Author Interviews, COVID -19 Coronavirus, Dermatology, Respiratory / 06.10.2021

MedicalResearch.com Interview with: [caption id="attachment_58209" align="alignleft" width="200"]Lara van der Schoot  MD, PhD candidate Department of Dermatology Radboud University Medical Center Nijmegen, The Netherlands Lara van der Schoot[/caption] Lara van der Schoot  MD, PhD candidate Department of Dermatology Radboud University Medical Center Nijmegen, The Netherlands MedicalResearch.com: What is the background for this study? Response: Psoriasis is a chronic, immune mediated skin disease for which effective targeted biological agents have become available the past years. Inherent to their immunomodulatory mechanism of action, biologics might increase infections risk. We know from clinical trial data that respiratory tract infections are among the most common adverse events during biologic treatment, but real-world data is sparse. Regarding the risk of serious infections among biologic users, mostly defined as infections requiring hospitalization, previous studies provided different results and there is limited comparative data for the newer biologics available. The COVID-19 pandemic turned attention to the risk of infections among biologic users, especially for respiratory tract infections, as they might relate to susceptibility for viral respiratory tract infections such as COVID-19. In our study, the primary aim was to determine the risk of respiratory tract infections among real-world psoriasis patients treated with biologics, including the newer IL-17 and IL-23 inhibitors. The secondary aim was to assess risk of serious infections in this cohort. Additionally, rates of SARS-CoV-2 infections were assessed.
Asthma, Author Interviews / 03.11.2020

MedicalResearch.com Interview with: https://www.gsk.com/en-gb/home/Beth Hahn, PhD, Director U.S. Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, NC MedicalResearch.com: What is the background for this study? Response: Biologic therapies are increasing as a treatment for patients with severe asthma, with multiple therapies approved by the FDA.  There is also an increasing understanding of the factors influencing preference for and adherence to biologic therapies for patients with severe asthma; however, little is known about why patients discontinue biologic therapy. In patients who have access to biologic treatment, understanding the circumstances and asthma characteristics associated with discontinuation of biologic therapy may allow for the identification of barriers to treatment success . The objective of this study of cross-sectional physician and patient survey data was to assess the patient characteristics and the given reasons for treatment discontinuation in a US patient cohort with severe asthma treated with biologic therapy. A total of 117 physicians and 285 patients completed surveys with 70% of patients continuing biologic therapy (N=200). This study included a number of different FDA approved biologics. From the perspectives of the physicians included in the current study (85 providing a rationale for discontinuation), the majority reported a lack of symptom control, particularly shortness of breath (46%), exacerbations (26%) and other chronic symptoms (29%), as a key reason for discontinuing biologic therapy in severe asthma. Symptom control was also key for patients, with these three symptom categories among their top six reasons for biologic discontinuation. The cost of biologic treatment was also an important factor, cited as the 5th most common reason for discontinuation among physicians and the 3rd among patients.
Author Interviews, Brigham & Women's - Harvard, Dermatology, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48184" align="alignleft" width="200"]Seoyoung C. Kim, MD, ScD, MSCEDirector, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology Associate Professor of MedicineDivision of Pharmacoepidemiology & PharmacoeconomicsDivision of Rheumatology, Immunology and Allergy Brigham and Women's Hospital, Harvard Medical School Dr. Kim[/caption] Seoyoung C. Kim, MD, ScD, MSCE Director, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology Associate Professor of Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Division of Rheumatology, Immunology and Allergy Brigham and Women's Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effect of different treatment agents on CV risk. As the number of treatment options for psoriasis and psoriatic arthritis has been rising over the few decades, it is even more crucial to have high-quality evidence on comparative safety of different treatment options so physicians and patients can choose an agent based on the benefit-risk profile of each drug they are considering.
Asthma, AstraZeneca, Author Interviews, Pulmonary Disease / 22.11.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Sean O'Quinn MPH Director, Patient Reported Outcomes AstraZeneca  MedicalResearch.com: What is the background for this study? How does benralizumab differ from traditional medications for asthma? Response:  FASENRA™ (benralizumab 30mg for subcutaneous injection as add-on maintenance therapy in severe eosinophilic asthma for patients 12 years and older) has a strong clinical profile, including powerful efficacy against exacerbations and the ability to improve lung function. Benralizumab is a respiratory biologic that binds directly to the IL-5α receptor on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis. (NOTE: The mechanism of action of FASENRA in asthma has not been definitively established.) Benralizumab is not indicated for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus. The most common adverse reactions include headache and pharyngitis. Dependence on rescue medications is indicative of poor asthma control. In the Phase III SIROCCO/CALIMA trials, patients with severe eosinophilic asthma had significantly reduced exacerbation frequency and improved lung function when treated with benralizumab 30mg Q8W (first three doses Q4W) vs. placebo. Less was known about the effects of benralizumab on rescue medication usage—specifically daily total rescue medication use, daytime and nighttime rescue medication use, and nighttime awakenings requiring rescue medication use. The aim of this analysis was to understand the potential treatment effects of benralizumab on these parameters. 
Author Interviews, Dermatology, JAMA / 30.05.2018

