Introduction: A better understanding of patient experience of intravenous (IV) or subcutaneous (SC) routes of administration is fundamental to providing optimal administration of medical therapies to oncology patients. The objective of this study was to examine patient experiences of IV and SC treatment with nivolumab and confirm the relevance of item concepts in the Patient Experience and Preference Questionnaire (PEPQ). The PEPQ is a clinical outcomes’ assessment instrument developed to obtain patient-centric data and understand the experience with IV and SC treatment administration.Methods: Embedded qualitative interviews were conducted with a subset of participants from three treatment cohorts with metastatic non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), unresectable or advanced metastatic melanoma, hepatocellular carcinoma (HCC), or colorectal cancer (CRC) from the CA209-8KX clinical trial. Concept elicitation interviews were conducted within 14 days of the initial treatment cycle and patient experiences with IV and SC treatment administration were assessed. Concepts from interviews were mapped to the PEPQ version 1.0 questions to assess relevance and convergence of concepts.Results: Interviews were conducted with 43 trial participants from clinical sites opting to participate from six countries (Argentina, France, the Netherlands, Poland, Spain, and New Zealand). The mean age of sub-study participants was 66 ± 11.3 years (range 24–80 years), and 67.4% (N = 29) were male. Sub-study participants with experience of SC most frequently reported symptoms or signs of injection-related redness (27.9%), itching (14.0%), and pain (of needle), and described the pain as pricking, stinging, or tingling (11.0% each). The amount of pain and time burden were widely endorsed as important factors for satisfaction and related to the route of medication administration. For 11 sub-study participants with experience with both IV and SC treatments, 10 (90.9%) preferred SC over IV treatment administration.Conclusion: This study summarizes the experience and satisfaction of receiving IV or SC treatment and confirms the relevance of the PEPQ in a subgroup of CA209-8KX clinical trial participants with metastatic NSCLC, RCC, melanoma, HCC, and CRC. Participant treatment experience and satisfaction with the route of medication mapped to the PEPQ question content support the relevance of PEPQ v2.0 in clinical trials as a self-report measure.
There is evidence of disparities in healthcare utilization for patients with atopic dermatitis (AD), but research exploring differences in patient treatment satisfaction and patient perception of interactions with their AD healthcare provider (HCP) by race and ethnicity is limited. The primary study objectives were to understand racial and ethnic differences in adult patients with AD for treatment use, treatment satisfaction, and patient perceptions on HCP interactions. Adult patients living with self-reported AD in the United States (US) were recruited through the National Eczema Association (NEA) and the AmeriSpeak panel, a national sample of US adults. Sampling targets were used to achieve condition-based population proportions across multiple racial and ethnic categories. Patients completed an 80- to 110-item electronic one-time survey including questions on overall AD severity over the last month, current AD treatment, current AD treatment satisfaction, AD provider type, and perceptions of their interactions with HCPs. Data are reported using descriptive statistics. Overall, 260 patients (NEA n=18; AmeriSpeak n=242) completed the survey (mean age 40.6 years; 66.2% female; 55.0% White, 23.5% Black/African American, 11.5% Asian, and 10.0% American Indian/Alaskan Native, Native Hawaiian or Other Pacific Islander, or multiple-races (i.e. other races (OtR)); 13.5% Hispanic/Latino). Nearly half (49.6%) reported severity as mild, 43.1% moderate, and 7.3% severe. Overall, 63.8% of patients were using over-the-counter ointments/creams/lotions/gels for their AD, while 62.6% were using prescription creams/lotions. 28.2% reported being dissatisfied/very dissatisfied with their current treatment regimen, with treatment dissatisfaction was highest among Black/African American patients (36.2%) and lowest among OtR patients (21.7%). Additionally, 22.6% of patients reported that in the past year they or a household member had been unable to get medicine or any healthcare (medical, dental, mental health, vision); this was reported by 32.2% Black/African American, 21.1% White, 19.2% OtR, 13.3% Asian, 20.0% Hispanic/Latino, and 23.0% Non-Hispanic/Non-Latino. 49.2% indicated that a dermatologist was the provider they primarily saw for medications to treat their AD. This was followed by primary care providers (33.1%), those who did not see a provider for their AD (10.4%), and allergists (4.2%). Of those who indicated they saw a provider for their AD, 39.1% of patients report their HCP listened to their AD concerns ‘somewhat’ or ‘a little bit’; Asian (61.6%), White (38.9%), Black/African American (32.7%), and OtR (30.4%). 