Evaluation of the Incidence, Severity, and Mortality Rate of COVID-19 in Patients with Multiple Sclerosis Receiving Interferon β-1a

We enthusiastically read Payandemehr et al.’s study, which examined the effect of interferon β-1a (ReciGen, CinnaGen Co., Iran) on the severity of the disease in patients with COVID-19 and revealed that taking interferon β-1a (INF) significantly reduced the duration of hospitalization and the rate of mortality of hospitalized COVID-19 patients. INF is one of the main drugs in patients with relapsing-remitting multiple sclerosis (RRMS), and these patients mainly use this drug for a long time. We decided to examine whether the drug has an effect on the incidence rate of COVID-19 in MS patients and whether it affects the course of COVID-19 in case of infection. In November 2020, 75 RRMS patients treated with INF (ReciGen, CinnaGen Co., Iran) were evaluated for COVID-19. Fifty-seven and eighteen cases were female and male, respectively. Patients had a mean age of 36.9±7.2 years, disease duration of 7.0±4.4 years, and the INF use duration of 3.5±1.7 years. Of these 75 patients, only one patient (1.33%) tested positive for COVID-19. The patient was a 29-year-old female nurse working in the pediatric intensive care unit (ICU) and had been receiving INF for six years since the diagnosis of MS. She developed symptoms of cough, shortness of breath, lethargy, anorexia, constipation, and diarrhea in June 2020. The lung computed tomography (CT) scan indicated mild lung involvement, and the reverse transcription polymerase chain reaction (RT-PCR) test was positive for COVID-19. The patient continued her INF treatment, and the symptoms completely disappeared after five days. The patient did not require to be hospitalized during her COVID-19 infection. Therefore, the hospitalization rate due to COVID-19, hospitalization in the ICU, and mortality rate were zero in INF users. In a study by Sahraian et al. addressing 4647 MS patients revealed that the incidence of COVID-19 was 1.46%, which was similar to our findings concerning patients receiving INF. However, the hospitalization rate in the mentioned study was 25%, which was very different from that of our study. It should be noted that patients were taking a wide range of drugs in the mentioned study, and most of them were taking rituximab. Nevertheless, there was no relationship between the type of the administered drug and the chance of hospitalization in the mentioned study. Our findings suggest that there might be a link between the use of INF and non-hospitalization and lack of mortality in patients with MS infected by COVID-19. The obtained findings are in line with the results provided by Payandemehr et al.’s study. Although our study was observational and did not have a control group, it revealed that the INF administration might reduce the severity of the infection. However, the use of INF did not prevent COVID-19 infection. The positive effect of interferons on reducing the severity of COVID-19 has been indicated in other studies, as well. Considering its positive effect on COVID-19 and the fact that interferons have been used in the treatment of MS disease for many years, more attention should be devoted to administering this drug in patients with MS during COVID-19 as it can significantly reduce the risk of COVID-19 related complications

Could Fampridine Attenuate the Severity of COVID-19 in Patients with Multiple Sclerosis?

Since the onset of COVID-19 in December 2019, millions of people have been infected with SARS-CoV-2 across the world and many have died of the disease. Therefore, the search for any drug with a positive effect on the course of this disease is of great value. Fampridine is a drug widely used to improve gait disorders in patients with multiple sclerosis. The mentioned drug is a potassium channel blocker that increases the conduction of action potentials in damaged axons. However, it is not evident whether this drug can affect potassium channels on the surface of other cells. Some studies have revealed that potassium-blocking drugs can play a role in reducing the incidence or severity of infectious diseases. Hence, the question of whether fampridine could also have a protective effect on patients with MS in the face of COVID-19 should be attended to. The incidence and severity of COVID-19 in patients with MS receiving fampridine (Dalfyra®, Arvand Pharmed) were evaluated to address the mentioned question. In the present study conducted in November 2020, 117 MS patients receiving fampridine were tested for COVID-19. The majority of these patients (55.6%) were receiving rituximab. Of these 117 patients, nine were infected by the COVID-19 virus. Of these nine patients, five and four were female and male, respectively. Eight of the infected patients took rituximab, and one did not take any disease modulatory drug (DMD). One of these nine patients required to be hospitalized. She was a 40-year-old woman with MS disease duration of 3.5 years and was treated with rituximab. Her symptoms were manifested by fever, shortness of breath, and dry cough. The mentioned patient was hospitalized for three days due to the conditions associated with COVID-19. She did not need to be admitted to the intensive care unit (ICU) and was discharged with a good medical condition after three days. The incidence of COVID-19 in these patients was 7%, and the hospitalization rate was 11% in patients receiving fampridine. None of the patients with COVID-19 required hospitalization in the ICU, and no fatalities were reported. In a previous study conducted on 4,647 patients with MS in Iran, the incidence rate was reported to be 1.46% during the first wave of COVID-19 (May 2020). The incidence rate in our study was 7%, which was significantly higher than the percentage of the previous report. It should be noted that our study was conducted at the height of the second wave of COVID-19 in Iran, during which a much larger number of people were infected with COVID-19, according to official statistics. In the previous study, the hospitalization rate was 25%. However, fampridine users, despite being more infected, had a lower hospitalization rate (11%), which indicated a lower severity of the disease in these patients. The mentioned finding could be due to the possible protective effect of fampridine on the exacerbation of COVID-19 in these patients. This hypothesis requires further examination in more detail

A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy

Background Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non–small cell lung cancer, and prostate cancer. Objective This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel. Methods Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets. Findings A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants’ mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens. Conclusions The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc

A Phase IV Study of the Safety and Efficacy of CinnoPar® in Iranian Patients with Osteoporosis

The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar®, has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 μg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant (p<0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients

Pregnancy outcome in patients with multiple sclerosis treated with Rituximab: A case-series study

No abstract availabl