mac pulmonary infection :: Article CreatorMAC-PD Mortality During Treatment Predicted By Erythrocyte Sedimentation Rate
Mortality during treatment for Mycobacterium avium complex pulmonary disease (MAC-PD) was predicted by an increased erythrocyte sedimentation rate (ESR), investigators reported in Therapeutic Advances in Respiratory Disease.
Researchers at a university hospital in Korea conducted a retrospective cohort study to assess how ESR changed over time in response to MAC-PD treatment and the value of ESR as a prognostic biomarker.
The study enrolled patients aged 18 years and older who initiated anti-mycobacterial treatment for MAC-PD between January 1, 2009, and March 31, 2022. All participants had ESR measured at least twice, with a minimum interval of 3 months, in the initial 12 months from commencement of antibiotic treatment. The participants were classified into 2 groups based on their culture conversion status 12 months post treatment initiation and were followed up until May 31, 2022. ESR values were estimated every 3 months and compared within each group and between groups.
The analysis included 369 patients. Their mean (SD) age was 63.5 (10.7) years, and 113 (30.6%) were male. The mean ESR at treatment initiation was 36.3 (29.0) mm/h, and the median follow-up was 45.5 months (interquartile range, 28.0-92.8 months). A total of 51 patients (13.8%) died, with a mortality rate of 7.29 deaths per 100,000 person-years.
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Our results underscore the importance of administering anti-mycobacterial treatment even in patients who did not achieve a microbiological cure.
Increased ESR levels during the treatment process and at treatment initiation were associated with a greater risk of mortality (adjusted hazard ratio, 1.03; 95% CI, 1.02-1.03), after adjustment for age, sex, body mass index, comorbidities, presence of cavity, acid-fast bacilli smear positivity, and culture conversion at 12 months.
The investigators examined whether patients' ESR increased or not after treatment initiation. They found that the probability of survival significantly increased among patients in whom the ESR did not increase (log-rank P =.031). ESR levels were significantly increased in individuals who did not survive compared with those who did survive during the full 12-month treatment period (P <.001).
Culture conversion occurred in 64.0% of patients (culture-converted group, n=236), and 36.0% did not achieve culture conversion (not-converted group, n=133). A trend toward reduced ESR was seen in both the culture-converted and not-converted groups throughout the treatment period. In the culture-converted group, ESR at 12 months of antibiotic treatment was significantly reduced compared with baseline mean of 36.3 to 22.2 (95% CI, 17.9-26.6; P <.001). In the not-converted group, the ESR level at 12 months of treatment also was reduced significantly vs baseline, to 24.8 (95% CI, 18.8-30.8; P <.001). No significant differences occurred in ESR between groups at each time point.
Among several limitations, long-term treatment outcomes were not assessed, and analysis to calculate sample size was not performed owing to the retrospective cohort design. In addition, ESR was not routinely measured from the time of treatment initiation.
"Our results underscore the importance of administering anti-mycobacterial treatment even in patients who did not achieve a microbiological cure," the study authors stated.
Insmed's Q3 Loss Wider Than Expected, Sales In Line With Estimates
Insmed INSM reported a third-quarter 2024 loss of $1.27 per share, wider than the Zacks Consensus Estimate of a loss of $1.19. In the year-ago quarter, the company posted a loss of $1.11 per share.
Insmed generated total revenues of $93.4 million during the quarter, up 18% year over year. Quarterly sales were in line with the Zacks Consensus Estimate.
Shares of INSM were down more than 4% on Thursday likely due to the earnings miss.
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Year to date, shares of Insmed have surged 117.1% against the industry's 3.6% decline.
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In the reported quarter, total revenues were generated entirely by its only marketed drug, Arikayce, which is approved for treating refractory mycobacterium avium complex (MAC) lung disease in adults with limited or no alternative treatment option.
The rise in Arikayce sales was driven by continued growth in demand across all marketed regions. Sales of the drug increased 13% to $66.9 million in the United States, while that in Japan rose 31% to $21.0 million. Sales in Europe and the rest of the world rallied 45% to $5.6 million.