43.3% of Hispanic/Latino and 38.5% of Non-Hispanic/Non-Latino patients reported their HCP listened ‘somewhat’ or ‘a little bit.’ Only 1.3% of all patients reported their HCPs did not listen to their concerns ‘at all.’ When asked how much they thought their AD HCP understood their perspective on their AD, 42.4% of all patients chose ‘somewhat’ or ‘a little bit.’ This was reported by 46.2% Asian patients, 44.4% White patients, 41.7% OtR patients, 36.4% Black/African American patients, 53.1% Hispanic/Latino patients, and 40.7% Non-Hispanic/Non-Latino patients. Additionally, 42.1% of all patients reported they ‘somewhat’ or ‘a little bit’ trust that their HCP effectively treats their AD. This was reported by 50.0% Asian patients, 45.3% White patients, 34.6% Black/African American patients, 33.3% OtR patients, 43.8% Hispanic/Latino patients, and 41.8% Non-Hispanic/Non-Latino patients. Overall, 3% of patients reported they did not trust their HCP to effectively treat their AD ‘at all’ and 1.3% reported their HCPs did not understand their perspective ‘at all.’ Nearly a quarter of patients living with AD reported not being able to access medicine or healthcare in the past year. Although there were differences in the percentages reported by race and ethnicity, some patients indicated there were gaps with regards to the patient-physician relationship around not feeling completely listened to, understood, or trusting HCPs treating AD. These findings may help inform clinical practice considerations in AD.
IntroductionPatients with relapsed or refractory multiple myeloma (RRMM) are likely to be living with persistent symptoms, especially bone pain and fatigue, and experiencing restrictions in their physical and social functioning, which reduce health-related quality of life.MethodsThis qualitative interview study evaluated patients’ perspectives about living with RRMM and their treatment with belantamab mafodotin, using interviews embedded in the Phase II DREAMM-2 trial (NCT03525678) with belantamab mafodotin. Patients consented to participate in up to 2 recorded telephone interviews (at treatment cycle 4 [C4] and at end of treatment [EOT]) comprising open-ended questions.ResultsA total of 142 interviews were conducted with 111 unique patients. At C4, common symptoms included neuropathy, fatigue, and bone or joint pain. Improvements in symptom severity were reported by patients who responded to belantamab mafodotin. Symptoms associated with visual impairment, eye irritation, and eye pain reported during the trial were reported to be at- or near-resolution by the EOT interview. Regarding impacts of underlying MM, patients most commonly expressed concerns about changes in daily performance and lifestyle for both responders (67.5% of all impact expressions) and non-responders (63.2%). Overall, interview participants reported being satisfied with belantamab mafodotin treatment.DiscussionThis qualitative patient interview study provides valuable insight into patients’ symptomatic experience with belantamab mafodotin for their RRMM treatment and may help healthcare providers better anticipate their patients’ real-world experience and needs when prescribing this novel agent in the clinic.
Objective Patients with atopic dermatitis (AD) have low treatment satisfaction. In this study, we evaluated the humanistic burden, treatment satisfaction, and treatment expectations in patients with AD in the United States. Methods Adults with AD recruited through the National Eczema Association and clinical sites completed a web-based survey comprising the Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD), Dermatology Life Quality Index; Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis; Treatment Satisfaction Questionnaire for Medication (TSQM); and answered questions on healthcare provider (HCP) visits, treatment history, and treatment goals. Descriptive analyses were performed to compare participants by severity. Results Among 186 participants (mean [standard deviation] age 39.7 [15.3] years, 79.6% female), 26.9%, 44.6%, and 26.3% of the participants had mild, moderate, or severe AD, respectively, based on PO-SCORAD. Greater disease severity was associated with a greater impact on work and daily life, decreased TSQM scores, and increased HCP visits. Corticosteroid topical cream or ointment (53.8%) and oral antihistamines (31.2%) were most commonly used for the treatment of AD. Participants reported declining/stopping/changing AD treatment due to the potential for side effects or lack of efficacy. ‘Leading normal lives’ (28.0%) and ‘being itch-free’ (33.9%) were important treatment goals. Conclusions Individuals with AD, especially severe disease, face a considerable humanistic burden even while using treatment.
