Safety Of Filgotinib In Patients Research Articles

Efficacy and safety of filgotinib in patients with rheumatoid arthritis: week 156 interim results from a long-term extension study

BackgroundJanus kinase inhibitors are an effective option for achieving sustained remission or low disease activity in patients with rheumatoid arthritis (RA) following inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs....

Efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and an inadequate response to methotrexate.

Clinical trials restricted to moderately active RA are limited. Filgotinib is approved for treating moderate to severe active RA. This post hoc analysis assessed efficacy and safety of filgotinib in moderately active RA. In FINCH 1, patients with active moderate to severe RA and inadequate response to methotrexate received filgotinib 200 mg or 100 mg (FIL200/FIL100) once daily, adalimumab 40 mg every 2 weeks, or placebo, all with methotrexate (n = 1,755). This subgroup analysis was conducted in patients with a moderate baseline Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP; >3.2 to ≤ 5.1; n = 425 [24.2%]). A higher proportion of patients achieved DAS28-CRP <2.6, Clinical Disease Activity Index (CDAI) remission (≤2.8), low disease activity (LDA) (DAS28-CRP ≤3.2 or CDAI ≤10), and American College of Rheumatology (ACR20/50/70) responses with FIL200 and FIL100 vs placebo at Weeks 12 and 24. Week 12 ACR20 response rates (primary end point) were 77.9%, 67.8%, and 43.8%, respectively. ∼75% of patients achieved DAS28-CRP LDA by week 24 with either filgotinib dose. FIL200 and FIL100 elicited greater improvements in patient-reported outcomes than placebo. The efficacy of filgotinib, maintained through week 52, was comparable to that of adalimumab. Frequency of adverse events (AEs) was similar with filgotinib and adalimumab. Infections were the most common AEs; incidence rates were 40-53% in active treatment groups. In this subpopulation with moderately active RA, the efficacy and safety of filgotinib were similar to those in the overall FINCH 1 population (patients with active moderate to severe RA). NCT02889796.

Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study.

SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis. Data from the phase 2b/3 SELECTION study were used for this post hoc analysis. Patients were randomised [2:2:1] to two induction studies [biologic-naive, biologic-experienced] to filgotinib 200 mg, 100 mg, or placebo. At Week 10, patients receiving filgotinib were re-randomised [2:1] to continue filgotinib or to switch to placebo until Week 58 [maintenance]. Outcomes were compared between subgroups with and without concomitant IM use. At Week 10, similar proportions of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved Mayo Clinic Score [MCS] response [biologic-naive: 65.8% vs 66.9%; biologic-experienced: 61.3% vs 50.5%] and clinical remission [biologic-naive: 26.0% vs 26.2%; biologic-experienced: 11.3% vs 11.5%]. At Week 58, similar proportion of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved MCS response [biologic-naive: 74.2% vs 75.0%; biologic-experienced: 45.5% vs 61.4%] and clinical remission [biologic-naive: 51.6% vs 47.4%; biologic-experienced: 22.7% vs 24.3%]. The probability of protocol-specified disease worsening during the maintenance study in patients treated with filgotinib 200 mg did not differ between +IM and -IM groups [p = 0.6700]. No differences were observed in the incidences of adverse events between +IM and -IM groups in the induction/maintenance studies. The efficacy and safety profiles of filgotinib treatment in SELECTION did not differ with or without concomitant IM use. NCT02914522.

