News in brief: Pharmacists concern over biosimilar switching letters; JSLE patients have neuropsychiatric symptoms; Aussie trial confirms convalescent plasma is futile for COVID-19 patients

11 Oct 2021

Pharmacists concern over biosimilar switching letters

Pharmacists have raised concerns about some rheumatologists who they claim are giving patients proforma letters supplied by Abbvie insisting that the originator Humira brand of adalimumab is dispensed rather than biosimilars.

According to a report in The Australian, pharmacists said they felt it was inappropriate for doctors to use letter templates saying the prescriber had determined that brand substitution was not clinically appropriate for the patient and that no other brand of adalimumab should be dispensed in place of Humira.

However the paper quoted specialists saying that they may not be comfortable with patients switching back and forth between Humira and biosimilars, on safety grounds.

Dr Susanna Proudman,  a rheumatologist at the Royal Adelaide Hospital, said patients needed consistency and “rheumatologists and consumers may argue the clinical decision about what drug is prescribed should be the drug that is dispensed – and if that is not happening, some form of correspondence is entered into that may be justified.”


Juvenile-onset lupus patients have neuropsychiatric symptoms

A quarter of patients with juvenile-onset systemic lupus erythematosus (JSLE) experience neuropsychiatric involvement, and in half of cases symptoms are already present at diagnosis, suggest findings of a UK study published in the journal Lupus.

A research team, which included Consultant Paediatric Rheumatologist Dr Eslam al-Abadi, from Birmingham Women’s and Children’s NHS Foundation Trust, looked at data from the UK JSLE Cohort – a network set up in 2006 with the aim of determining the clinical characteristics of patients across the country.

From a cohort of 428 JSLE patients selected for further study, the researchers found no significant differences regarding age at disease onset and/or diagnosis, ethnicity, gender, or family history for autoimmune diseases when comparing those with and without neuropsychiatric involvement.

The majority of neuropsychiatric manifestations (92.7%) involved the CNS, and headaches (78.5%) were the most frequently observed potential symptom of neuropsychiatric SLE. Mood disorder (48.6%) was the second most common, followed by cognitive dysfunction (42%), anxiety disorder (23.3%), seizures (19.6%), movement disorders (17.7%), cerebrovascular disease (14.9%), mononeuropathy (8.4%), acute confusional state (6.5%), psychosis (9.3%) and cranial neuropathy (5.6%).

Of the 107 patients with neuropsychiatric SLE, 15.8% experienced one neurological manifestation (other than isolated headaches, mood disorder, and/or anxiety), 14% experienced two, 23.3% experienced three, 19.6% experienced four and 27% had five or more.

The researchers also found that neuropsychiatric SLE was linked with increased disease activity (pBILAG, and CRP elevation) and damage (as determined by the SLICC-SDI index) “that may contribute to increased mortality”.

They suggested that in order to avoid diagnostic and therapeutic delay, neuropsychiatric involvement “should be considered in all JSLE patients, including testing for cognitive impairment,” and called for future studies with international collaboration “focusing upon the impact of NP involvement on treatment response, permanent damage, and quality of life”.


Aussie trial confirms convalescent plasma is ‘futile’ for critically ill COVID-19 patients

Convalescent plasma does not improve outcomes in critically-ill COVID-19 patients, according to an international study that included Australian centres.

A clinical trial of two units of high-titre, ABO-compatible convalescent plasma in 1,990 critically-ill adults with COVID-19 found plasma use made little difference to patients’ median number of organ support-free days (0, IQR: -1–16 vs 3, IQR: -1–16).

Patients also had similar in-hospital mortality rates (37.3% vs 38.4%) and median number of days alive and off organ support (14, IQR: 3–18 vs 14, IQR: 7–18), regardless of plasma use, the REMAP-CAP study investigators wrote in JAMA, noting that the treatment’s probability of futility was 99.4%.

Additionally, plasma recipients had a higher rate of serious adverse events than non-recipients (3.0% vs 1.3%).

The authors said the results were consistent with convalescent plasma’s lack of benefit for hospitalised patients with moderate or severe COVID-19, as reported in the RECOVERY trial, and suggested there was little-to-no point in offering the treatment for that indication.

The REMAP-CAP study was conducted at multiple global centres with participants from Monash University, Monash Health and Alfred Health, Melbourne University, the Australian Red Cross Lifeblood, Sydney and Perth; Western Sydney University, St John of God Hospital, Perth and the University of Western Australia.

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