scholarly journals Long‐term safety and efficacy of anifrolumab in adults with systemic lupus erythematosus: results of a phase 2 open‐label extension study

2020 ◽  
Author(s):  
W. Winn Chatham ◽  
Richard Furie ◽  
Amit Saxena ◽  
Philip Brohawn ◽  
Erik Schwetje ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Extension Study ◽  
Phase 2 ◽  
Systemic Lupus ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension

scholarly journals SAT0193 A PHASE 3, OPEN-LABEL, CONTINUATION STUDY EVALUATING LONG-TERM SAFETY AND EFFICACY OF BELIMUMAB IN PATIENTS FROM JAPAN AND KOREA WITH SYSTEMIC LUPUS ERYTHEMATOSUS, FOR UP TO 7 YEARS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1038.2-1039
Author(s):  
Y. Tanaka ◽  
S. C. Bae ◽  
D. Bass ◽  
M. Chu ◽  
P. Curtis ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
Open Label ◽  
Phase 3 ◽  
Safety And Efficacy ◽  
Sledai Score ◽  
Organ Domain ◽  
Domain Scores

Background:Systemic lupus erythematosus (SLE) is an autoimmune disorder more prevalent in the Asian population vs Caucasians. Belimumab (BEL), a monoclonal antibody targeting B-lymphocyte stimulator, is approved in patients (pts) ≥5 years with active, autoantibody-positive SLE.Objectives:Evaluate long-term safety and efficacy of intravenous (IV) BEL + standard SLE therapy (SST) in pts with SLE in Japan/Korea.Methods:In this Phase 3, multicentre, open-label (OL) study (BEL114333;NCT01597622), eligible (≥18 years of age) completers of the double-blind phase of GSK study BEL113750 in Japan and South Korea or the subcutaneous OL phase of GSK Study BEL112341 in Japan, received monthly BEL 10 mg/kg IV plus SST. Primary endpoints: safety assessments. Key secondary endpoints: SRI4 response rate at each scheduled visit (observed data), defined as a ≥4-point reduction from baseline in SELENA-SLEDAI score, no worsening in PGA (<0.3-point increase from baseline) and no new BILAG 1A/2B organ domain scores; time to first severe SFI flare over time. Endpoints were analysed relative to first BEL dose (parent or current study). No follow-up data were collected after study withdrawal.Results:Overall, 142 pts were enrolled (Japan n=72; Korea n=70), 104 (73.2%) completed the study, 1 (0.7%) died and 37 (26.1%) withdrew.Overall, 139 (97.9%) pts had ≥1 adverse event (AE) (Table). Most frequent AEs included: nasopharyngitis (60.6%); headache (28.2%); cough, herpes zoster and viral upper respiratory tract infection (18.3% each). Serious AEs (SAEs) occurred in 48 (33.8%) pts. Most common SAEs were infections and infestations, reported in 24 (16.9%) pts (Table). During this study, the annual incidence of AEs, including SAEs and AESI, remained stable or declined, with no trends of clinical concerns regarding the incidence of Grade 3 or 4 values for laboratory parameters. There was 1 transient positive immunogenicity result of no clinical concern.Table.The proportion of SRI4 responders was 47.8% at Year 1 (Week 24) and tended to increase numerically up to 84.6% at Year 7 (Week 48). The proportion of pts with a ≥4-point decrease from baseline in SELENA-SLEDAI score numerically increased from 51.5% at Year 1 (Week 24) to 84.6% at Year 7 (Week 48). Proportion of pts with no PGA worsening was 91.3-100% and the proportion with no new BILAG 1A/2B organ domain scores was 93.3-100% up to Year 7 (Week 48). A total of 21 (14.8%) pts had 24 severe SFI flares.Conclusion:BEL was well tolerated as add-on therapy to SST for ≤7 years in pts with SLE from Japan/Korea. Safety results were consistent with the known BEL safety profile.Study funding: GSK.Disclosure of Interests:Yoshiya Tanaka Grant/research support from: Received research grants from Asahi-Kasei, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Ono, Speakers bureau: Received speaking fees and/or honoraria from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Teijin, Sang-Cheol Bae: None declared, Damon Bass Shareholder of: GSK, Employee of: GSK, Myron Chu Shareholder of: GSK, Employee of: GSK, Paula Curtis Shareholder of: GSK, Employee of: GSK, Kathleen DeRose Shareholder of: GSK, Employee of: GSK, Beulah Ji Shareholder of: GSK, Employee of: GSK, Regina Kurrasch Shareholder of: GSK, Employee of: GSK, Jenny Lowe Shareholder of: GSK, Employee of: GSK, Paige Meizlik Shareholder of: GSK, Employee of: GSK, David Roth Shareholder of: GSK, Employee of: GSK

