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PurposeTo evaluate the clinical feasibility and tolerability of large volume subcutaneous delivery at different injection depths for lean and non-lean subjects.MethodsA single-center, randomized, subject-blinded, crossover study in 62 healthy subjects was conducted to evaluate delivery of a 10-cP solution containing hyaluronic acid. Subjects were separated into lean and non-lean cohort by SC thickness. A syringe pump was used to study the effect of different volumes (5, 12, 25 mL) of a viscous placebo solution and needle lengths (6, 9 and 12 mm) delivered at 0.5 mL/min.ResultsAcross all treatments, injection sites were observed to have negligible leakage, ~34 kPa of back pressure, and VAS of mild pain with higher pain from needle insertion than during injection. While mild to moderate erythema was the most frequently reported ISR and edema was most prominent for 25 mL injections, all ISRs were resolved within 4 hours post injection. Subjects were unbothered by ISRs across all treatments and rated them as low distress scores (average 1.0–1.5 out of 6).ConclusionSC injection of 25 mL is feasible and tolerable using a low-pain formulation for abdomen injection irrespective of subcutaneous thickness and injection depths at a delivery rate of 0.5 mL/min.

•These data provide a comprehensive overview of the safety profile of RZV from two pivotal phase 3 studies.•A favourable benefit-risk profile of RZV was demonstrated.•This overview will help healthcare practitioners in making informed clinical decisions. The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

The Pfizer-BioNTech COVID-19 vaccine has recently received emergency approval from the US FDA. The mRNA technology was used to manufacture the Pfizer vaccine; however, as a pioneering technology that has never been used in the manufacture of vaccines, many people have concerns about the vaccine's side effects. Thus, the current study aimed to track the short-term side effects of the vaccine. The information in this study was gathered by a Google Form-questionnaire (online survey). The results included the responses of 455 individuals, all of whom are Saudi Arabia inhabitants. Adverse effects of the vaccine were reported after the first and the second doses. The most common symptoms were injection site pain, headaches, flu-like symptoms, fever, and tiredness. Less common side effects were a fast heartbeat, whole body aches, difficulty breathing, joint pain, chills, and drowsiness. Rare side effects include Bell's palsy and lymph nodes swelling and tenderness. Flu-like symptoms were more common among those under 60 years of age, while injection site pain was more frequent among recipients who were 60 years and older. The study revealed a significant increase in the number of females who suffered from the vaccine side effects compared to males. Difficulty of breathing was more reported among recipients who had been previously infected with the coronavirus compared to those who had not been previously infected. Most of the side effects reported in this study were consistent with Pfizer's fact sheet for recipients and caregivers. Further studies are required to determine the long-term side effects.

Injection-site pain (ISP) is a subjective side effect that is commonly reported with the subcutaneous administration of biological agents, yet it may only be a concern to some. Multiple factors related to the product formulation, such as pH, volume and excipients, and/or to the injection process have the potential to contribute to ISP, while patient-related factors, such as low body weight, gender and age, can make an individual more susceptible to experiencing ISP. While total elimination of ISP remains unlikely with any subcutaneously administered agent, it can be minimised by helping the patient to develop a confident and competent injection technique via robust and effective training. Careful management of patient expectations along with open discussion regarding the potential risk of ISP may serve to minimise treatment-related anxieties and, importantly, allow the patient to remain in control of his/her treatment. Other interventions to help minimise ISP include psychological interventions, allowing biologics to reach room temperature prior to injection, using the most suitable injection device for the individual patient and selecting an alternative drug formulation, when available. Productive patient–physician communication remains important in order to support and optimise treatment experience and adherence, while also providing the opportunity for patients to discuss any ISP-related issues.

