbourne warehouse and was destroyed last year.
