Real-World Effectiveness of Intravenous Belimumab on Clinical Outcomes in Patients With Systemic Lupus Erythematosus in Saudi Arabia: The OBSErve Observational Study

Ibrahim Abdulrazag Al-Homood,1 Ibrahim Almaghlouth,2 Alhussain Mohammed Asiri,3 Hanan Hamdy,4 Ali Alhammad,5 Alaa Mustafa,6 Mohamed Othman,6 Munther Khamashta,7 Tamer Elfishawy,7 Lindsey Teichman,8 Debora dos Santos,9 Juliana Domenico Queiroz,9 Saeed Noibi5 1Department of Medicine, King Fahad Medical City, Riyadh, Saudi Arabia; 2Rheumatology Unit, Department of Medicine, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia; 3Medical Department, Asir Central Hospital, Abha, Aser, Saudi Arabia; 4Internal Medicine, King Fahad Specialist Hospital, Tabouk, Saudi Arabia; 5Value Evidence and Outcomes, GSK Saudi Arabia, Jeddah, Saudi Arabia; 6Medical Affairs, GSK Saudi Arabia, Jeddah, Saudi Arabia; 7Medical Affairs, GSK, Dubai, United Arab Emirates; 8Real World Matrix Team, GSK, Dubai, United Arab Emirates; 9Real World Matrix Team, GSK, Rio de Janeiro, BrazilCorrespondence: Ibrahim Abdulrazag Al-Homood, King Fahad Medical City, 6496 Makkah Al Mukarrama Road, Riyadh, 12231, Saudi Arabia, Tel +9662889999, Email [email protected]: To describe intravenous (IV) belimumab’s clinical effectiveness in patients with systemic lupus erythematosus (SLE) in real-world practice in Saudi Arabia.Patients and methods: This retrospective, observational OBSErve study (GSK Study 215349) analyzed medical record data for adults with SLE receiving IV belimumab. Index date was the date of belimumab initiation. The primary endpoint was overall clinical response per physician judgement (categorized as worse, no improvement, improvement of < 20%, 20– 49%, 50– 79%, ≥ 80%) at 6 months post-index. The secondary endpoints included changes from index in Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score and corticosteroid dose at 6 months post-index; and healthcare resource utilization (HCRU) 6 months pre- and post-index.Results: Of 47 patients enrolled, 44 patients completed ≥ 6 months of IV belimumab treatment and were included in the analysis. Most patients were female (91.5%) and the mean (standard deviation [SD]) age was 33.1 (8.1) years. At 6 months post-index, overall physician-assessed clinical improvements of ≥ 20% and ≥ 50% were reported for 97.7% (n=43) and 79.5% (n=35) of patients, respectively; 2.3% (n=1) of patients had no improvement, and no patient worsened. Mean SELENA-SLEDAI score decreased by 7.8 points during the 6 months post-index. Mean (SD) corticosteroid dose decreased from 10.2 (7.5) mg/day at index to 6.2 (3.4) mg/day at 6 months post-index. Reductions in unscheduled physician office and emergency room visits were observed during the post-index versus pre-index periods.Conclusion: Real-world data from patients with SLE treated with IV belimumab in Saudi Arabia demonstrated clinical improvements and reductions in corticosteroid dose and HCRU. Although the low number of patients and lack of a control group limit interpretation, the similar findings to the other OBSErve studies support the effectiveness of belimumab for patients with SLE in Saudi Arabia.Keywords: disease activity, disease modification, glucocorticoids, monoclonal antibody, systemic lupus erythematosu

An exploratory study of Muslim adolescents' views on sexuality: Implications for sex education and prevention

<p>Abstract</p> <p>Background</p> <p>This paper describes the results of an exploratory qualitative study on Muslim adolescents' views on sexuality in the Netherlands.</p> <p>Methods</p> <p>Data were gathered from an Internet forum on which 44 Muslim and 33 non-Muslim adolescents discussed sexuality as it relates to Islam. These discussions were subsequently analyzed for content using Nvivo 2.0.</p> <p>Results</p> <p>Our analysis revealed several issues that are relevant for the design of future sex education programs targeting Muslim youth. Apart from some expected outcomes regarding, for example, taboos on sexuality, sex outside marriage, abortion, homosexuality and conservative gender roles, our analyses showed that in cases of disputes 1) discussions were polarized, 2) opponents used the same Qur'anic passages to support their views, and 3) the authority of an Imam was questioned when his interpretation of Qur'anic passages was not in line with the views of participants.</p> <p>Conclusions</p> <p>Our findings show that current approaches to sex education among Muslim youth are likely to be unsuccessful given the rigidity of sexual norms in Muslim society. In addition, we also identified new barriers to sex education among Muslim youth (e.g. lack of respect for an Imam who opposes a youth's views on sexuality).</p

Real-world effectiveness of intravenous belimumab in adults with systemic lupus erythematosus: results of the observational OBSErve study in the Russian Federation

Abstract Background The real-world effectiveness of intravenous (IV) belimumab in treating systemic lupus erythematosus (SLE) has been demonstrated in various countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) program. Here we describe the clinical effectiveness of IV belimumab for treating SLE in real-world clinical practice in the Russian Federation. Methods In the retrospective, observational OBSErve Russia study (GSK Study 215349), eligible physicians enrolled adults with SLE receiving IV belimumab as part of their standard care. De-identified data were collected from patient medical records from September 2021 to March 2022. The primary outcome was the physician-assessed overall clinical response at 6 months post-index versus index (belimumab initiation) among patients receiving belimumab for ≥6 months. Other endpoints included change in Safety of Estrogens in Lupus Erythematosus National Assessment – SLE Disease Activity Index (SELENA-SLEDAI) score and glucocorticoid use. Results Overall, 59 patients initiated IV belimumab, mainly due to the previous regimen not being effective and to decrease glucocorticoid use (76.3% each); 15.3% of patients started belimumab within the first year of SLE diagnosis. Only 13.6% of patients discontinued belimumab within the first 6 months, mainly due to loss to follow-up and loss of insurance/reimbursement. At 6 months post-index, among patients who completed ≥6 months of belimumab therapy (full analysis set, n = 53), 90.6% and 60.4% had an overall clinical improvement of ≥20% and ≥50%, respectively. Mean (standard deviation, SD) change in SELENA-SLEDAI score from index to 6 months post-index was −5.9 (4.3). Mean (SD) glucocorticoid dose decreased from 12.2 (7.3) mg/day at index to 8.6 (5.1) mg/day at 6 months post-index (n = 50). Conclusions Patients with SLE receiving IV belimumab for 6 months in real-world settings in the Russian Federation experienced overall clinical improvements and reductions in glucocorticoid use, which is an important long-term strategy of SLE treatment