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5. Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis

Author

Chang, Ih, primary, Kappos, Ludwig, additional, Giovannoni, Gavin, additional, Calabresi, Peter A, additional, Sandrock, Alfred, additional, Cheng, Wenting, additional, Xiao, Shan, additional, Riester, Katherine, additional, Belachew, Shibeshih, additional, Deykin, Aaron, additional, and Zhu, Bing, additional

Published
2022
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6. sj-pdf-1-msj-10.1177_13524585221114997 – Supplemental material for Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis

Author

Chang, Ih, Kappos, Ludwig, Giovannoni, Gavin, Calabresi, Peter A, Sandrock, Alfred, Cheng, Wenting, Xiao, Shan, Riester, Katherine, Belachew, Shibeshih, Deykin, Aaron, and Zhu, Bing

Subjects
FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, sj-pdf-1-msj-10.1177_13524585221114997 for Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis by Ih Chang, Ludwig Kappos, Gavin Giovannoni, Peter A Calabresi, Alfred Sandrock, Wenting Cheng, Shan Xiao, Katherine Riester, Shibeshih Belachew, Aaron Deykin and Bing Zhu in Multiple Sclerosis Journal

Published
2022
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11. Next‐generation Bruton's tyrosine kinase inhibitor BIIB091 selectively and potently inhibits B cell and Fc receptor signaling and downstream functions in B cells and myeloid cells

Author

Bame, Eris, primary, Tang, Hao, additional, Burns, Jeremy C, additional, Arefayene, Million, additional, Michelsen, Klaus, additional, Ma, Bin, additional, Marx, Isaac, additional, Prince, Robin, additional, Roach, Allie M, additional, Poreci, Urjana, additional, Donaldson, Douglas, additional, Cullen, Patrick, additional, Casey, Fergal, additional, Zhu, Jing, additional, Carlile, Thomas M, additional, Sangurdekar, Dipen, additional, Zhang, Baohong, additional, Trapa, Patrick, additional, Santoro, Joseph, additional, Muragan, Param, additional, Pellerin, Alex, additional, Rubino, Stephen, additional, Gianni, Davide, additional, Bajrami, Bekim, additional, Peng, Xiaomei, additional, Coppell, Alex, additional, Riester, Katherine, additional, Belachew, Shibeshih, additional, Mehta, Devangi, additional, Palte, Mike, additional, Hopkins, Brian T, additional, Scaramozza, Matthew, additional, Franchimont, Nathalie, additional, and Mingueneau, Michael, additional

Published
2021
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13. Effect of dimethyl fumarate on lymphocyte subsets in patients with relapsing multiple sclerosis

Author

Buckle, Guy, primary, Bandari, Daniel, additional, Greenstein, Jeffrey, additional, Gudesblatt, Mark, additional, Khatri, Bhupendra, additional, Kita, Mariko, additional, Repovic, Pavle, additional, Riser, Emily, additional, Weinstock-Guttman, Bianca, additional, Thrower, Ben, additional, Loring, Sherrill, additional, Riester, Katherine, additional, Everage, Nick, additional, Prada, Claudia, additional, Koulinska, Irene, additional, and Mann, Monica, additional

Published
2020
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15. Among Real-world Multiple Sclerosis Patients That Experience Delayed-release Dimethyl Fumarate-associated Lymphopenia, Meaningful Lymphocyte Reconstitution Occurs Approximately 3 Months After Discontinuation of Delayed-release Dimethyl Fumarate (P4.2-017)

Author

Rose, John, primary, Alvarez, Enrique, additional, Okuda, Darin, additional, Gudesblatt, Mark, additional, Riser, Emily, additional, Spelman, Timothy, additional, Fam, Sami, additional, Riester, Katherine, additional, Wu, Fan, additional, Miller, Catherine, additional, and Butzkueven, Helmut, additional

Published
2019
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16. Prevalence and predictors of squamous cell abnormalities in Papanicolaou smears from women infected with HIV-1

Author

Massad, L. Stewart, Riester, Katherine A., Anastos, Kathryn M., Fruchter, Rachel G., Palefsky, Joel M., Burk, Robert D., Burns, David, Greenblatt, Ruth M., Muderspach, Laila I., and Miotti, Paolo

Subjects
Cervix dysplasia -- Causes of, HIV infection -- Complications, Health
Abstract

Women infected with HIV are more likely to have an abnormal Pap smear than non-infected women. In a study of 1,713 HIV-infected women and 482 non-infected women, 38% of the HIV-infected women had an abnormal Pap smear compared to 16% of the non-infected women. However, only 2.5% of the HIV-infected women had precancerous changes. Low CD4 T cell counts, high blood viral levels, human papillomavirus infection and many sexual partners were all risk factors for an abnormal Pap smear.

Published
1999

17. Cervical dysplasia on cervicovaginal Papanicolaou smear among HIV-1-infected pregnant and nonpregnant women

Author

Stratton, Pamela, Gupta, Prabodh, Riester, Katherine, Fox, Harold, Zorrilla, Carmen, Tuomala, Ruth, Eriksen, Nancy, Vajaranant, Mark, Minkoff, Howard, and Fowler, Mary Glenn

Subjects
HIV infection in women -- Testing, Pap test, Precancerous conditions -- Physiological aspects, Health
Abstract

The use of Pap smears to test a group of HIV-infected women, both pregnant and non-pregnant, showed a high incidence of low grade squamous intaepithelial lesions, but a low incidence the high grade variety. There were no cases of cervical cancer detected. In testing 426 nonpregnant and 126 pregnant HIV-infected women via Pap smear, these were the results, indicating that pregnancy may not be a factor in creating Pap smear abnormalities. However, the presence of squamous intraepithelial lesions raise a warning for closer examination and followup as it is associated with cervical inflammation, herpes simplex, and immunosuppression.