Filgotinib in rheumatoid arthritis

Introduction Rheumatoid Arthritis (RA) remains a challenge for rheumatologists and patients despite implementation of intensive treat-to-target strategies in shared decision with patients and an increasing availability of drugs. Janus kinase inhibitors (JAKi) are a new generation of oral targeted drugs. Filgotinib preferentially inhibits JAK1 and is the latest JAKi to be approved for use in RA. Areas covered This narrative review focuses on drug characteristics, efficacy and safety of filgotinib in patients with RA, summarizing available literature. Trial data are detailed, put into perspective for practice and discussed in regulatory perspective. Expert opinion Preclinical studies demonstrate preferential inhibition of JAK1 and a promising pharmacokinetic profile with few drug-drug interactions. Increase in hemoglobin in line with preferential inhibition of JAK1 over JAK2 is seen in early phase clinical trials. A phase III program demonstrates efficacy in several disease stages, numerically higher with 200mg versus 100mg daily. In the overall RA population such dose related effect is not observed for safety except for herpes zoster and increases in lipids and creatine phosphokinase. This reassuring safety profile is to be confirmed in future practice. It also needs to be unraveled if JAK1 preferential inhibition plays a key role in this safety profile.

Correction: Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study

Correction: Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study

Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study.

This exploratory analysis of FINCH 1 (NCT02889796) examined filgotinib (FIL) efficacy and safety in a subgroup of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX; MTX-IR) who had four poor prognostic factors (PPFs). Patients with MTX-IR received placebo up to week (W)24 or FIL200mg, FIL100mg, or adalimumab up to W52; all received MTX. Efficacy and safety data were stratified by four PPFs versus fewer than four PPFs: seropositivity, high-sensitivity C-reactive protein (CRP) ≥ 6mg/L, Disease Activity Score in 28 joints with CRP > 5.1, and erosions on X-rays. At baseline, 687/1755 patients had four PPFs. At W12, whether with four PPFs or fewer than four PPFs, response rates on all American College of Rheumatology (ACR) measures were significantly greater with FIL200 and FIL100 versus placebo. At W52, FIL200 ACR20/50/70 response rates remained at least numerically higher versus adalimumab in both subgroups. At W52, FIL200 reduced modified total Sharp score (mTSS) change versus adalimumab in patients with four or fewer than four PPFs. In high-risk (four PPFs) patients with MTX-IR RA, FIL200 and FIL100 showed similar reductions in disease activity versus placebo at W12 as in patients with fewer than four PPFs. mTSS in patients receiving FIL200 changed little from W24 to W52, while that in patients receiving FIL100 progressed comparably to patients who received adalimumab. Tolerability was comparable across treatment arms and subgroups.

Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis.

Global clinical trials in rheumatoid arthritis (RA) often do not recruit enough patients from diverse racial and ethnic backgrounds to identify any potential differences in treatment outcome across such groups. To overcome this limitation, using data from five previous clinical trials and two ongoing trial extensions, this study aimed to assess the efficacy and safety of filgotinib in patients with RA across geographic regions. This was a post hoc, exploratory analysis of data from male and female patients with RA meeting the 2010 RA criteria as defined by the American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology. Data were analyzed from phase 2 (DARWIN 1-2) and phase 3 (FINCH 1-3) clinical trials, as well as two long-term extension studies (DARWIN 3, FINCH 4), of filgotinib. Efficacy endpoints included ACR 20%/50%/70% improvement (ACR20/50/70) responses, disease activity score in 28 joints using C-reactive protein [DAS28(CRP)], Clinical Disease Activity Index scores, Boolean remission, and change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI).Safety data were presented as exposure-adjusted incidence rates per 100 patient-years of exposure of treatment-emergent adverse events. Compared with placebo, at week 12 a greater proportion of patients receiving filgotinib 200mg (FIL200) or 100mg (FIL100) achieved ACR20 (p < 0.01), with similar outcomes in most regions. Overall, the reduction in HAQ-DIwith FIL200 or FIL100was greater thanwith placebo (p < 0.05) at week 12. Compared with placebo, at week 24 the proportions of patients achieving DAS28(CRP) ≤ 3.2 were greater for both doses of FIL, as seen in most regions (p < 0.01). Safety outcomes did not indicate regional or ethnic differences in the safety profile of filgotinib. Filgotinib efficacy and safety in patients with RA were generally consistent across geographic regions. NCT02889796; NCT02873936; NCT02886728; NCT03025308; NCT01888874; NCT01894516; NCT02065700.