In the reported quarter, research and development (R&D) expenses rose 38% year over year to $150.8 million. Selling, general and administrative (SG&A) expenses amounted to $118.9 million, up 31% from the year-ago figure. The uptick in both expenses is attributable to an increase in employee compensation and benefit-related expenses.
As of Sept. 30, 2024, Insmed had cash, cash equivalents and marketable securities of around $1.5 billion compared with $1.2 billion as of June 30, 2024. This surge in cash balance was due to the inflow of funds from the company's at-the-market equity program, which added net proceeds of $371 million during the third quarter.
Management reiterated its sales guidance for the full year. It expects product sales for Arikayce to be between $340 million and $360 million, indicating 15% year-over-year growth at the midpoint of the range.
Alongside the earnings release, Insmed announced that it is scheduled to meet the FDA before this year's end to discuss the possibility of an accelerated approval to expand Arikayce's label to treat all patients with MAC lung infection. In this regard, management is conducting the phase III ENCORE study, which is evaluating the drug as a potential treatment for newly infected patients with MAC lung disease.
If the FDA approves Arikayce's label for newly infected patients with MAC lung disease, it will significantly expand the drug's patient population. Management estimates the total addressable market (TAM) for refractory MAC to be around 30,000 patients in the United States, Europe and Japan. If the drug was also approved in the newly-infected patient population, the TAM would increase to around 275,000 patients in the combined markets. Based on these factors, we expect the drug to generate more than $1 billion in peak sales.
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Insmed remains on track to submit a regulatory filing for brensocatib in bronchiectasis before the end of this year. If approved, brensocatib will be the first approved treatment for bronchiectasis patients. Management expects a commercial launch for the drug in the United States in mid-2025 (assuming priority review), followed by product launches in Europe and Japan in the first half of 2026.
Apart from bronchiectasis, Insmed is also evaluating brensocatib in the phase IIb BiRCh study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP). A data readout is expected in the second half of 2025. Management also intends to initiate a mid-stage study on the drug in HS indication before 2024-end.
Management expects to report top-line data from a mid-stage study evaluating treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) in the second half of 2025. It also plans to start a late-stage study next year evaluating TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Insmed currently has a Zacks Rank #3 (Hold).
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Some better-ranked stocks from the sector are Amicus Therapeutics FOLD, Elevation Oncology ELEV and Castle Biosciences CSTL. While FOLD and ELEV sport a Zacks Rank #1 (Strong Buy) each at present, CSTL carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here.
In the past 60 days, estimates for Amicus Therapeutics' 2024 earnings per share (EPS) have moved up from 21 to 22 cents. EPS estimates for 2025 have increased from 50 to 53 cents during the same period. Year to date, shares of FOLD have lost 18.4%.
FOLD's earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 23.96%.
In the past 60 days, estimates for Elevation Oncology's 2024 loss per share have narrowed from 86 to 82 cents. Loss per share estimates for 2025 have narrowed from 90 to 86 cents during the same time. Year to date, shares of ELEV have rallied 11.7%.
ELEV's earnings beat estimates in three of the trailing four quarters and missed the same in one, the average surprise being 12.05%.
In the past 90 days, estimates for Castle Biosciences' 2024 loss per share have narrowed from $1.28 to 59 cents. Year to date, shares of Castle Biosciences have surged 60.1%.
CSTL's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 132.32%.
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Doctor Explains If Your Cough Is A Cold, Covid Or Something Deadly
It's that time of year again when many of us seem to be ill in some form. With the UK Health Security Agency (UKHSA) reporting cases of flu, Covid and respiratory syncytial virus (RSV), as well as norovirus across the country, it can be hard to know exactly what is wrong.
With this in mind an expert revealed how to distinguish certain coughs and what could be causing them. Doctor Malathy Munisamy, a clinical research physician at MAC Clinical Research, also warned that a cough that persists for weeks could be a sign of something even more serious.
Dr Munisamy explained: "If your cough lasts three weeks or more, you should book a visit to see your GP. Standard coughs, which are often 'harmless', settle on their own within a couple of weeks.
"A cough is simply the body's natural response to any irritations within the airways. Coughs can be categorised into three groups; acute, subacute, and chronic."
