Search

Background In the phase 3 TULIP-2 and TULIP-1 trials in SLE, anifrolumab treatment increased the percentages of patients with BICLA responses vs placebo at Week 52 (Morand et al, 2020; Furie et al, 2019). To better understand the time course of BICLA responses to anifrolumab, we examined responses over time in TULIP-2 and TULIP-1, including sustained responses. Methods The TULIP-2 and TULIP-1 randomized, double-blind, placebo-controlled trials evaluated anifrolumab (300 mg Q4W) over 52 weeks in patients with moderately to severely active SLE receiving standard-of-care treatment. Time to onset of BICLA response sustained from attainment through Week 52 was assessed. Results At the first 3 assessments (Weeks 4, 8, and 12) in TULIP-2, numerically greater percentages of anifrolumab-treated patients (26.8%, 35.3%, and 42.9%, respectively; N=180) had a BICLA response compared with placebo (21.3%, 21.6%, and 31.8%; N=182). A similar trend was observed in TULIP-1 with anifrolumab (23.3%, 34.2%, and 36.5%; N=180) vs placebo (18.3%, 23.2%, and 27.5%; N=184). Time to onset of BICLA response in patients who achieved sustained BICLA response from onset through Week 52 in TULIP-2 (anifrolumab, n=86 [47.8%]; placebo, n=57 [31.3%]) and in TULIP-1 (anifrolumab, n=85 [47.2%]; placebo, n=55 [29.9%]) favored anifrolumab (HR=1.55, 95% CI 1.11–2.18 and HR=1.93, 95% CI 1.38–2.73, respectively; figure 1). Conclusions Anifrolumab resulted in numerically favorable differences in BICLA responses maintained through Week 52, and in time to onset thereof, across TULIP studies. These data support the sustainability of clinical benefit with anifrolumab treatment in patients with active SLE.

Background Filgotinib (FIL), an oral, selective Janus kinase 1 (JAK1) inhibitor, significantly improved the signs and symptoms of rheumatoid arthritis (RA) in the phase 3 FINCH2 study in bDMARD-IR patients with active RA.1 Objectives To evaluate the efficacy and safety of FIL by geography and race in FINCH2. Methods FINCH2 enrolled 449 bDMARD-IR patients with active RA, who were randomized in a 1:1:1 manner to receive FIL 200 mg, FIL 100 mg, or placebo (PBO) on a background of csDMARDs for 24 weeks. In this prespecified subgroup analysis, patient and disease characteristics and treatment effects were analyzed by race and geographic region (Region 1: AU, BE, FR, DE, IS, IT, NL, KR, ES, CH, UK, US; Region 2: HU, CZ, PL; Region 3: AR, PR, MX; Region 4: JP). Results 448 patients received ≥1 dose of study drug; they were 80.4% female, with a mean [SD] age of 56 [12.2] years, and 23.4% had received ≥3 prior bDMARDs). Baseline characteristics were similar across regions and race. The primary endpoint and all key secondary endpoints were met in the primary analysis.1 Efficacy and safety parameters by geography and race are shown below. There were 2 MACE (white/Region 1, 1 FIL 100/1 PBO), 4 cases of uncomplicated herpes zoster (2 black/1 white/1 Asian; 3 Region 1/1 Region 4, 2 FIL 200/2 FIL 100), and 1 VTE (retinal vein occlusion, white/Region 1/FIL 200), but no cases of DVT/PE, opportunistic infection, active tuberculosis, malignancy, gastrointestinal perforation, or death. 1n’s for HAQ-DI at week 24 were different. 2Nonresponder imputation. *p 1n’s for HAQ-DI at week 24 were different. 2Nonresponder imputation. *p Conclusion FIL demonstrated consistent safety and efficacy in bDMARD-IR patients with RA regardless of geography or race. References [1] Genovese MC, et al. ACR 2018. Abstract L06. Disclosure of Interests Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Lilly, Pfizer, Sanofi-Genzyme, UCB Pharma, Consultant for: Bristol-Myers Squibb, Eli Lilly, UCB, Sanofi-Genzyme, Pfizer, Mark C. Genovese Grant/research support from: Sanofi/Genzyme, Genentech/Roche, RPharm, Consultant for: Sanofi/Genzyme, Genentech/Roche, RPharm, Kenneth Kalunian Grant/research support from: Gilead Sciences, Inc., Neelufar Mozaffarian Shareholder of: Gilead, Employee of: Gilead, Beatrix Bartok Shareholder of: Gilead, Employee of: Gilead, Franziska Matzkies Shareholder of: Gilead, Employee of: Gilead, Jie Gao Shareholder of: Gilead, Employee of: Gilead, Ying Guo Shareholder of: Gilead, Employee of: Gilead, David