Filgotinib for moderately to severely active ulcerative colitis

ABSTRACT Introduction Filgotinib is an oral Janus kinase type 1 (JAK1) selective inhibitor with demonstrated efficacy and safety in ulcerative colitis (UC). The aim of this review is to summarize the available evidence on pharmacological characteristics, efficacy, and safety of filgotinib in UC. Areas covered Pubmed, Scopus, and Embase databases were searched for all relevant studies reporting the efficacy and safety of filgotinib in patients with moderate to severe UC. We particularly focused on the risk of zoster infection and venous thromboembolism compared to other JAK inhibitors. Expert opinion Filgotinib has remarkable efficacy, safety, and tolerability profiles in the treatment of moderate-to-severe active UC. It can be used in both biologic-naïve and biologic-experienced patients. The rapid mechanism of action and its oral administration route make it a reliable therapeutic option.

OA29 Clinical outcomes up to week 48 of filgotinib treatment in an ongoing long-term extension trial of RA patients with inadequate response to methotrexate initially treated with filgotinib or adalimumab during the Phase 3 Parent Trial

Abstract Background/Aims The preferential Janus kinase (JAK)-1 inhibitor filgotinib (FIL) is approved for treatment of moderately to severely active RA in Europe and Japan. We assessed efficacy and safety of FIL in patients (pts) with inadequate response to MTX (MTX-IR) who completed a Phase 3 trial (NCT02889796) and went on to enroll in a long-term extension (LTE; NCT03025308). Methods Pts who completed the parent study (PS) on study drug were eligible to enter the LTE. LTE data cutoff was June 1, 2020, and safety data are reported to that date, with median exposure 2.2 years. Efficacy data to W48 are reported for 4 treatment groups (all with background MTX): pts who received FIL 200mg (FIL200) or FIL 100mg (FIL100) in the PS and continued their dose in LTE (FIL200/FIL200, FIL100/FIL100) and ADA pts who were re-randomized, double blind, to FIL200 or FIL100 for LTE (ADA/FIL200, ADA/FIL100). ACR20/50/70 response rates, DAS28[CRP] ≤3.2 and &amp;lt;2.6, and CDAI ≤10 and ≤2.8 are reported. Exposure-adjusted incidence rates (EAIR)/100 pt-years of exposure of treatment-emergent adverse events (TEAEs) and AEs of special interest (AESIs) are summarized. Results As of June 1, 2020, 522/571 (91%) FIL200/FIL200, 502/570 (88%) FIL100/FIL100, 118/128 (92%) ADA/FIL200, and 115/130 (89%) ADA/FIL100 pts were still on study drug. LTE baseline (BL) disease characteristics were similar between groups: mean duration of RA was approximately 8.7 years; DAS28(CRP) was 2.55 and mean MTX dosage was 15.0 mg/week. Proportions of pts achieving ACR20/50/70, DAS28(CRP) ≤3.2, &amp;lt;2.6, and CDAI ≤10, ≤2.8 were maintained in all 4 LTE groups through W48. Numerically greater proportions of pts met response criteria at W48 in the FIL200 groups vs FIL100, regardless of PS treatment. TEAEs, serious AEs, and AEs Grade ≥3 were largely comparable between groups and lowest in ADA/FIL100 pts. There were 3 deaths in each PS FIL group and 2 in each PS ADA group; EAIRs for deaths were lower for FIL/FIL groups compared with ADA/FIL groups. Opportunistic infections occurred only in FIL/FIL pts (2 in each group). Nonmelanoma skin cancer (NMSC; n = 5) occurred only in FIL/FIL groups, and malignancies excluding NMSC occurred in all groups except ADA/FIL100. Conclusion During the LTE through W48, response rates were maintained for FIL/FIL and ADA/FIL pts. Though there were differences between LTE groups, safety was largely comparable and consistent with that observed in the PS and in previously reported results of safety data from 7 trials: rates of AESIs were low, and all confidence intervals were overlapping. Limitation: the LTE was not formally randomized for comparison between FIL/FIL and ADA/FIL treatment groups, the groups were of unequal size, and the switch from ADA to FIL for LTE was by design, rather than based on disease activity. Disclosure B. Combe: Consultancies; AbbVie; Eli Lilly &amp; Co.; Gilead Sciences, Inc.; Janssen; Pfizer; Roche-Chugai; and Sanofi. Member of speakers’ bureau; for BMS; Eli Lilly &amp; Co.; Gilead Sciences, Inc.; MSD; Pfizer; Roche- Chugai; and UCB. Grants/research support; Novartis, Pfizer, and Roche-Chugai. Y. Tanaka: Consultancies; Eli Lilly, Daiichi- Sankyo, Taisho, Ayumi, Sanofi, GSK, Abbvie. Member of speakers’ bureau; Daiichi- Sankyo, Eli Lilly, Novartis, YL Biologics, Bristol-Myers, Eisai, Chugai, Abbvie, Astellas, Pfizer, Sanofi, Asahi-kasei, GSK, Mitsubishi-Tanabe, Gilead, Janssen. Grants/research support; Abbvie, Mitsubishi-Tanabe, Chugai, Asahi-Kasei, Eisai, Takeda, Daiichi-Sankyo. P. Emery: Consultancies; AbbVie, BMS, Celltrion, Gilead, Lilly, Novartis, Roche, Samsung, and Sandoz. Grants/research support; AbbVie, BMS, Lilly, and Samsung. A. Pechonkina: Shareholder/stock ownership; employee and shareholder in Gilead Sciences, Inc. A. Kuo: Shareholder/stock ownership; employee and shareholder in Gilead Sciences, Inc. Q. Gong: Shareholder/stock ownership; employee and shareholder in Gilead Sciences, Inc. K. Van Beneden: Shareholder/stock ownership; employee of and shareholder in Galapagos, NV. V. Rajendran: Shareholder/stock ownership; employee of and shareholder in Galapagos, NV. H. Schulze-Koops: Consultancies; from AbbVie, Amgen, BMS, Celgene, Celltrion, Chugai, Gilead, Janssen, Eli Lilly and Company, Merck Sharp &amp; Dohme, Novartis- Sandoz, Pfizer, Roche, Sanofi. Grants/research support; AbbVie and Novartis.

