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Darrell E White,1 Yang Zhao,2 Hemalatha Jayapalan,3 Pattabhi Machiraju,3 Ramu Periyasamy,3 Abayomi Ogundele2 1SkyVision Centers, Westlake, OH, USA; 2Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA; 3Indegene, Inc., Bangalore, IndiaCorrespondence: Abayomi OgundeleMedical Affairs, Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540, USAEmail abayomi.ogundele@sunpharma.comPurpose: To assess patient satisfaction among current and former users of the anti-inflammatory topical medications, cyclosporine A 0.05% (CYC) and lifitegrast 5.0% (LIF), for the management of dry eye disease (DED).Patients and Methods: Patients with DED were recruited via physician referral to participate in a survey. Current users of CYC or LIF were asked to rate their experience in terms of satisfaction, side effects, and limitation of activities. Switchers of CYC to LIF or LIF to CYC were asked to rate the importance of potential reasons for switching.Results: Surveys were completed by 207 patients currently treated with CYC (n=98), LIF (n=96), or other DED medications (n=13). Although overall satisfaction with current treatment was high, current users of CYC and LIF reported ineffective relief of DED symptoms (31% and 22%, respectively) and dissatisfaction with the time to onset of effect (29% and 11%). Substantial proportions of patients reported ‘sometimes’, “usually”, or ‘always’ experiencing the following side effects: burning sensation (72% CYC, 64% LIF), itching (43% CYC, 44% LIF), altered sensation of taste (21% CYC, 56% LIF), blurred vision (37% CYC, 50% LIF), and discharge (28% CYC, 30% LIF). Of the 30 switchers of CYC to LIF and 31 switchers of LIF to CYC, the majority reported inability to relieve DED symptoms as a very or extremely important switching reason. Despite switching, one in four patients were somewhat dissatisfied or dissatisfied with their current medication, with 37% of patients reporting ineffective symptom relief.Conclusion: Although the rate of overall satisfaction was generally high with both LIF and CYC, many patients were unable to achieve effective symptom relief and commonly experienced side effects. The proportion of patients who were dissatisfied and/or unable to achieve effective symptom relief even after switching suggests the need for additional treatment options for managing DED.Keywords: patient satisfaction, dry eye disease, cyclosporine, lifitegrast, ocular surface

Supplemental material, sj-docx-1-opp-10.1177_10781552221103551 for Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma by Maria-Victoria Mateos, Sophie Rigaudeau, Supratik Basu, Ivan Spicka, Rik Schots, Tomasz Wrobel, Gordon Cook, Meral Beksac, Katharine S Gries, Anupa Kudva, Brenda Tromp, Rian Van Rampelbergh, Huiling Pei, Susan Wroblewski, Robin Carson, Maria Delioukina and Darrell White in Journal of Oncology Pharmacy Practice

Objective We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged 65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance

BACKGROUND Elotuzumab plus lenalidomide and dexamethasone has shown improved progression-free and overall survival versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. We aimed to assess these regimens in patients with newly diagnosed multiple myeloma who are ineligible for haematopoietic stem-cell transplantation (HSCT). METHODS ELOQUENT-1 is an open-label, multicentre, randomised, phase 3 trial conducted at 185 hospitals, oncology practices, and research centres in 19 countries. Eligible patients were aged 18 years or older with newly diagnosed, untreated, symptomatic myeloma and not candidates for high-dose therapy plus HSCT, and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower. Patients were randomly assigned (1:1) to receive elotuzumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone using an interactive voice response system, stratified by the International Staging System (ISS; stage I-II vs III), age (

Supplemental material, sj-docx-1-opp-10.1177_10781552221103551 for Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma by Maria-Victoria Mateos, Sophie Rigaudeau, Supratik Basu, Ivan Spicka, Rik Schots, Tomasz Wrobel, Gordon Cook, Meral Beksac, Katharine S Gries, Anupa Kudva, Brenda Tromp, Rian Van Rampelbergh, Huiling Pei, Susan Wroblewski, Robin Carson, Maria Delioukina and Darrell White in Journal of Oncology Pharmacy Practice