MedicalResearch.com Interview with: [caption id="attachment_42016" align="alignleft" width="180"]Andrew Blauvelt, M.D., M.B.A. President Oregon Medical Research Center  Dr. Blauvelt[/caption] Andrew Blauvelt, M.D., M.B.A. President Oregon Medical Research Center  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This new paper focuses on treatment of psoriasis in classically difficult-to-treat areas of the body, which include the scalp, the palms/soles, and the fingernails. We show that guselkumab, which is a new biologic therapy that selectively targets IL-23 (a key pro-inflammatory cytokine in psoriasis pathogenesis), works well in these areas affected by psoriasis. More specifically, after 6 months of treatment with guselkumab, approximately 85%, 80%, and 60% of patients achieved complete or near complete clearance of psoriasis in their scalp, palms/soles, and fingernails, respectively. 
Author Interviews, Dermatology, Eli Lilly, Sexual Health / 07.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40411" align="alignleft" width="120"]Dr. Jennifer Cather MD Medical Director at Modern Dermatology and Modern Research Associate Dallas, Texas  Dr. Cather[/caption] Dr. Jennifer Cather MD Medical Director at Modern Dermatology and Modern Research Associate Dallas, Texas  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Genital psoriasis can be an uncomfortable and burdensome condition that many people living with moderate-to-severe plaque psoriasis experience. Due to the significant impact, Lilly conducted a 12-week Phase 3b clinical trial with patients with moderate-to-severe genital psoriasis treated with ixekizumab, which found that patients had a greater decrease in the impact of their condition on sexual activity compared to placebo as early as one week. Specifically, trial patients were randomized to receive ixekizumab (80 mg every two weeks, following a 160-mg starting dose) or placebo and researchers measured pre-specified patient-reported outcomes, including the Genital Psoriasis Sexual Impact Scale (GPSIS), which is composed of the Sexual Activity Avoidance (Avoidance) and Impact of Sexual Activity on Genital Psoriasis Symptoms (Impact) subscales. Patient-reported outcomes were also measured by the Sexual Frequency Questionnaire (SFQ) item 2, evaluating the impact of genital psoriasis on the frequency of sexual activity, and the Dermatology Life Quality Index (DLQI) item 9, evaluating the impact of skin symptoms on sexual difficulties. At 12 weeks, patients reported the following outcomes:
  • DLQI Item 9 0/1: 92.0 percent of patients treated with ixekizumab compared to 56.8 percent of patients treated with placebo reported no (0) or little (1) sexual difficulties caused by skin symptoms.
  • SFQ Item 2 0/1:  78.4 percent of patients treated with ixekizumab compared to 21.4 percent of patients treated with placebo (reported the frequency of sexual activity was either never (0) or rarely (1) limited by genital psoriasis.
  • GPSIS-Avoidance 1/2:  76.7 percent of patients treated with ixekizumab compared to 25.7 percent of patients treated with placebo reported never (1) or rarely (2) avoiding sexual activity due to genital psoriasis.
  • GPSIS-Impact 1/2:  85.7 percent of patients treated with ixekizumab compared to 52.9 percent of patients treated with placebo reported worsening of genital psoriasis symptoms during or after sexual activity was very low/none at all (1) or low (2). 
Author Interviews, Gastrointestinal Disease, JAMA, Lymphoma / 08.11.2017