He added: "Any cough with associated worrying or severe symptoms such as coughing up blood, hoarseness of the voice, shortness of breath, fever, weight loss, trouble swallowing, or vomiting, should immediately be assessed by your doctor or GP."
A cough accompanied by a headache could mean you have a cold or Covid (
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Getty) Colds and flu
Dr Munisamy said if your cough is caused by a cold or flu it could be accompanied by yellow phlegm, as well as:
Headaches Muscle aches Sneezing Increased temperature/fever. He advised: "As this cough is caused by a virus, rest, hydration, paracetamol, ibuprofen or cold relief medication are usually effective treatments. If you are taking antibiotics for viruses, these will not work and could lead to bacterial antibiotic resistance."
Chest infections
A chest infection will be distinguishable by a chesty cough as well as:
Wheezing, shortness of breath and chest pain High temperature, aching muscles, fatigue and headaches Lots of dark yellow or green mucus. "Chest infections can either be viral or bacterial, both are treated with different medications," he said. "Either antiviral medication or an antibiotic can be prescribed alongside the usual advice of rest, paracetamol, and hydration."
Covid
He advised that a cough caused by Covid will often be a new continuous cough, which means you cough a lot for more than an hour or have three or more coughing episodes in 24 hours. You might also have:
A high temperature A loss or change to your sense of smell or taste Shortness of breath and/or a sore throat Tiredness, runny nose, diarrhoea. To treat it Dr Munisamy said: "While there are vaccinations against developing severe symptoms of Covid, treatment is mostly the same as when you have a cold or flu; staying hydrated, getting lots of sleep, and paracetamol for when you feel uncomfortable."
Pneumonia
He advised that symptoms of pneumonia include:
A wet cough, sometimes with foul-smelling green or yellow mucus Shortness of breath, chest pain, and a wheezing noise when you breathe A high temperature Aches and pains and feeling very tired Loss of appetite. "Pneumonia is usually caused by a bacterial or viral infection, much the same as a chest infection, but the infection and its symptoms are much more severe," he said.
To treat it hydration and medication, such as antibiotics or antivirals, is recommended, but if you are at risk of serious illness, (for instance, if you are over 65), have cardiovascular disease, a lung condition, or if it is your baby or child that has pneumonia, you may need to go to hospital to receive further treatment and oxygen.
Coughing up blood could be a sign of something more serious like lung cancer (
Image:
Getty) Chronic obstructive pulmonary disease (COPD)
This falls into the chronic category and can include:
Shortness of breath and a persistent cough Wheezing and chest tightness Fatigue and frequent respiratory infections Increased amounts of mucus, commonly coloured brown. COPD is a term given to a group of lung conditions including bronchitis and emphysema. Prolonged or long-term exposure to damaging irritants, such as smoking, dust, chemicals, and fumes are the primary cause of COPD.
Dr Munisamy said: "There is currently no cure for this progressive illness, but there are lifestyle changes which can help ease symptoms and aim to prolong life expectancy. These include stopping smoking, bronchodilators, inhaled corticosteroids, pulmonary rehabilitation, and oxygen therapy. Speak to your doctor or GP about the options available."
Idiopathic pulmonary fibrosis (IPF)
Another chronic condition, this can cause:
Shortness of breath and a persistent dry, hacking cough Chest discomfort or chest pain Fatigue and unintentional weight loss Clubbing of the fingers and toes Producing a brown or red-tinged phlegm. The cause of pulmonary fibrosis is unknown, however, there are several theories proposed for contributing to the development of IPF, such as long-term exposure to various environmental agents, including dust, pollutants, and certain occupational hazards, genetic factors and potentially some viral infections.
Treatments include medications, supplemental oxygen, pulmonary rehabilitation, and, in some cases, lung transplantation.
Lung cancer
With 34,800 deaths per year, lung cancer is the UK's biggest cancer killer. In 72 per cent of cases, lung cancer is caused by smoking alone.
Symptoms include:
Constant coughing and shortness of breath May also experience shoulder pain, loss of appetite, weight loss, or pain when you take in a deep breath Coughing up blood or a pink/red phlegm. Dr Munisamy added: "If you are worried about a new persistent cough, or you're concerned that the symptoms described above fit with your condition, then do consult your GP or doctor at the earliest opportunity."
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