Darrell E White,1 Yang Zhao,2 Abayomi Ogundele,2 Nicole Fulcher,3 Annabel Acs,3 Laura Moore-Schiltz,3 Paul M Karpecki4 1Department of Ophthalmology, SkyVision Centers, Westlake, OH 44145, USA; 2Health Economics and Outcomes Research, Sun Pharmaceutical Industries, Princeton, NJ 08540, USA; 3Outcomes Research, IBM Watson Health, Cambridge, MA 02142, USA; 4Corneal Services and Advanced OSD Clinic, University of Pikeville Kentucky College of Optometry, Pikeville, KY 41501, USACorrespondence: Yang ZhaoHealth Economics and Outcomes Research, Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540, USATel +1 609 720 8132Email yang.zhao@sunpharma.comPurpose: To assess adherence, non-persistence, discontinuation, and switching of topical cyclosporine ophthalmic emulsion 0.05% (CYC) and lifitegrast ophthalmic solution 5% (LIF) use in the real world among patients with dry eye disease (DED).Design: Retrospective insurance claims study.Methods: Adult patients with DED and ≥1 prescription claim for CYC or LIF (first claim = index date) in the IBM® MarketScan® databases from July 2016 to February 2018 were identified. Eligible patients had continuous medical and pharmacy benefits in the 12 months pre- and post-index periods, and no prior use of the index medication. The proportion of days covered (PDC), adherence, non-persistence, discontinuation, and switching were examined over the 12-month post-index period.Results: This study included 6537 CYC and 3235 LIF patients. The adherence rate was 5.9% for CYC and 9.7% for LIF; the median PDC was 0.3 for both cohorts. Overall, 70.8% of CYC and 64.4% of LIF patients discontinued treatment with median days to discontinuation of 89 and 29, respectively. Non-persistence was 7.1% for CYC and 6.8% for LIF (median days to discontinuation: 89 and 105). In addition, 5.0% switched from CYC to LIF, and 9.6% switched from LIF to CYC over the post-index period.Conclusion: Over 60% of DED patients discontinued treatment within 12 months of initiation; the median time to discontinuation was 3 months for CYC and 1 month for LIF. Although this analysis did not capture the reasons why patients discontinued treatment, the results demonstrate there likely exists a significant unmet need amongst DED patients.Keywords: dry eye disease, adherence, persistence, cyclosporine ophthalmic emulsion, lifitegrast ophthalmic solution

Background As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged >= 18 years) with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1) to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of beta(2) microglobulin at screening. Bortezomib (1.3 mg/m(2)) was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1,4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years]) was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1-14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings Between Jan 7, 2013, and May 15,2017,559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15.9 months (IQR 9.9-21.7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11.20 months [95% CI 9.66-13-73] vs 7.10 months [5.88-8-48]; hazard ratio 0.61, 95% CI 0.49-0-77; p

Darrell E White,1 Yang Zhao,2 Hemalatha Jayapalan,3 Pattabhi Machiraju,3 Ramu Periyasamy,3 Abayomi Ogundele2 1SkyVision Centers, Westlake, OH, USA; 2Medical Affairs, Sun Pharmaceutical Industries, Princeton, NJ, USA; 3Medical Services, Indegene, Inc, Bangalore, IndiaCorrespondence: Abayomi OgundeleMedical Affairs, Sun Pharmaceutical Industries, Inc, 2 Independence Way, Princeton, NJ 08540, USAEmail abayomi.ogundele@sunpharma.comPurpose: Dry eye disease (DED) is one of the most common ophthalmic disorders. Pathogenesis of the disease includes inflammation of the ocular surface and lacrimal gland. Two anti-inflammatory prescription treatments are currently available: cyclosporine ophthalmic emulsion 0.05% (CYC) and lifitegrast 5% ophthalmic solution (LIF). The objective of this survey-based study was to assess physician satisfaction with CYC and LIF for the treatment of DED.Methods: Physicians currently treating DED patients with CYC or LIF were asked to rate the experiences of their patients currently or formerly using CYC and LIF, and their own perspectives on the two treatments.Results: Twenty-one physicians participated in the survey, providing responses on behalf of 210 patients. Overall, physicians reported low levels of satisfaction with onset of action of CYC and LIF, and fewer than half considered either drug to be effective in managing symptoms or improving patient quality of life (QoL). Burning sensation and dysgeusia were the most frequently reported side effects. Onset of action and effectiveness after onset were the main switching drivers. Although two-thirds of physicians were satisfied with the overall effectiveness of CYC and LIF, all physicians agreed that more DED treatment options are needed, with > 50% strongly agreeing.Conclusion: Physicians perceived a gap in DED management with currently available topical anti-inflammatory agents. Although satisfaction with CYC and LIF was high, few physicians considered these medications to be effective in managing symptoms or improving QoL.Keywords: physician satisfaction, dry eye disease, cyclosporine, lifitegrast, ocular surface