MedicalResearch.com Interview with: ANSMRosemary Dray-Spira, MD, PhD Department of Epidemiology French National Agency for Medicines and Health Products Safety (ANSM) Saint-Denis, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: Anti-tumor necrosis factor (anti-TNF) agents are increasingly used for the management of inflammatory bowel diseases (IBD), either alone or in combination with thiopurines. Their clinical benefits have been largely assessed, however they may expose to potentially serious adverse effects. While an increased risk of lymphoma has been established with thiopurines, up to now such a risk of lymphoma remained uncertain with anti-TNF agents. In this study based upon a large, nationwide cohort of 189,289 patients with IBD, the use of anti-TNF agents alone was found associated with a 2 to 3 fold increase in the risk of lymphoma, similarly to thiopurines alone. In addition, the combination of these two treatments was associated with a 6 fold increase in the risk of lymphoma, ie a higher risk than with each treatment used alone. Although these differences are statistically significant, the risk of lymphoma among patients exposed to anti-TNF agents is less than 1 case per 1000 person-years.
Author Interviews, Lancet, Rheumatology, UT Southwestern / 20.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35455" align="alignleft" width="150"]Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231 Dr. Fleischmann[/caption] Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the phase 3 studies of tofacitinib, it was noted that the clinical responses to tofacitinib monotherapy were higher than the responses to tofaciotinib plus MTX and that tofacitinib plus methotrexate had numerically higher clinical responses compared to adalimumab plus methotrexate. This study was a non-inferiority design which compared tofacitinib monotherapy to tofacitinib + MTX and to adalimumab +MTX and tofacitinib monotherapy to tofacitinib +MTX in MTX incomplete responders. It was found that tofacitinib + MTX is non-inferior to adalimumab + MTX (and vice versa) and neither was superior to the other. The results of tofacitinib to either combination was non-conclusive showing neither non-inferiority or inferiority, but suggesting that either combination will be effective in more patients in a group of patients.
Author Interviews, Inflammation, JAMA / 20.04.2017

MedicalResearch.com Interview with: Andrew Dick FRSB FMedSci Professor of Ophthalmology Bristol Eye Hospital, University of Bristol, Bristol, England National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital, Institute of Ophthalmology, University College London, London, England and John Sheppard, MD President, Virginia Eye Consultants Professor of Ophthalmology, Eastern Virginia Medical School MedicalResearch.com: What should readers take away from your report? Dr. Andrew Dick: These findings demonstrate that adalimumab is associated with clinically meaningful improvements in visual functioning for patients with non-infectious intermediate uveitis, posterior uveitis, and panuveitis. The emphasis of this work is that for the first time in uveitis we have seen patient reported outcome benefit of a biologic treatment. This analysis supports the use of adalimumab as a promising new treatment option, having demonstrated improvements in both clinical and visual functioning outcomes in patients with active and inactive uveitis. Dr. John Sheppard: Uveitis has a substantial effect on individuals’ physical, professional, psychological, avocational and social functioning in day-to-day life. Adalimumab, an anti-inflammatory drug that binds to tumor necrosis factor, was recently approved for the treatment of non-infectious intermediate uveitis, posterior uveitis, and panuveitis. It is the first systemic therapy specifically approved for uveitis.  The analyses in this study provide evidence that patients with noninfectious uveitis treated with adalimumab experience significant and clinically meaningful improvements in vision-related quality of life, compared with those who received placebo.
Author Interviews / 11.03.2017