Introduction Sickle cell disease (SCD) is a genetic vascular disease that causes pain, fatigue and multiple complications, ultimately affecting health-related quality of life of patients (Osunkwo et al. Am J Hematol 2021). The purpose of this study was to conduct qualitative interviews to inform the development of a patient reported outcome (PRO) daily diary to capture key symptoms and impacts of vaso-occlusive crisis (VOCs) experienced at home, based on methods consistent with US Food and Drug Administration (FDA) guidance for incorporating patient input and clinical outcome assessments into clinical research (FDA Fed Reg 2009, FDA PFDD Draft Guidance 3 2022). Methods This was a cross-sectional, non-interventional, qualitative study involving 16 concept elicitation (CE) interviews with adults (18-65 years), 15 cognitive interviews with adults (two rounds of n=12 and n=3), and 8 hybrid CE/cognitive interviews with adolescents (12-17 years). Up to 50% of adult participants were able to participate in both CE and cognitive interviews. Adult participants were recruited by clinical sites in the United States (US) and adolescent participants were recruited by a recruitment vendor. Patients were eligible to participate if they had a confirmed diagnosis of SCD, at least two VOCs in the past 12 months, a hemoglobin level of ≥4 gm/dL in past six months, and did not have a blood transfusion in the past three months. All interviews were conducted in English according to the approved study protocol and interview guide. Key symptoms and impacts were identified during CE interviews as those that were reported by at least 75% of sample and experienced daily by at least 50% of sample. The daily diary items were refined based on cognitive interviews to ensure patient understanding, medical expert input (n=1) and medical expert advisory board input (n=4) to ensure clinical relevance. Results Adult CE and cognitive interview participants (n=25 unique participants, with 6 participating in both CE and cognitive interviews) were mostly female (n=18; 72.0%), with a mean age of 38.0 ± 9.4 years (range 20 to 56 years). Among adolescent participants, nearly all were female (n=7, 87.5%), with a mean age of 14.6 ± 2.1 years (range 12 to 17 years). All adult and adolescent participants self-identified as African American. Twenty percent (n=5) of adult participants had a history of taking crizanlizumab-tmca, 16.0% (n=4) had a history of taking voxelotor, 8.0% (n=2) had a history of taking both, and 56.0% (n=14) had never taken crizanlizumab-tmca or voxelotor. Twelve and a half percent (n=1) of adolescent participants had a history of taking crizanlizumab-tmca, 50.0% (n=4) had a history of taking voxelotor, and 37.5% (n=3) had never taken crizanlizumab-tmca or voxelotor. Findings from CE interviews identified the following key concepts: pain severity, pain crisis, tiredness, stiffness, impact on daily activities, impact on work or school, and impact on sleep. Four items were included based on medical expert/advisory board input to address swelling, ability to keep up with peers (for adolescents only), ability to control pain, and overall SCD severity. The current draft PRO daily diary includes four symptoms, four SCD-related impacts, and overall SCD severity, which will undergo further qualitative testing. Conclusion Results from this qualitative study provides further insight into the daily experience of patients with SCD, including their experience with pain crises. Findings from this study were used to develop a daily diary PRO tool for use in future clinical trials. Future work includes additional CE/cognitive interview with adults and adolescents to refine the PRO as needed and establish content validity and psychometric validation.
Objective: Atopic dermatitis (AD) is a common, chronic, flaring, inflammatory skin disease causing a variety of dermatologic signs and symptoms. While treatment options are available, they are of variable effectiveness. This study sought to describe patient-reported current treatment utilization and continued disease burden.