DOP37 Efficacy and safety of filgotinib in patients with Ulcerative Colitis stratified by age: Post hoc analysis of the phase 2b/3 SELECTION and SELECTIONLTE studies

Abstract Background With a growing prevalence of inflammatory bowel disease (IBD) in elderly patients, there is a clinical requirement to understand the impact of treatment in this population.1 Filgotinib (FIL) is an oral Janus kinase 1 preferential inhibitor. This post hoc analysis of data collected in the phase 2b/3 SELECTION programme evaluated the efficacy and safety of FIL in patients with ulcerative colitis (UC) stratified by age. Methods The SELECTION programme includes two Induction Studies, a Maintenance Study (NCT02914522) and a long-term extension (LTE) study (NCT02914535). Adults aged 18–75 years with moderately to severely active UC were randomized 2:2:1 to receive FIL 200 mg or 100 mg or placebo once daily for 11 weeks. Responders at week 10 were re-randomized 2:1 to continue assigned FIL treatment or placebo from week 11–58. In LTE, patients with disease worsening and those completing week 58 continued assigned treatment before receiving open-label FIL. We assessed the efficacy and safety of FIL at any dose in the overall cohort of SELECTION and LTE, stratified into five age groups: &amp;lt;30, ≥30–&amp;lt;40, ≥40–&amp;lt;50, ≥50–&amp;lt;60 and ≥60 years. Clinical remission was evaluated at week 10 and pMCS remission was assessed at week 10, 58 and LTE weeks 2, 4, 12 and 24. Exposure-adjusted incidence rates (EAIRs) were calculated for adverse events (AEs). A data cut-off of 28 February 2020 was used. Results Baseline disease activity and previous and concomitant treatments were comparable across age groups in each treatment arm. While there were fewer patients in the ≥60 years group, patient distribution was similar in all other age groups. FIL induced clinical (~16%) and pMCS (~36%) remission in similar proportions of patients across all age groups at week 10 (Figure 1). At week 58, pMCS remission was achieved in ~53% of FIL-treated patients across age groups (Figure 2). In LTE, the proportion of FIL-treated patients in pMCS remission generally increased with time and remained similar across all age groups (Figure 3). FIL-treated patients aged ≥60 years had higher EAIRs of any AE, infections, herpes zoster, malignancies, NMSC and MACE than younger patients (Table). One thromboembolic event occurred in a FIL-treated patient aged &amp;lt;30 years. Three deaths related to cardiovascular disease occurred in FIL-treated patients aged ≥50 years. Conclusion These findings suggest FIL is efficacious in inducing and maintaining symptomatic remission and could have an acceptable safety profile in adults with UC of all ages, including ≥60 years old. Age-related increases in incidences of certain AEs might be expected in patients with IBD; however, the number of patients ≥60 years limits comparison of these data with reported rates. Reference 1Zammarchi et al. BMC Gastroenterol 2020;20;147

Evaluating filgotinib for the treatment of rheumatoid arthritis

ABSTRACT Introduction Despite the availability of an extensive armamentarium, rheumatoid arthritis (RA) remains a therapeutic challenge for rheumatologists. Janus kinase inhibitors (JAKi) are an emerging class of targeted therapies. The number of JAKi has been growing and to date, filgotinib is the latest JAKi to be approved for use in RA. Areas covered This review focuses on the pharmacodynamics, pharmacokinetics, efficacy and safety of filgotinib in patients with RA. Expert opinion Filgotinib is an oral targeted synthetic disease-modifying antirheumatic drug (DMARD) that specifically inhibits JAKi. Filgotinib monotherapy, or a combination regimen with conventional synthetic (cs) DMARDs, has demonstrated efficacy in decreasing disease activity, with a well-managed safety profile in patients with early RA naive to DMARDs, and in RA that does not adequately respond to csDMARDs and/or biologic DMARDs. The selective inhibition of JAK1 may confer an improved safety profile, but further study is required as a potential testicular toxicity has been suggested. Filgotinib offers several advantages: oral administration, rapidity of action, efficacy as monotherapy, and demonstrated activity in difficult to treat RA. However, the placement of filgotinib in the therapeutic arsenal for RA may be influenced by the ongoing collection of long-term safety data from JAKi as a class.

Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3

ObjectiveThis analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).MethodsThis was a post...

Comparative efficacy and safety of 100mg and 200 mg filgotinib administered to patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials .

We assessed the relative efficacy and safety of once-daily administration of 100 and 200 mg filgotinib (a JAK1-selective inhibitor) in patients with active rheumatoid arthritis (RA). We conducted a Bayesian network meta-analysis combining the direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of filgotinib in patients with active RA. Five RCTs involving 3,920 patients met the inclusion criteria. There were 15 pairwise comparisons, including 8 direct comparisons and 7 interventions. The ACR20 response rate was significantly higher in the filgotinib 200 mg + methotrexate (MTX) group than in the placebo or placebo + MTX group (odds ratio (OR): 12.39, 95% credible interval (CrI): 3.36-45.98.10; OR: 2.68, 95% CrI: 1.80-4.39). Compared to the placebo group, the filgotinib 100 mg, adalimumab 40 mg + MTX, filgotinib 200 mg, and placebo + MTX groups showed a significantly higher ACR20 response rate. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated filgotinib 200 mg + MTX was likely to achieve the best ACR20 response rate (SUCRA = 0.902), followed by filgotinib 100 mg + MTX (SUCRA = 0.694), filgotinib 100 mg (SUCRA = 0.675), adalimumab 40mg + MTX (SUCRA = 0.661), filgotinib 200 mg (SUCRA = 0.305), placebo + MTX (SUCRA = 0.259), and placebo (SUCRA = 0.005). The safety based on the number of serious adverse events (SAEs) did not differ significantly among 6 six interventions. Filgotinib 100 and 200 mg administration once daily in combination with MTX was the most efficacious intervention for active RA, with no significant risk of SAEs.