Elizabeth Yeu,1 Damien F Goldberg,2 Francis S Mah,3 Kenneth A Beckman,4,5 Jodi I Luchs,6,7 Jonathan D Solomon,8 Darrell E White,9 Preeya K Gupta101Eastern Virginia Medical School, Virginia Eye Consultants, Norfolk, VA, USA; 2Wolstan & Goldberg Eye Associates, Torrance, CA, USA; 3Scripps Clinic Torrey Pines, La Jolla, CA, USA; 4Ohio State University, Columbus, OH, USA; 5Comprehensive Eye Care of Central Ohio, Westerville, OH, USA; 6Hofstra Northwell School of Medicine, Hempstead, NY, USA; 7South Shore Eye Care, Wantagh, NY, USA; 8Bowie Vision Institute, Bowie, MD, USA; 9Skyvision Centers, Westlake, OH, USA; 10Duke University Eye Center, Durham, NC, USAPurpose: Evaluate the safety and efficacy of cryopreserved amniotic cytokine extract (ACE) in the treatment of subjects with dry eye disease (DED).Patients and methods: This was a retrospective, multicenter, chart review of adult patients with DED that instilled cryopreserved ACE drops twice-daily for 4 or 12 weeks. Patients had corneal fluorescein staining (0–20 range) and/or a lissamine green conjunctival staining score (0–18 range) of ≥3 and ≤9 in at least 1 eye and a score ≥40 (0–100 range) of eye dryness/irritation on a visual analog scale (VAS). Following completion of a treatment course, medical records were reviewed from the initiation of therapy (baseline), and at post-treatment visits (4 weeks, 8 weeks, and 12 weeks). Patient records for visual acuity, adverse events, corneal fluorescein staining, conjunctival lissamine green staining, and symptom scores of ocular dryness/irritation were reviewed for each visit, as available. Safety and tolerability were assessed through the evaluation of patient-reported adverse events recorded in the medical records.Results: A total of 54 eligible patients were identified at 7 clinical sites; 16 patients administered ACE drops for 4-weeks, and 38 patients instilled ACE drops for 12 weeks. Significant improvements in the mean changes from baseline were observed for corneal fluorescein staining, lissamine green staining, visual acuity (LogMar) and VAS ocular symptom scores at the 4-week post-treatment visit (p

BACKGROUND: The combination melphalan-prednisone-thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches. METHODS: We randomly assigned 1623 patients to lenalidomide and dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus MPT. RESULTS: The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P

Background Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic antimyeloma activity when combined with bortezomib and dexamethasone. We aimed to compare panobinostat, bortezomib, and dexamethasone with placebo, bortezomib, and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. Methods PANORAMA1 is a multicentre, randomised, placebo-controlled, double-blind phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma who have received between one and three previous treatment regimens. Patients were randomly assigned (1:1) via an interactive web-based and voice response system, stratified by number of previous treatment lines and by previous use of bortezomib, to receive 21 day cycles of placebo or panobinostat (20 mg; on days 1, 3, 5, 8, 10, 12, orally), both in combination with bortezomib (1.3 mg/m(2) on days 1, 4, 8, 11, intravenously) and dexamethasone (20 mg on days 1, 2, 4, 5, 8, 9, 11, 12, orally). Patients, physicians, and the investigators who did the data analysis were masked to treatment allocation; crossover was not permitted. The primary endpoint was progression-free survival (in accordance with modified European Group for Blood and Marrow Transplantation criteria and based on investigators’ assessment) and was analysed by intention to treat. The study is ongoing, but no longer recruiting, and is registered at ClinicalTrials.gov, number NCT01023308. Findings 768 patients were enrolled between Jan 21, 2010, and Feb 29, 2012, with 387 randomly assigned to panobinostat, bortezomib, and dexamethasone and 381 to placebo, bortezomib, and dexamethasone. Median follow-up was 6.47 months (IQR 1.81-13.47) in the panobinostat group and 5.59 months (2.14-11.30) in the placebo group. Median progression-free survival was significantly longer in the panobinostat group than in the placebo group (11.99 months [95% CI 10.33-12.94] vs 8.08 months [7.56-9.23]; hazard ratio [HR] 0.63, 95% CI 0.52-0.76; p