Walker: None declared, Tsutomu Takeuchi Grant/research support from: Astellas Pharma Inc, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Asahikasei Pharma Corp., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Eisai Co., Ltd., AYUMI Pharmaceutical Corporation, Nipponkayaku Co. Ltd., Novartis Pharma K.K., Grant/research support from: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Grant/research support from: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Abbivie GK, Nipponkayaku Co.Ltd, Janssen Pharmaceutical K.K., Astellas Pharma Inc., Taiho Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., UCB Japan Co. Ltd., Consultant for: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., AbbVie GK, Daiichi Sankyo Co., Ltd., Bristol Myers Squibb, and Nipponkayaku Co. Ltd., Speakers bureau: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Speakers bureau: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Speakers bureau: AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Astellas Pharma Inc, Diaichi Sankyo Co. Ltd., Eisai Co. Ltd., Sanofi K.K., Teijin Pharma Ltd., Takeda Pharmaceutical Co. Ltd., Novartis Pharma K.K., Kurt de Vlam Consultant for: Pfizer Inc, Consultant for: Johnson & Johnson

Background Filgotinib (FIL), an oral selective Janus kinase 1 (JAK1) inhibitor, significantly improved the signs and symptoms of rheumatoid arthritis (RA) with a favorable safety profile in a global phase 3 study in bDMARD-IR patients with active RA (FINCH2).1 Objectives To assess the safety and efficacy of FIL in the FINCH2 study by the number and type of prior bDMARDs. Methods FINCH2 enrolled 449 bDMARD-IR patients with moderate-to-severe active RA. Patients were randomized 1:1:1 to FIL 200 mg, FIL 100 mg or placebo (PBO) on a background of csDMARDs for 24 weeks. In this prespecified subgroup analysis, efficacy and safety were analyzed according to the number ( Results 448 patients received ≥1 dose of study drugs. Of these, 343 were previously exposed to Conclusion In bDMARD-IR patients with active RA, FIL treatment for 24 weeks significantly improved the signs and symptoms of RA with a favorable safety profile; notably, efficacy and safety results were similar for patients with Reference [1] Genovese MC, et al. ACR 2018. Abstract L06. Disclosure of Interests Mark C. Genovese Grant/research support from: Sanofi/Genzyme, Genentech/Roche, RPharm, Consultant for: Sanofi/Genzyme, Genentech/Roche, RPharm, Kenneth Kalunian Grant/research support from: Gilead Sciences, Inc., Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Lilly, Pfizer, Sanofi-Genzyme, UCB Pharma, Consultant for: Bristol-Myers Squibb, Eli Lilly, UCB, Sanofi-Genzyme, Pfizer, Neelufar Mozaffarian Shareholder of: Gilead, Employee of: Gilead, Beatrix Bartok Shareholder of: Gilead, Employee of: Gilead, Franziska Matzkies Shareholder of: Gilead, Employee of: Gilead, Jie Gao Shareholder of: Gilead, Employee of: Gilead, Ying Guo Shareholder of: Gilead, Employee of: Gilead, Kurt de Vlam Consultant for: Pfizer Inc, Consultant for: Johnson & Johnson, David Walker: None declared, Tsutomu Takeuchi Grant/research support from: Astellas Pharma Inc, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Asahikasei Pharma Corp., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Eisai Co., Ltd., AYUMI Pharmaceutical Corporation, Nipponkayaku Co. Ltd., Novartis Pharma K.K., Grant/research support from: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Grant/research support from: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Abbivie GK, Nipponkayaku Co.Ltd, Janssen Pharmaceutical K.K., Astellas Pharma Inc., Taiho Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., UCB Japan Co. Ltd., Consultant for: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., AbbVie GK, Daiichi Sankyo Co., Ltd., Bristol Myers Squibb, and Nipponkayaku Co. Ltd., Speakers bureau: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Speakers bureau: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Speakers bureau: AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Astellas Pharma Inc, Diaichi Sankyo Co. Ltd., Eisai Co. Ltd., Sanofi K.K., Teijin Pharma Ltd., Takeda Pharmaceutical Co. Ltd., Novartis Pharma K.K.