MedicalResearch.com Interview with: [caption id="attachment_15640" align="alignleft" width="99"]Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung] Prof. Reich[/caption]Prof. Dr. med. Kristian Reich Dermatologie, Allergologie Psoriasis- und Neurodermitis-Trainer Hamburg MedicalResearch.com: What is the background for this study? What are the main findings? Response: The IXORA-S study compared the efficacy and safety of Taltz® (ixekizumab) and Stelara®* (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis at 24 weeks. In this study, patients were randomized to receive either Stelara (45 mg or 90 mg weight-based dosing per label) or Taltz (80 mg every two weeks followed by 80 mg every four weeks), following an initial starting dose of 160 mg. At 24 weeks, patients treated with Taltz achieved significantly higher response rates compared to patients treated with Stelara, including 83 percent of patients who achieved Psoriasis Area Severity Index (PASI) 90—the study’s primary endpoint—compared to 59 percent of patients who achieved PASI 90 after treatment with Stelara. Results at 24 weeks also found: • 91.2 percent of patients treated with Taltz achieved PASI 75 compared to 81.9 percent of patients treated with Stelara (p=0.015) • 49.3 percent of patients treated with Taltz achieved PASI 100 compared to 23.5 percent of patients treated with Stelara (p=0.001) • 86.6 percent of patients treated with Taltz achieve static Physician’s Global Assessment score (sPGA) 0 or 1 compared to 69.3 percent of patients treated with Stelara (p<0.001) The majority of treatment-emergent adverse events were mild or moderate. There were no statistically significant differences between treatment groups in overall treatment-emergent adverse events. The safety profile for Taltz was consistent with previous clinical trials.
Author Interviews, JAMA, Pharmacology, Rheumatology / 23.09.2016

MedicalResearch.com Interview with: Jacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, FranceJacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is no recommendation for the choice of the second biologic in patients with rheumatoid arthritis and insufficient response to a first anti-TNF, which is a common situation in our daily practice (approximately one third of patients treated with anti-TNF). We therefore conducted the first randomized trial to date to investigate the best strategy in such a setting.
Annals Internal Medicine, Author Interviews, Dermatology, Gastrointestinal Disease, Immunotherapy / 09.12.2015

[caption id="attachment_19875" align="alignleft" width="180"]Isabelle Cleynen PhD University of Leuven Dr. Cleynen[/caption] MedicalResearch.com Interview with: Isabelle Cleynen  PhD University of Leuven  Medical Research: What is the background for this study? What are the main findings? Dr. Cleynen : Ulcerative colitis and Crohn’s disease, together inflammatory bowel disease (IBD), are characterized by chronic inflammation of the gastrointestinal tract. Treatment for IBD usually involves drug therapy including anti-inflammatory drugs and immune system repressors, amongst which biologics as the anti-TNF antibodies used for patients with moderate to severe IBD. Although these TNF-blocking drugs are effective in many patients with immune-mediated disorders like psoriasis, rheumatoid arthritis and spondylarthropathies, and IBD, several case reports and series showed that some patients developed troubling skin problems (including psoriasis and eczema), causing them to stop the anti-TNF treatment. It is however not clear how often these skin problems develop in IBD patients treated with anti-TNF, and what could be the predisposing factors. In a retrospective cohort of 917 IBD patients initiated on anti-TNF therapy in a single center, we have studied which patients did and did not develop skin problems, what type of skin problems, how they were treated, and whether the lesions resolved upon treatment. We found that about one third of the patients developed skin problems while being treated with anti-TNF drugs. The most common type was psoriasiform eczema, often occurring in flexural regions, the scalp, and genitalia. The time between starting the TNF-blocking drug and the appearance of the skin problem varied from less than half a year to more than 4 years. Quite surprisingly, we found that the cumulative dose of the treatment, or drug serum levels were not different in skin and non-skin lesion patients. Skin lesion patients however seemed to be younger when diagnosed with IBD and when started on anti-TNF agents, more often had anti-nuclear and dsDNA antibodies (both auto-immune factors), and a higher number of skin-disease related genetic risk variants. Most patients had a good response to treatment of their skin problem. About 10% of the patients who developed skin problems, however, stopped the TNF-blocking treatment because of this issue.
Author Interviews, Dermatology / 25.08.2015

William W. Huang, MD, MPH Assistant Professor and Program Director Wake Forest School of Medicine Department of Dermatology Winston-Salem, NC 27104MedicalResearch.com Interview with: William W. Huang, MD, MPH Assistant Professor and Program Director Wake Forest School of Medicine Department of Dermatology Winston-Salem, NC 27104 Medical Research: What is the background for this study? What are the main findings? Dr. Huang: This particular study was an update of a previous study our group had published in 2008 (JAAD, 6/08). As the use of biologics in dermatology has increased dramatically in recent years, we wanted to evaluate the evidence for the screening and monitoring tests that are routinely performed for patients with psoriasis and psoriatic arthritis on biologic agents. We found that current guidelines for screening and monitoring tests varied among various national organizations (Table 1) including the American Academy of Dermatology, Japanese Dermatology Association, European Academy of Dermatology and Venerology, and the British Association of Dermatologists. Using evidence grading based on methods developed by the US Preventative Services Task Force (USPSTF), we found that the evidence was strongest (Grade B) for tuberculosis screening. High level evidence was in general lacking for other routine screening and monitoring tests except in select populations (Table 2, Table 3).
Author Interviews, Dermatology, NEJM / 10.07.2015

Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung] MedicalResearch.com Interview with: Prof. Dr. med. Kristian Reich DERMATOLOGIKUM HAMBURG Hamburg Medical Research: What is the background for this study? What are the main findings? Prof. Reich: The Phase 2b X-PLORE study compared a new generation biologic therapy, guselkumab - an inhibitor of IL–23, with the anti–tumor necrosis factor (TNF)–alpha agent adalimumab (Humira®) and placebo in the treatment of moderate-to-severe plaque-type psoriasis. It showed that up to 86 percent of patients treated with guselkumab achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study’s primary endpoint.  Interestingly, levels of efficacy were higher for several guselkumab doses through week 16 when compared to adalimumab. Improvements with guselkumab continued through week 40 with every eight- or twelve-week maintenance treatment.  
Author Interviews, Outcomes & Safety, Rheumatology / 15.06.2015

MedicalResearch.com Interview with: Cécile Gaujoux-Viala, MD, PhD Université Montpellier I Chef de Service de Rhumatologie CHU de Nîmes Carémeau France Medical Research: What is the background for this study? Response: Chronic inflammatory rheumatic diseases – such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)  – confer significant patient and economic burdens : 1/5 of people with rheumatic conditions has been forced to change career, 1/3 will have stopped working within two years of onset and 1/2 will be unable to work within ten years. The addition of biological agents in treatment strategies for rheumatic diseases have improved the possibility of controlling disease activity and slowing the progression of joint damage. But these treatments are very expensive and their effect on work participation remains unclear.
Author Interviews, Dermatology, JAMA / 26.05.2015

MedicalResearch.com Interview with: Robert E Kalb, M.D. Clinical Professor of Dermatology State University of New York at Buffalo School of Medicine and Biomedical Sciences Buffalo Medical Group, P.C. Buffalo, NY 14221MedicalResearch.com Interview with: Robert E Kalb, M.D. Clinical Professor of Dermatology State University of New York at Buffalo School of Medicine and Biomedical Sciences Buffalo Medical Group, P.C. Buffalo, NY 14221 Medical Research: What is the background for this study? What are the main findings? Dr. Kalb: It's important to evaluate the safety of biologics in the real world post-marketing setting, and in particular with respect to serious infections. We studied patients with psoriasis in the PSOLAR registry and evaluated the risk of various biologic therapies. We found that infliximab and adalimumab were associated with increased risk of serious infections when compared with non-biologic/non-methotrexate therapies, while ustekinumab and etanercept were not associated with increased risk.
Author Interviews, Dermatology / 22.03.2015

MedicalResearch.com Interview with: Steven R. Feldman, M.D., Ph.D. Professor of Dermatology Wake Forest Baptist Medical Center Winston-Salem, NC Medical Research: What is the background for this study? What are the main findings? Response: Results show that introducing apremilast into the treatment pathway prior to biologics is cost-saving and confers a cost and quality of life benefit. Over 10 years, apremilast was estimated to provide an additional 0.74 years (5.00 vs. 4.26 years) in which patients achieved a 75% reduction from baseline in PASI score, compared to a pathway of biologics only. It was also found to be less costly, mainly due to less time spent on more expensive biologic therapy (costs reduced by $9,072.39 over 10 years).
Author Interviews, NEJM, Rheumatology / 06.11.2014