Introduction: Belantamab mafodotin (belamaf) has been available for treatment of patients with relapsed/refractory multiple myeloma (RRMM) in clinical practice since US approval in August 2020. Single-agent belamaf, a first-in-class B-cell maturation antigen-binding antibody-drug conjugate containing monomethyl auristatin F (MMAF) with a multimodal mechanism of action, showed deep and durable responses in the pivotal Phase II DREAMM-2 trial (NCT03525678). This study aimed to describe patients' perspectives of living with RRMM and their treatment with belamaf, based on interviews conducted in a real-world setting, supplemented by findings from interviews embedded into the DREAMM-2 trial. Methods: Semi-structured interviews were conducted with adults with RRMM receiving belamaf in real-world clinical practice and those enrolled in the DREAMM-2 trial. Real-world interviews were conducted with eligible patients who had received commercially supplied belamaf in routine care, per label, for ≥3 months prior to recruitment or had discontinued treatment within the past year and had received treatment for ≥3 months. Eligible patients for the real-world study were identified by SparkCures, a patient engagement partner that works closely with patients to help identify and explore potential clinical trial options. In the real-world study, interviews were conducted at a single time-point with patients describing how their MM and treatment-related symptoms had changed over time since starting belamaf; patients recalled bothersomeness of symptoms before starting belamaf, "at symptom worst" and "at time of interview". In DREAMM-2, patients were interviewed at Cycle 4 (C4; 2.5 and 3.4 mg/kg Q3W) and at the end of treatment (EOT); at the EOT interview, patients recalled severity of symptoms "at symptom worst" and "at time of interview". Bothersomeness (real-world study) and severity (DREAMM-2) were rated using a numeric rating scale (0=no bother/not severe; 10=extremely bothersome/severe). The DREAMM-2 trial-embedded study included all eligible patients who agreed to participate in interviews. Patients' experiences with belamaf were also qualitatively explored. Real-world study interviews are ongoing; interim findings are reported. Results: Patients who participated in real-world interviews (n=7; male 4 of 7; median 65 years; median 11 months of belamaf treatment) and patients enrolled in DREAMM-2 who participated in EOT interviews (n=38; male 20 of 38 patients; median 63.5 years) were included. Fatigue was the most frequently reported ongoing RRMM symptom in both studies (real-world: 6 of 7 patients; DREAMM-2 EOT: 22 of 38 patients). Within respective studies, mean bothersomeness/severity of most ongoing symptoms was substantially reduced "at time of interview" compared with "at worst" (Table 1). The type of ocular symptoms reported in both studies were similar and included sensitivity to light, blurred vision, and poor vision. Within respective studies, the bothersomeness/severity of patients' ocular symptoms was generally rated lower "at time of interview" compared with "at worst" occurrence (Table 2). To alleviate ocular symptoms, patients in both studies reported applying eye drops and wearing sunglasses. In the real-world study, 6 of 7 patients indicated that the benefits of belamaf treatment outweighed the treatment-related ocular changes, while 5 of 7 patients reported a preference for belamaf over past treatments. In DREAMM-2, 27 patients made ≥1 positive statement about belamaf treatment. Conclusions: These qualitative interviews provide insights into the burden of disease-related symptoms experienced by patients with RRMM treated with belamaf. Insights from DREAMM-2 support the interim real-world findings that ongoing symptoms become less bothersome/severe over time with belamaf treatment. In both settings, patients described the benefits of belamaf and their positive opinion of its efficacy/safety profile. These findings suggest patients find belamaf an important treatment option for RRMM. Funding: GSK 214290 and GSK 205678; drug linker technology licensed from Seagen Inc.; mAb produced using POTELLIGENT Technology licensed from BioWa. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal
PURPOSE:To describe symptoms and side effects experienced by patients with advanced non-small cell lung cancer (NSCLC), assess how patients allocate sensations (i.e. symptoms or side effects) to either the disease or its treatment, and evaluate how patients balance side effects with treatment benefits.METHODS:Qualitative sub-studies were conducted as part of two clinical trials in patients treated for advanced NSCLC (AURA [NCT01802632]; ARCTIC [NCT02352948]).RESULTS:Interviews were conducted with 23 patients and 19 patients in the AURA and ARCTIC sub-studies, respectively. The most commonly experienced symptoms/side effects were respiratory (81% of patients), digestive (76%), pain and discomfort (76%), energy-related (71%), and sensory (62%). Patients identified a sensation as a treatment side effect if they had not experienced it before, if there was a temporal link between the sensation and receipt of treatment, and/or if their doctors consistently told or asked them about it in relation to side effects. Themes that emerged when patients talked about their cancer treatment and its side effects related to the serious nature of their advanced disease and their treatment expectations. Patients focused on treatment benefits, wanting a better quality of life, being hopeful, not really having a choice, and not thinking about side effects.CONCLUSIONS:In these two qualitative sub-studies, patients with advanced NSCLC valued the benefits of their treatment regardless of side effects that they experienced. Patients weighed their options against the seriousness of their disease and expressed their willingness to tolerate their side effects in return for receiving continued treatment benefits.
