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Experimental studies have showed that hepatocellular carcinoma (HCC) cells are susceptible to cytolysis of interleukin (IL)-2-activated lymphocytes. Moreover, our previous studies demonstrated that the pineal neurohormone melatonin (MLT) may enhance IL-2 efficacy. On this basis, a study was started with low-dose IL-2 (3 million U/day subcutaneously for 6 days/week for 4 weeks) plus MLT (50 mg/day orally every day given in the evening) as a first-line therapy of unresectable HCC. The study included 14 patients. Objective tumour regressions were obtained in 5/14 (36%) patients (one complete response, four partial responses), with a median duration of 7+ months. 6 patients had stable disease, while the other 3 progressed. Toxicity was low in all cases. This study shows that the neuroimmunotherapy with low-dose IL-2 plus MLT is a new well-tolerated and effective therapy of advanced HCC.

Background and Objectives: Subcutaneous immunoglobulin (SCIG) therapy is becoming increasingly popular as self-administration is possible because intravenous access is unnecessary, and there is a lower frequency of systemic adverse events. The aim of this study was to evaluate the shifting from intravenous immunoglobulins (IVIGs) replacement therapy to SCIG in patients with primary immunodeficiency (PID) in a routine real-life situation.Methods: In a multicenter prospective observational study, we enrolled 50 patients suffering from PID who were monitored for 24 months; 44 patients switched from IVIG and six from different SCIG preparations. The study preparation (human IgG 16 %, Vivaglobin®, CSL Behring GmbH, Germany) was subcutaneously infused weekly (maximum volume 15 mL/site; maximum infusion rate 22 mL/h). The study endpoints were: annual rate of severe bacterial infections (SBIs), local adverse reactions, quality of life, days off school/work, and days of hospitalization.Results: Thirty-three of 39 (84.6 %) patients who completed the study experienced an infection or signs thereof. Only five SBIs were observed, corresponding to an annual rate of 0.056 episodes per patient in 44 subjects [intention-to-treat (ITT) population]. A significant decrease in both days of hospitalization (1.93 ± 4.08 vs. 0.64 ± 2.94) and days off school/work (15.27 ± 23.17 vs. 2.26 ± 4.45) was recorded at 24 months. Local reactions were observed in 14/50 (28 %) patients, mainly consisting of skin manifestations at the injection site. Only three (6.8 %) patients discontinued due to infusion site reactions. In patients shifting from IVIG to SCIG, the total mean score of Life Quality Index (LQI) improved from 76.9 ± 16.8 to 90.7 ± 11.6 (P < 0.01) at 6 months; there was an improvement also in the overall patients’ evaluation.Conclusions: A total of 93.2 % patients tolerated the new route of administration and reported a significant improvement in their LQI. Our results from a routine clinical practice in a real-life population are consistent with those of phase III clinical studies.

In the present single-center retrospective study, we investigated our data to evaluate the efficacy of the classic antibiotic combination (rifampicin and clindamycin) compared to adalimumab treatment in patients affected by moderate-to-severe hidradenitis suppurativa. Disease severity and quality of life were registered using the modified Sartorious score and Hidradisk, respectively. Data were collected before starting treatment (T0) and after ten weeks of therapy (T10). The Mann-Whitney test was used to calculate statistical differences between baseline and week 10. P values less than 0.05 were considered to be statistically significant. A spearman test was used to evaluate the correlation among the parameters under study. Thirty patients (20 females, 10 males; mean age, 23.73 ± 4.57) were given the antibiotics: instead of starting the treatment by combining the two antibiotics, we recommend patients to start the therapy taking only rifampicin 300 mg twice a day for 7 days, and after the first week, to add clindamycin at a dose of 300 mg twice a day. The mean modified Sartorius Score before starting treatment was 68.8 while the value at week 10 was 57.8 (P equals 0.0052). The mean Hidradisk value before starting treatment was 74,73 while the value at week 10 was 62 (P equals 0.0095). Ten patients (10/30) achieved the HiSCR. On the other hand, thirty subjects (22 females, 8 males; mean age, 26.2±7.25) were treated with subcutaneous injections of adalimumab (160 mg at baseline, 80 mg at week 2, 40 mg at week 4, and 40 mg weekly thereafter). The mean modified Sartorius Score before starting treatment was 74.93 while the value at week 10 was 39.86 (P less than 0.0001). The mean Hidradisk value before starting treatment was 77.73 while the value at week 10 decreased to 51.86 (P less than 0.0001). Eighteen patients (18/30) achieved the HiSCR. J Drugs Dermatol. 2019;18(5):437-438.