Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care
| Autor: | Duncan A. Gordon, R. van Vollenhoven, M Oldham, Benjamin Wilson, David M. Roth, Murray B. Urowitz, Cynthia Aranow, C. Molta, J Fettiplace, Ian N. Bruce |
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| Přispěvatelé: | Rheumatology, AII - Inflammatory diseases |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Adult Male safety medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Gastrointestinal Diseases organ damage Population Antibodies Monoclonal Humanized Severity of Illness Index law.invention 03 medical and health sciences 0302 clinical medicine Systemic lupus erythematosus Rheumatology Randomized controlled trial Double-Blind Method law Internal medicine Severity of illness medicine Clinical endpoint Humans Lupus Erythematosus Systemic education Adverse effect 030203 arthritis & rheumatology education.field_of_study business.industry Standard of Care Middle Aged Belimumab 3. Good health Surgery Organ damage 030104 developmental biology Treatment Outcome Papers Female Every Four Weeks business Immunosuppressive Agents medicine.drug |
| Zdroj: | Bruce, I N, Urowitz, M B, van Vollenhoven, R, Aranow, C, Fettiplace, J, Oldham, M, Wilson, B, Molta, C T, Roth, D A & Gordon, D 2016, ' Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care ', Lupus, vol. 25, no. 7, pp. 699-709 . https://doi.org/10.1177/0961203315625119 Lupus, 25(7), 699-709. SAGE Publications Ltd Lupus |
| ISSN: | 0961-2033 |
| DOI: | 10.1177/0961203315625119 |
| Popis: | Objective To examine long-term organ damage and safety following treatment with belimumab plus standard of care (SoC) in patients with systemic lupus erythematosus (SLE). Methods Pooled data were examined from two ongoing open-label studies that enrolled patients who completed BLISS-52 or BLISS-76. Patients received belimumab every four weeks plus SoC. SLICC Damage Index (SDI) values were assessed every 48 weeks (study years) following belimumab initiation (baseline). The primary endpoint was change in SDI from baseline at study years 5–6. Incidences of adverse events (AEs) were reported for the entire study period. Results The modified intent-to-treat (MITT) population comprised 998 patients. At baseline, 940 (94.2%) were female, mean (SD) age was 38.7 (11.49) years, and disease duration was 6.7 (6.24) years. The mean (SD) SELENA-SLEDAI and SDI scores were 8.2 (4.18) and 0.7 (1.19), respectively; 411 (41.2%) patients had organ damage (SDI = 1: 235 (23.5%); SDI ≥ 2: 176 (17.6%)) prior to belimumab. A total of 427 (42.8%) patients withdrew overall; the most common reasons were patient request (16.8%) and AEs (8.5%). The mean (SD) change in SDI was +0.2 (0.48) at study years 5–6 ( n = 403); 343 (85.1%) patients had no change from baseline in SDI score (SDI +1: 46 (11.4%), SDI +2: 13 (3.2%), SDI +3: 1 (0.2%)). Of patients without organ damage at baseline, 211/241 (87.6%) had no change in SDI and the mean change (SD) in SDI was +0.2 (0.44). Of patients with organ damage at baseline, 132/162 (81.5%) had no change in SDI and the mean (SD) change in SDI was +0.2 (0.53). The probability of not having a worsening in SDI score was 0.88 (95% CI: 0.85, 0.91) and 0.75 (0.67, 0.81) in those without and with baseline damage, respectively (post hoc analysis). Drug-related AEs were reported for 433 (43.4%) patients; infections/infestations (282, 28.3%) and gastrointestinal disorders (139, 13.9%) were the most common. Conclusion Patients with SLE treated with long-term belimumab plus SoC had a low incidence of organ damage accrual and no unexpected AEs. High-risk patients with pre-existing organ damage also had low accrual, suggesting a favorable effect on future damage development. |
| Databáze: | OpenAIRE |
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