BACKGROUND:Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease causing a variety of dermatologic signs and symptoms, affecting patient’s quality of life. While treatment options are available, they are of variable effectiveness. This study sought to characterize patient-reported AD signs and symptoms, flare, and associated bother, by disease severity and control. METHODS:Adults diagnosed with AD were recruited through the National Eczema Association (NEA) and clinical sites and completed a web-based survey including the Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD), Recap of Atopic Eczema (RECAP), and Skin Pain numeric rating scale (NRS), as well as questions on previous/current clinical presentation, flare frequency and severity, past/ present AD treatment, and sociodemographic characteristics. RESULTS:A total of 186 participants completed the survey (mean age 39.7 years, 80% female). The most frequently reported current AD signs and symptoms included dryness, itch, redness, roughness, and flaking skin, and the most bothersome were itch, dryness, and redness (63%). The majority of participants (84%) were either currently experiencing a flare or had experienced one within the past month. The most common signs and symptoms that grew worse during the most recent flare were itch and redness across all disease severity groups. Participants most often experienced one to three flares in the last three months. Flare frequency, duration, and average severity increased with greater disease severity and lack of disease control. CONCLUSIONS:The results of this study demonstrate the diverse and considerable symptomatic burden experienced by people with AD, even while being treated for AD. J Drugs Dermatol. 2021;20(11):1222-1230. doi:10.36849/JDD.6329.
e20531 Background: Patient-reported outcomes in RRMM remain poor, particularly for those refractory to immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies, and there is an increased risk of cumulative toxicities in these patients. Single-agent belantamab mafodotin (GSK2857916), a first-in-class, B-cell maturation antigen–binding immunoconjugate, has demonstrated deep and durable responses with a manageable safety profile in heavily pretreated patients with RRMM (DREAMM-1, NCT02064387). Here, we present patient-reported clinical benefit/tolerability of belantamab mafodotin evaluated by trial-embedded end-of-treatment (EOT) and follow-up interviews. Methods: DREAMM-1 study design and results have been reported ( Blood Cancer J 2019). Patients in the Part 2 expansion phase were administered single-agent belantamab mafodotin 3.4 mg/kg IV once every 3 weeks for 16 cycles and invited to participate in interviews at EOT and 6-month follow-up. Patients discussed symptoms, treatment-related adverse events (AEs), treatment burden, and overall treatment satisfaction, rated 0–10 (0 = not severe to 10 = most severe/0 = not at all satisfied to 10 = extremely satisfied). Results: A total of 17/35 patients (9 female [53%]) were interviewed; 4/17 patients completed both interviews. Most patients (94%; 16/17) achieved a partial response or better. At EOT, patients reported an improvement from the worst point in symptoms of bone pain (mean change in score from 6.4 to 4.0) and fatigue (8.0 to 5.5). The most commonly reported treatment-related AE was blurred vision (76%; 13/17). Among those reporting this AE, 62% (8/13) reported resolution or steady improvement in vision after EOT; with a reduction in severity rating from 7.3 at worst to 5.3 at EOT for this event. Most patients (93%; 13/14) never considered stopping treatment owing to AEs, including ocular events. Overall treatment satisfaction was high (mean score 7.9; median 9.0). Conclusions: Despite small sample sizes, trial-embedded interviews provide valuable insight into patient experience with belantamab mafodotin. Patients treated with single-agent belantamab mafodotin reported high treatment satisfaction and improvements in symptoms. Visual symptoms were frequent but manageable, and improved or resolved after treatment. Funding: GlaxoSmithKline (117159). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Clinical trial information: NCT02064387.