BACKGROUND: Scalp platelet-rich plasma (PRP) mesotherapy is commonly used to increase hair density and improve scalp health in patients with androgenetic alopecia. While PRP therapy is favored for its lower risk of adverse effects and reduced treatment frequency compared to other methods, the potential for injection site pain remains a significant challenge, potentially reducing patient compliance and treatment continuation. OBJECTIVE: To evaluate the effectiveness of local skin precooling in reducing injection site pain during scalp PRP mesotherapy in patients with androgenetic alopecia. STUDY DESIGN: A single-center retrospective study. SETTING: This study was conducted at the Precision Health Management Center of the Shanghai East Hospital, Tongji University School of Medicine, People’s Republic of China. METHODS: Data were collected from 100 patients (82 men, 18 women) aged 18-50 years who underwent scalp PRP mesotherapy from August 2020 through July 2024. Patients were divided into 2 groups: Group A (n = 50) received local skin precooling administered using sterile gloves by way of soft ice packs for 2 minutes pre scalp nerve block; Group B (n = 50) did not receive local skin precooling pre scalp nerve block. All patients received scalp PRP mesotherapy. Pain perception was measured using a 100-mm Visual Analog Scale (VAS) at multiple time points: 30 seconds post scalp nerve block at 2 nerve points, at immediate posttreatment, and at one- and 24-hours posttreatment. Demographic data and Positive and Negative Affect Schedule scores were also collected. Safety outcomes included the incidence of adverse events. RESULTS: VAS scores were significantly lower in Group A compared to Group B at all measured time points. At 30 seconds post scalp nerve block, Group A showed a 34.08% pain reduction at the supraorbital nerve and the supratrochlear nerve and an 18.86% pain reduction at the greater occipital nerve compared to Group B. VAS scores for Group A at immediate posttreatment, and one and 24 hours posttreatment were significantly lower than those for Group B (P < 0.05). The primary adverse reactions reported were mild. They included headache, injection site pain, and scalp sensitivity, all of which resolved quickly. LIMITATIONS: The retrospective nature of the study, limited data collection, small sample size, and short follow-up period are notable limitations. Larger-scale prospective studies with extended follow-up periods are recommended for future research. CONCLUSION: local skin precooling is a simple and effective technique for reducing injection site pain during a scalp nerve block. PRP mesotherapy, thereby enhancing patient comfort and compliance. Our study is the first to analyze the analgesic effects of local skin precooling on scalp nerve block injection site pain in patients undergoing scalp mesotherapy. KEY WORDS: Mesotherapy, androgenetic alopecia, local skin precooling, injection site pain, scalp nerve block, visual analog scale, pain management

PurposePharmaceutical buffer systems, especially for injectable biologics such as monoclonal antibodies, are an important component of successful FDA-approved medications. Clinical studies indicate that buffer components may be contributing factors for increased injection site pain.MethodsTo determine the potential nociceptive effects of clinically relevant buffer systems, we developed an in vitro multi-electrode array (MEA) based recording system of rodent dorsal root ganglia (DRG) sensory neuron cell culture. This system monitors sensory neuron activity/firing as a surrogate of nociception when challenged with buffer components used in formulating monoclonal antibodies and other injectable biologics.ResultsWe show that citrate salt and citrate mannitol buffer systems cause an increase in mean firing rate, burst frequency, and burst duration in DRG sensory neurons, unlike histidine or saline buffer systems at the same pH value. Lowering the concentration of citrate leads to a lower firing intensity of DRG sensory neurons.ConclusionIncreased activity/firing of DRG sensory neurons has been suggested as a key feature underlying nociception. Our results support the utility of an in vitro MEA assay with cultured DRG sensory neurons to probe the nociceptive potential of clinically relevant buffer components used in injectable biologics.

Biological products administered via subcutaneous (SC) injections offer an effective and convenient alternative to those administered via traditional intravenous injections and have gained a significant increase among approved drugs in recent years. However, SC injections may cause injection site reactions (ISRs) especially injection site pain (ISP). Although usually mild and occurring with variable frequency ranging from about 0.8 to 15.5%, ISRs can degrade patient experience and negatively impact patient treatment adherence. In an effort to prevent unnecessary discontinuation of the treatment, this review article aims to provide an overview of the key risk factors reported in published literature that may contribute to ISRs in SC administered biologics. In addition, mitigation strategies are proposed to help reduce the incidence of ISRs, support the development of well-tolerated SC products, and allow patients to take advantage of the full value of the SC route of administration. Graphical abstract

Background Treprostinil, a prostacyclin analogue, is an effective treatment for pulmonary arterial hypertension (PAH). However, continuous subcutaneous infusion is often complicated by severe injection site pain, which can limit continuation of therapy. Case presentation We report four PAH patients who developed severe injection site pain during subcutaneous treprostinil therapy in the lower abdomen. A hospital-compounded 10% lidocaine gel was applied around the infusion site. Pain was markedly reduced in all cases, with visual analog scale scores improving from 75 to 100/100 to 0–20/100. In two patients, tramadol could be reduced or discontinued, and all patients were able to continue treprostinil therapy without pain-related limitation or treatment interruption. No systemic adverse effects were observed, although one patient experienced mild local skin irritation. Conclusions Topical 10% lidocaine gel provided rapid and effective relief of injection site pain associated with subcutaneous treprostinil, facilitating continuation of therapy without pain-related interruption in patients with PAH.