Efficacy and Safety of Ustekinumab in Patients with Active Systemic Lupus Erythematosus: Results Through 2 Years of an Open-Label Extension in a Phase 2 Study

2021 ◽  
pp. jrheum.210805
Author(s):  
Ronald F. van Vollenhoven ◽  
Bevra H. Hahn ◽  
George C. Tsokos ◽  
Peter Lipsky ◽  
Robert M. Gordon ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Opportunistic Infections ◽  
Active Systemic Lupus Erythematosus ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Systemic Lupus ◽  
Open Label ◽  
Phase 2 Study ◽  
Open Label Extension

Objective To evaluate long-term efficacy and safety of ustekinumab through 2 years in patients with active systemic lupus erythematosus (SLE). Methods This was a placebo-controlled (Week24) phase 2 study in 102 patients with seropositive active SLE. Patients were randomized to ustekinumab (~6 mg/kg single IV infusion, then 90 mg SC every 8 weeks) or placebo, added to background therapy. Placebo patients initiated ustekinumab (90mg SC Q8W) at Week24. Patients could enter an optional open-label study extension after Week40 (final ustekinumab administration at Week104). Efficacy assessments included SRI-4, SLEDAI-2K, PGA, and CLASI. Observed data are reported for the extension period. The final efficacy assessment was at Week112; safety was monitored through Week120. Results In this subset of patients who entered the study extension, 24 in the ustekinumab group and 14 in the placebo-crossover group completed study treatment. At Week112, 79% and 92%, respectively, had an SRI-4 response, 92% in both groups had ≥4-point improvement from baseline in SLEDAI-2K score, 79% and 93%, respectively, had ≥30% improvement from baseline in PGA, 86% and 91%, respectively, had ≥50% improvement in active joint (pain and inflammation) count, and 79% and 100%, respectively, had ≥50% improvement in CLASI activity score. No deaths, malignancies, opportunistic infections, or tuberculosis cases occurred. Safety events were consistent with the known ustekinumab safety profile. Conclusion In the 46 patients who entered the voluntary extension of this phase 2 study, clinical benefit in global and organ-specific SLE-activity measures was observed with ustekinumab through 2years with no new or unexpected safety findings. clinicaltrials.gov: NCT02349061

scholarly journals Safety and Efficacy of Filgotinib: Up to 4-Year Results From an Open-Label Extension Study of Phase 2 Rheumatoid Arthritis Programs

2021 ◽  
pp. jrheum.201183
Author(s):  
Arthur Kavanaugh ◽  
Rene R. Westhovens ◽  
Kevin L. Winthrop ◽  
Susan J. Lee ◽  
YingMeei Tan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Study Drug ◽  
Extension Study ◽  
Phase 2 ◽  
Monotherapy Group ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension ◽  
Adjusted Incidence Rate

Objective The long-term safety and efficacy of filgotinib (from phase 2 studies), with or without methotrexate (MTX), for the treatment of patients with rheumatoid arthritis was assessed in DARWIN 3, a long-term, open-label extension study (NCT02065700). Methods Eligible patients completing the 24-week DARWIN 1 (filgotinib + MTX) and DARWIN 2 (filgotinib monotherapy) studies entered DARWIN 3, where they received filgotinib 200 mg/day, except for 15 men who received filgotinib 100 mg/day. Safety analyses were performed using the safety analysis set and exposure-adjusted incidence rate (EAIR) of treatment-emergent adverse events (TEAEs) was calculated. Efficacy was assessed from baseline in the parent studies. Results Of 790 patients completing the phase 2 parent studies, 739 enrolled in the study. Through April 2019, 59.5% of patients had received ≥4 years of study drug. Mean (SD) exposure to filgotinib was 3.55 (1.57) years in the filgotinib + MTX group and 3.38 (1.59) years in the filgotinib monotherapy group. EAIR per 100 patient years of exposure (PYE) for TEAEs was 24.6 in the filgotinib + MTX group and 25.8 in the filgotinib monotherapy group, and for serious TEAEs, the EAIR was 3.1 and 4.3, respectively. ACR20/50/70 responses among patients remaining in the study could be maintained through 4 years, with 89.3%/69.6%/49.1% of filgotinib + MTX group and 91.8%/69.4%/44.4% of monotherapy group maintaining ACR20/50/70 responses based on observed data. Conclusion Filgotinib was well tolerated with a 4-year safety profile comparable to that of the parent trials, both in patients receiving combination therapy with MTX or as monotherapy.

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