Background Filgotinib (FIL), an oral selective Janus kinase 1 (JAK1) inhibitor, demonstrated efficacy and safety vs placebo (PBO) in bDMARD-IR patients with active RA in a global phase 3 study (FINCH2, ClinicalTrials.gov NCT02873936).1 Objectives We performed a prespecified subgroup analysis of the safety and efficacy of FIL in patients aged ≥65 years vs Methods 449 patients were randomized 1:1:1 to FIL 200 mg, FIL 100 mg, or PBO on a background of csDMARDs for 24 weeks. The primary efficacy endpoint was ACR20 response at week 12. Results Of 448 patients who received ≥1 dose of study drugs, 113 (25.2%) were ≥65 years of age; baseline disease characteristics were similar for both age groups. Safety and efficacy parameters by age group are in Tables 1 and 2. The most common treatment-emergent adverse events (TEAEs, by System Organ Class) category was infections and infestations; nasopharyngitis, upper respiratory tract infections, and bronchitis were the most common infections and infestations in the FIL arms in both age groups. There were no cases of opportunistic infection, active tuberculosis, malignancy, gastrointestinal perforation, or death. Efficacy outcomes were similar for both groups. Conclusion Overall, older age was not associated with higher incidence of safety events (serious infections, herpes zoster, MACE occurred in the group Reference [1] MC Genovese, et al. ACR, 2018. Abstract L06. Disclosure of Interests Kenneth Kalunian Grant/research support from: Gilead Sciences, Inc., Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Lilly, Pfizer, Sanofi-Genzyme, UCB Pharma, Consultant for: Bristol-Myers Squibb, Eli Lilly, UCB, Sanofi-Genzyme, Pfizer, Mark C. Genovese Grant/research support from: Sanofi/Genzyme, Genentech/Roche, RPharm, Consultant for: Sanofi/Genzyme, Genentech/Roche, RPharm, Neelufar Mozaffarian Shareholder of: Gilead, Employee of: Gilead, Beatrix Bartok Shareholder of: Gilead, Employee of: Gilead, Franziska Matzkies Shareholder of: Gilead, Employee of: Gilead, Jie Gao Shareholder of: Gilead, Employee of: Gilead, Ying Guo Shareholder of: Gilead, Employee of: Gilead, Tsutomu Takeuchi Grant/research support from: Astellas Pharma Inc, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd., AbbVie GK, Asahikasei Pharma Corp., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Eisai Co., Ltd., AYUMI Pharmaceutical Corporation, Nipponkayaku Co. Ltd., Novartis Pharma K.K., Grant/research support from: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Grant/research support from: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Abbivie GK, Nipponkayaku Co.Ltd, Janssen Pharmaceutical K.K., Astellas Pharma Inc., Taiho Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., UCB Japan Co. Ltd., Consultant for: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Consultant for: Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., AbbVie GK, Daiichi Sankyo Co., Ltd., Bristol Myers Squibb, and Nipponkayaku Co. Ltd., Speakers bureau: Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., Janssen Pharmaceutical K.K., Celltrion Inc., Nipponkayaku Co. Ltd., and UCB Japan, Speakers bureau: AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, Teijin, Speakers bureau: AbbVie GK., Bristol–Myers K.K., Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Astellas Pharma Inc, Diaichi Sankyo Co. Ltd., Eisai Co. Ltd., Sanofi K.K., Teijin Pharma Ltd., Takeda Pharmaceutical Co. Ltd., Novartis Pharma K.K., Kurt de Vlam Consultant for: Pfizer Inc, Consultant for: Johnson & Johnson, David Walker: None declared