Professor Paul Emery Arthritis Research UK Professor of Rheumatology Director - Leeds Musculoskeletal Biomedical Research Unit, LTHT Director – Leeds Institute of Rheumatic and Musculoskeletal Medicine University of LeedsMedicalResearch.com Interview Professor Paul Emery Arthritis Research UK Professor of Rheumatology Director - Leeds Musculoskeletal Biomedical Research Unit, LTHT Director – Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds Medical Research: What is the background for this study? What are the main findings? Professor Emery: Joint damage and functional disability are common in people who suffer from rheumatoid arthritis (RA), even in those with early disease. We know that early aggressive treatment with biologics, such as the anti-TNF agent etanercept, results in rapid remission in many patients with moderate-to-severe rheumatoid arthritis, which can help reduce the risk of joint destruction and disability long term. However, we don’t yet know whether remission achieved with biologic therapy can be maintained after doses are reduced or therapy is withdrawn. The PRIZE trial, a “state-of-the-art” biologic treatment trial conducted in adults with early untreated rheumatoid arthritis, was designed to fill this knowledge gap. The trial included three phases:
  • 1) induction therapy with full-dose combination etanercept-methotrexate therapy;
  • 2) maintenance therapy with a reduced-dose etanercept-methotrexate regimen, methotrexate alone, or no treatment; and
  • 3) complete treatment withdrawal. After clinical remission was induced, remission was shown to be effectively maintained with the reduced-dose combination regimen but not with the biologic-free regimens.Significantly more patients who had received the reduced-dose regimen were in remission after therapy was withdrawn than patients who received no therapy after remission induction. Interestingly, however, after remission was induced with the full-dose combination regimen, no substantial progression of joint damage on x-ray was seen in patients receiving the reduced-dose regimen, methotrexate only, or no treatment.
Author Interviews, Infections, NIH, Rheumatology / 31.03.2014

MedicalResearch.com Interview with: Eleftherios Mylonakis, M.D., Ph.D., FIDSA Dean's Professor of Medical Science Chief, Infectious Diseases Division Alpert Medical School and Brown University and Dr. Irene Kourbeti MD Research Associate Infectious Disease Division Rhode Island Hospital, Providence, RI MedicalResearch.com: What are the main findings of the study? Answer : There was high quality of evidence that biologic agents are associated with increased risk of all opportunistic infections, but there was no difference in mortality attributed to the opportunistic infections. Patients receiving biologics were twice more likely to develop opportunistic infections (OIs) compared to controls (OR 1.79; 95% CI, 1.17-2.74) with a number needed to harm (NNH) of 582 patients. That means that 1 opportunistic infection  would occur in every 582 patients receiving biologics. The opportunistic infections usually occurred at the commencement of the use of the biological agent and they were not statistically more in patients with a previous exposure to anti-TNF agents as compared to the patients that had never received an anti-TNF agent..
Author Interviews, Heart Disease, Rheumatology / 29.10.2013

MedicalResearch.com Interview with: Lotta Ljung, MD, PhD Umeå University, Umeå and Karolinska  Institute Stockholm, Sweden MedicalResearch.com: What are the main findings of the study? Dr. Ljung:  In this observational study we observed a lower risk of acute coronary syndromes in a cohort of patients with rheumatoid arthritis (RA) exposed to tumor necrosis factor inhibitors (TNFi) compared with the risk among patients without this exposure. The adjusted relative risk (HR) was 0.73-0.82  among TNFi exposed patients compared with the biologics-naive RA cohort, depending on the time frame evaluated, which can be concluded as a moderately lower risk. Compared with the risk in the general population, the risk in RA patients was higher, whether exposed to TNFi or not.
Author Interviews, BMJ, Case Western, Rheumatology / 29.08.2013

Dr Janet E Pope Division of Rheumatology, Department of Medicine The University of Western Ontario, St Joseph's Health Centre 268 Grosvenor Street, London, ON, Canada N6A 4V2MedicalResearch.com Interview with: Dr. Janet E Pope Division of Rheumatology, Department of Medicine The University of Western Ontario, St Joseph's Health Centre 268 Grosvenor Street, London, ON, Canada N6A 4V2   MedicalResearch.com: What are the main findings of the study?  Dr. Pope: We performed a RCT of patients who were stable for 6 months of etanercept added to methotrexate (inadequate responders to Mtx) who were randomized to stopping Mtx or continuing Mtx to determine if in the next 6 months (and later as the trial continues) the response rate would be the same if Mtx was discontinued. Overall, Mtx + etanercept was not statistically equivalent to etanercept alone (ie non-inferiority did not occur); implying 6 months after stopping Mtx, the etanercept patients on monotherapy performed slightly less well than those on combination therapy.