IntroductionOur aim was to evaluate patient adherence and persistence with citrate-free adalimumab (ADA-CF), introduced in 2018 to reduce injection-site pain, compared with citrate-containing adalimumab (ADA-C).MethodsThis was a retrospective cohort study using a US claims database (IBM® MarketScan® Commercial and Medicare Supplemental Claims Database) from February 2018 to January 2020. Patients at least 18 years of age who were naïve to adalimumab 6 months before the index date (date of first adalimumab claim) and with at least 12 months of continuous medical and pharmacy coverage were eligible for the study. Adherence was assessed by determining the proportion of days covered (PDC) and the percentage of patients with PDC ≥ 80% during the 12-month follow-up period. Persistence was evaluated by measuring the rate of discontinuation and days to discontinuation (i.e., time on treatment) from the index date over the 12-month follow-up period. Continuous adherence outcomes (PDC) were evaluated using linear regression models. Binary adherence outcomes (PDC ≥ 80%) were assessed using logistic regression models. Kaplan–Meier analysis and Cox proportional hazards models were used to assess persistence outcomes.ResultsThere were 2195 and 1005 patients in the ADA-CF and ADA-C cohorts, respectively, with most using adalimumab for rheumatoid arthritis (ADA-CF 29.7%, ADA-C 27.2%) and psoriasis (ADA-CF 24.5%, ADA-C 31.9%). Significantly greater adherence was achieved with ADA-CF compared with ADA-C (mean PDC [standard deviation] 0.68 [0.30] vs 0.61 [0.32], P < 0.0001). A significantly greater percentage of patients receiving ADA-CF (47.2%) vs ADA-C (39.6%) had PDC ≥ 80% (P < 0.0001). The discontinuation rate was significantly lower for the ADA-CF cohort (46.4%) compared with ADA-C (55.9%, P < 0.0001), resulting in a 27% lower likelihood of discontinuation during the 12-month follow-up period (hazard ratio 0.73; 95% confidence interval 0.66, 0.82; P < 0.0001) and longer time on treatment (260 vs 232 days, P < 0.0001).ConclusionAdherence and persistence are significantly improved with ADA-CF compared with ADA-C.

Background: Like other vaccines, Pfizer BioNTech's COVID-19 vaccine efficacy against SARS-CoV-2 virus infections begins to decline within a few months after the 2 (nd) dose. On August 12, 2021, the FDA allowed additional Pfizer BioNTch's COVID-19 vaccine dose (3 (rd) or booster dose) for individuals with weakened immunity. This study aimed to evaluate the short-term adverse reactions (ADRs) of the 2 (nd) and the 3 (rd) doses of the Pfizer BioNTech COVID-19 vaccine. Methods: Information for this study was collected by Google Form questionnaire (online survey). The results included responses from 442 people, the majority from Saudi Arabia. Results: The most common local ADRs following the 3 (rd) dose were injection site pain, injection site hypersensitivity, and axillary lymph node swelling. The most common systemic ADRs were fatigue, muscle pain, bone pain, headache, and fever less than 38[degrees]C. Less common systemic ADRs were shivering, fever more than 38[degrees]C, nasal congestion and rhinorrhea, arrhythmia, cough, abdominal pain, chest tightness, nausea, diarrhea, vomiting, and tachypnea. Rare systemic ADRs were constipation, dizziness and vertigo, lack of concentration, sore throat, excessive hair loss, dysmenorrhea and heavy menstruation, and Bell's palsy. Severe allergic reactions were reported by 2.6% of participants after the 2 (nd) dose, compared with none after the 3 (rd) dose. Nasal congestion and runny nose are more frequent after the 3 (rd) dose. The ADRs of the 2 (nd) and 3 (rd) doses were significantly more prevalent in females. 12% of participants reported ADRs lasting more than one week after the 3 (rd) dose compared to 5% after the 2 (nd) dose. People [less than or equal to] 60 years were more affected by the vaccine ADRs. Conclusion: Most of the ADRs reported after the 3 (rd) vaccine dose were consistent with the Pfizer vaccine information sheet and similar to the 2 (nd) dose ADRs. Keywords: Pfizer-BioNTech COVID-19 vaccine, adverse drug reactions, booster dose, second dose, injection site pain, fatigue, online questionnaire