P219 Long-term safety of filgotinib in patients with PsA: week 52 safety data from a Phase 2 open-label extension study

Abstract Background Filgotinib (FIL) is an orally administered, selective janus kinase 1 (JAK1) inhibitor in development for psoriatic arthritis (PsA). Efficacy and safety of FIL in patients with active PsA were evaluated in a 16-week phase 2 study (EQUATOR, NCT03101670). After 16 weeks, patients could roll-over to an Open Label Extension (OLE) Study (EQUATOR2, NCT03320876) for the purpose of evaluating long-term safety and efficacy. The aim of this analysis was to assess safety and efficacy through 52 weeks of exposure to filgotinib. Methods Patients who completed the randomised, double-blind, placebo-controlled study were eligible for participation in the OLE, during which all patients received once daily (qd) open-label FIL 200mg. In this interim analysis of OLE, for the safety analysis, all data were included from the screening in the core study up to the data cut of 18 April 2019 in the OLE. For the efficacy analysis, all data until OLE Week 52 visit for each patient were included (observed case analysis). Results Of the 131 patients randomised and dosed in EQUATOR, 124 (95%) completed the study and 122 (93%) enrolled in EQUATOR2; 50% were female and mean age was 50. At this interim analysis, 106/122 (87%) remained in the OLE (premature discontinuations during OLE due to: 4 for safety, 11 withdrew consent, and 1 for other reasons). Cumulative patient years of exposure (PYE) on FIL were 160, median time on FIL was 66 weeks. Key safety data are summarised in Table 1. Key ≥Grade 2 treatment-emergent laboratory abnormalities seen with FIL arm (N = 128) compared with PBO (N = 66) were lymphocyte decrease 11.1% vs 4.5%, neutrophil decrease 5.5% vs 0%, ALT increase 1.6% vs 1.5% and creatinine increase 0.8% vs 0%, respectively. At week 52, 34% of the patients fulfilled criteria for minimal disease activity and 81%, 55%, and 33% of patients, respectively, achieved ACR20/50/70 responses. Conclusion FIL 200mg qd was generally well tolerated and the safety profile in PsA was comparable to that observed in the FIL rheumatoid arthritis studies. The data from this interim analysis suggest that further improvement of the patient condition can be expected beyond 16 weeks of treatment. Disclosures L. Coates: Other; Received support from Abbvie, Amgen, Celgene, Galapagos, Janssen, Lilly, Novartis, Pfizer, Prothena, Sun pharma, and UCB. P. Mease: Other; Received support from Abbvie, Amgen, BMS, Celgene, Galapagos, Genentech, Gilead, Janssen, Eli Lilly, Merck, Novartis, Pfizer, SUN, and UCB. D. Gladman: Other; Received support from Abbvie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, UCB, BMS, and Galapagos. F. Van den Bosch: Other; Received support from Abbvie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, and UCB. A. Rychlewska-Hanczewska: Other; Received support from Galapagos and Gilead Sciences. C. Tasset: Corporate appointments; Employee of Galapagos NV. L. Meuleners: Corporate appointments; Employee of Galapagos NV. M. Trivedi: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc... Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. R. Besuyen: Other; Employee of Galapagos NV. P. Helliwell: Other; Received support from Abbvie, Amgen, Celgene, Galapagos, Janssen, Novartis, Pfizer, and UCB.