Background Targeted, biologic inhibitors of B-cell Activating Factor (BAFF) have been evaluated in Phase 3 trials in over 5000 patients with SLE. Post hoc analyses of these studies identify lower placebo response and greater treatment effect using more stringent endpoints in patients entering with higher disease activity, greater corticosteroid doses, and/or anti-double-stranded DNA (dsDNA) and low complement C3 or C41,2. Objectives The Phase 3 CHABLIS-SC1 trial evaluated blisibimod, an inhibitor of B-cell activating factor (BAFF), in a “responder population” identified from prior studies with this drug class. Methods 442 SLE patients with anti-nuclear antibodies or anti-dsDNA, SELENA-SLEDAI score ≥10 on standard of care medications were randomized to receive weekly subcutaneous blisibimod (200 mg) or placebo. Corticosteroid taper was encouraged from Week 8 with the goal to reach ≤7.5 mg prednisone/day. The primary endpoint at Week 52 was the SLE Responder Index-6 (SRI-6): ≥6-point improvement in SELENA-SLEDAI, no new BILAG 1A or 2B domain scores, and Results This study did not meet its primary endpoint at Week 52. Response rates to blisibimod were equivalent to past trials of BAFF inhibitors, but the placebo response was greater. A slightly higher proportion of subjects on blisibimod met the SRI-6 and SRI-4 criteria at most timepoints and more blisibimod-treated subjects achieved corticosteroid taper to prednisone ≤7.5 mg/day from Week 40 through Week 52 (p=0.04 at Week 44). Reductions in peripheral B cell lineages, anti-dsDNA, anti-phospholipid antibodies, and serum immunoglobulins, and increases in complement C3 and C4 were observed with blisibimod (see Table). Blisibimod was well-tolerated. The most common adverse events were upper respiratory tract infection (10.6% vs 14.3% on placebo), urinary tract infection (6.9% vs 10.7%), injection site erythema (7.8% vs 2.0%), injection site reaction (7.3% vs 2.6%), and diarrhea (7.3% vs 2.6%). Conclusions With a deliberate focus on a “responder population” for whom lower placebo rates were observed in previous trials, much higher placebo response rates were observed in the CHABLIS-SC1 trial. Modest benefits of blisibimod were observed on serological effects and corticosteroid tapering. References van Vollenhoven RF et al. Ann Rheum Dis. 2012;71:1343. Merrill JT et al. Ann Rheum Dis. 2016;75(2):332–40. Disclosure of Interest J. Merrill Grant/research support from: BMS, GSK, Consultant for: Anthera, GSK, EMD Serono, Lilly, Astra Zeneca, BMS, UCB, Celgene, Biogen, R. Martin Shareholder of: Anthera, Employee of: Anthera, W. Shanahan Shareholder of: Anthera, Employee of: Anthera, M. Scheinberg Consultant for: GSK,Pfizer, Janssen, Genzyme,Anthera, Novartis, Speakers bureau: GSK,Pfizer, Janssen, Genzyme,Anthera, Novartis, K. Kalunian Grant/research support from: GSK, Celgene, UCB, Consultant for: Anthera, Genentech, BMS, Lilly, Biogen, Shire, Exagen, D. Wofsy Consultant for: Anthera, Genentech, Amgen, GSK