Impact of Parallel Topical Treatment with Nadifloxacin and Adapalene on Acne Vulgaris Severity and Quality of Life: A Prospective, Uncontrolled, Multicentric, Noninterventional Study

<b><i>Introduction:</i></b> Daily parallel application of adapalene and nadifloxacin has been determined to be effective and well tolerated in patients with acne vulgaris in randomized, controlled clinical studies. Here, the authors report the results from a large, prospective, uncontrolled, multicentric, noninterventional study under real-life conditions in Germany. The effect of treatment on acne severity, safety, and, for the first time, health-related quality of life (HRQoL) was investigated. <b><i>Methods:</i></b> Of the 292 patients (safety collective: 231 adults, 61 adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 adolescents) were treated with adapalene 0.1% cream or gel and nadifloxacin 1% cream for the defined minimum of 28 days. Patients were evaluated for acne severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and safety. <b><i>Results:</i></b> After the median treatment duration of 37 and 38 days (adults and adolescents, respectively), 93.4% and 85.0% of adults and adolescents, respectively, exhibited a sustained decrease in acne severity. The LRAG decreased by at least 3 scores in 29.1% and 24.6% of female and male adults, respectively. HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children’s Dermatology Life Quality Index). Female adults were more impaired in terms of HRQoL compared to male adults. The 2 best overall efficacy ratings were provided by physicians in 79.3% and 69.5% and by patients in 68.5% and 58.3% of adult and adolescent cases, respectively. The treatment was well tolerated, as reflected in the low number of 9 mild adverse events (AEs), all of which resolved without treatment. However, 4 patients terminated the study prematurely due to AEs. <b><i>Conclusion:</i></b> In this study, the parallel use of adapalene and nadifloxacin for at least 5 weeks resulted in a rapid improvement in acne severity, an increase in HRQoL, and a good safety profile. Therefore, it represents a promising treatment option that offers the possibility of flexible therapy adjustment.

Real-World Rates of Bleeding, Factor VIII Use, and Quality of Life in Individuals with Severe Haemophilia A Receiving Prophylaxis in a Prospective, Noninterventional Study

Regular prophylaxis with exogenous factor VIII (FVIII) is recommended for individuals with severe haemophilia A (HA), but standardised data are scarce. Here, we report real-world data from a global cohort. Participants were men ≥18 years old with severe HA (FVIII ≤ 1 IU/dL) receiving regular prophylaxis with FVIII. Participants provided 6 months of retrospective data and were prospectively followed for up to 12 months. Annualised bleeding rate (ABR) and FVIII utilisation and infusion rates were calculated. Differences between geographic regions were explored. Of 294 enrolled participants, 225 (76.5%) completed ≥6 months of prospective follow-up. Pre-baseline and on-study, the median (range) ABR values for treated bleeds were 2.00 (0–86.0) and 1.85 (0–37.8), respectively; the median (range) annualised FVIII utilisation rates were 3629.0 (1008.5–13541.7) and 3708.0 (1311.0–14633.4) IU/kg/year, respectively; and the median (range) annualised FVIII infusion rates were 120.0 (52.0–364.0) and 122.4 (38.0–363.8) infusions/year, respectively. The median (range) Haemo-QoL-A Total Score was 76.3 (9.4–100.0) (n = 289), ranging from 85.1 in Australia to 67.7 in South America. Physical Functioning was the most impacted Haemo-QoL-A domain in 4/6 geographic regions. Despite differences among sites, participants reported bleeding requiring treatment and impaired physical functioning. These real-world data illustrate shortcomings associated with FVIII prophylaxis for this global cohort of individuals with severe HA.

Patient-Reported Outcomes in RA Patients Treated With Tofacitinib or bDMARDs in Real-life Conditions in Two Latin American Countries

Objective: To describe the efficacy, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions.Methods: A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Demographic and clinical information was collected. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LMDs).Results: Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients’ mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01) and the mean DAS28-ESR was 5.48 (SD 2.97). The change from baseline at month 6 was not statistically significant different in the adjusted LMD [SE] for tofacitinib vs. bDMARDs for RAPID3 score (-0.20 [0.69] vs. -0.32 [0.71]), HAQ-DI score (-0.56 [0.07] vs. -0.50 [0.08]), EQ-5D-3L score (0.23 [0.06] vs. 0.29 [0.06]) and DAS28-ESR (-3.86 [0.59] vs. -4.23 [0.61]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported. These results have noninterventional-study-specific limitations.Conclusion: Changes from baseline were not statistically significant different between tofacitinib and bDMARDs in terms of RAPID3 scores and the secondary outcomes (HAQ-DI score, EQ-5D-3L score and DAS28-ESR). Patients from both groups presented similar proportions of nonserious and serious AEs.Clinical trial number: NCT03073109