Introduction: Patients refractory to an immunomodulatory agent and a proteasome inhibitor, and relapsed/refractory to an anti-CD38 antibody, are a population with a high unmet need given the poor prognosis in this setting. Single-agent belamaf (GSK2857916), a B-cell maturation antigen-binding antibody-drug conjugate, has demonstrated deep and durable responses with a manageable safety profile in heavily pretreated patients with RRMM. We used qualitative interviews to understand the patient perspective on clinical benefits and tolerability of belamaf. Methods: Patients enrolled in the DREAMM-2 study (NCT03525678) received single-agent belamaf 2.5 or 3.4 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. All were invited to participate in interviews at Cycle 4 (C4) and end of treatment (EOT). If the patient discontinued treatment before C4, only one interview was conducted. Interview questions covered the patient symptom experience, treatment-related burden, and adverse events. Disease and treatment-related symptom severity and overall treatment satisfaction were rated 0-10 (0=not severe to 10=most severe/0=not at all satisfied to 10=extremely satisfied). Qualitative and quantitative analyses were conducted with interview results and select variables from the clinical trial dataset. Results: A total of 104 patients (across both doses) participated in interviews before or at C4, with 56% (n=58) identified as responders to treatment (≥partial response by International Myeloma Working Group criteria). Among the 104, the most commonly reported disease symptoms were fatigue (reported by 68% of patients), neuropathy (43%), and bone pain (37%). Responders reported a decrease in severity of these symptoms from the start of the study to the time of interview, with ratings changing from 6.9 to 3.6 (bone pain), 4.6 to 3.4 (fatigue), and 4.5 to 3.7 (neuropathy). The severity ratings for nonresponders increased slightly for fatigue (4.4 to 4.5) and decreased for bone pain (4.9 to 4.4) and neuropathy (3.9 to 2.8). Fifty-nine (57%) patients interviewed at or before C4 reported visual impairments, including poor vision, blurred vision, and sensitivity to light, while 42 (40%) reported symptoms of eye irritation, including irritated eyes, dry eyes, itchy eyes, and the feeling of something in the eye. Twelve (12%) patients reported eye pain, including sore eyes and burning at or before C4. Responders interviewed before or at C4 reported a mean treatment satisfaction of 8.5, while nonresponders reported their satisfaction at 5.1. A total of 26 patients were interviewed at EOT after C4, 22 (85%) of whom were responders to treatment. Patients interviewed at EOT reported decreased severity in their ocular symptoms between the time when the symptoms were at their worst and the 2-week period prior to their interview. Between worst symptoms and interview, participant severity ratings showed a decrease from 8.0 to 0.0 (for eye pain; n=4), 7.2 to 1.8 (for eye irritation; n=11), and 8.1 to 2.9 (for visual impairment; n=17). All 26 patients interviewed at EOT indicated they expected the ocular side effects they experienced. Six patients considered stopping treatment due to their ocular symptoms, two of whom reported their doctor discontinued treatment for this reason. At EOT, these 26 patients reported high treatment satisfaction, with responders rating their satisfaction higher than nonresponders (8.1 and 6.7, respectively). Conclusions: Trial-embedded interviews provide valuable insights into the patient experience with their disease, the course of treatment-related side effects, and their overall impact on patient satisfaction with treatment. Overall, responders to treatment with single-agent belamaf reported more improvement than nonresponders in key disease symptoms, including bone pain and fatigue. Many patients reported some type of ocular symptom, but these were shown to improve or resolve by EOT. Despite ocular symptoms, overall, patients reported high satisfaction while on treatment and a desire to remain on treatment, particularly in responders. These qualitative interviews, in addition to the efficacy data, support the use of belamaf in patients with RRMM. Funding: GSK 205678; drug linker technology licensed from Seattle Genetics; mAb produced using POTELLIGENT Technology licensed from BioWa. Disclosures Eliason: GSK: Current Employment, Current equity holder in publicly-traded company. Correll:Evidera: Current Employment. Martin:Evidera: Current Employment. Cardellino:GSK: Current Employment, Current equity holder in publicly-traded company. Opalinska:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Piontek:GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Gorsh:GSK: Current Employment, Current equity holder in publicly-traded company. Sapra:GSK: Current Employment, Current equity holder in publicly-traded company. Popat:AbbVie: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Takeda: Consultancy, Honoraria, Other: Travel support, Research Funding; GSK: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company).