Published
1999

18. Comparative Effectiveness of Dimethyl Fumarate Versus Fingolimod and Teriflunomide on the Risk of Relapse in MS Patients Switching from First-Generation Platform Therapies in the US (P1.374)

Author

Nicholas, Jacqueline, primary, Carraro, Matthew, additional, Ontaneda, Daniel, additional, Zhou, Jia, additional, Hou, Qiang, additional, Babb, Jaanai, additional, Riester, Katherine, additional, Mendoza, Jason, additional, Livingston, Terrie, additional, and Jhaveri, Mehul, additional

Published
2018
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20. Characterization of Baseline Lymphocytes and Their Influence on Subsequent ALC and Lymphocyte Subset Decline in Patients with Relapsing Multiple Sclerosis Treated with Delayed-release Dimethyl Fumarate in a Retrospective, Multicenter, Observational Study (REALIZE) (P5.376)

Author

Buckle, Guy, primary, Bandari, Daniel, additional, Greenstein, Jeffrey, additional, Gudesblatt, Mark, additional, Khatri, Bhupendra, additional, Kita, Mariko, additional, Repovic, Pavle, additional, Riser, Emily, additional, Weinstock-Guttman, Bianca, additional, Riester, Katherine, additional, Everage, Nicholas, additional, Von Hehn, Christian, additional, and Mann, Monica, additional

Published
2017
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21. MRI Outcomes at Seven Years in Relapsing-Remitting Multiple Sclerosis Patients Treated With Delayed-release Dimethyl Fumarate in DEFINE, CONFIRM, and ENDORSE (S12.002)

Author

Arnold, Douglas L, primary, Fox, Robert J, additional, Gold, Ralf, additional, Havrdova, Eva, additional, Kappos, Ludwig, additional, Yousry, Tarek, additional, MacManus, David, additional, Yang, Lili, additional, Riester, Katherine, additional, Taylor, Catherine, additional, and Fay, Monica, additional

Published
2017
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25. Improved cognitive outcomes in patients with relapsing–remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study.

Author

Benedict, Ralph H. B., Cohan, Stanley, Lynch, Sharon G., Riester, Katherine, Wang, Ping, Castro-Borrero, Wanda, Elkins, Jacob, and Sabatella, Guido

Subjects
COGNITIVE ability, MULTIPLE sclerosis, INTRAMUSCULAR injections, INTERFERONS, INTERFERON beta 1b
Abstract

Background: Cognitive impairment is common in multiple sclerosis (MS), with cognitive processing speed being the most frequently affected domain. Objective: Examine the effects of daclizumab beta versus intramuscular (IM) interferon (IFN) beta-1a on cognitive processing speed as assessed by Symbol Digit Modalities Test (SDMT). Methods: In DECIDE, patients with relapsing–remitting multiple sclerosis (RRMS) (age: 18–55 years; Expanded Disability Status Scale (EDSS) score 0–5.0) were randomized to daclizumab beta (n = 919) or IM IFN beta-1a (n = 922) for 96–144 weeks. SDMT was administered at baseline and at 24-week intervals. Results: At week 96, significantly greater mean improvement from baseline in SDMT was observed with daclizumab beta versus IM IFN beta-1a (p = 0.0274). Significantly more patients treated with daclizumab beta showed clinically meaningful improvement in SDMT (increase from baseline of ⩾3 points (p = 0.0153) or ⩾4 points (p = 0.0366)), and significantly fewer patients showed clinically meaningful worsening (decrease from baseline of ⩾3 points (p = 0.0103)). Odds representing risk of worsening versus stability or improvement on SDMT were significantly smaller for daclizumab beta (p = 0.0088 (3-point threshold); p = 0.0267 (4-point threshold)). In patients completing 144 weeks of treatment, the effects of daclizumab beta were generally sustained. Conclusion: These results provide evidence for a benefit of daclizumab beta versus IM IFN beta-1a on cognitive processing speed in RRMS. Trial registration: ClinicalTrials.gov identifier NCT01064401 (Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis (DECIDE)): https://clinicaltrials.gov/ct2/show/NCT01064401. [ABSTRACT FROM AUTHOR]

Published
2018
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28. Daclizumab HYP Versus Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis: Primary Results of the DECIDE Study (S4.003)

Author

Kappos, Ludwig, primary, Selmaj, Krzysztof, additional, Arnold, Douglas, additional, Havrdova, Eva, additional, Boyko, Alexey, additional, Kaufman, Michael, additional, Wiendl, Heinz, additional, Rose, John, additional, Greenberg, Steven, additional, Sweetser, Marianne, additional, Riester, Katherine, additional, and Elkins, Jacob, additional

Published
2015
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29. Daclizumab HYP Reduced Brain MRI Lesion Activity Compared With Interferon Beta-1a: Results from the DECIDE Study (P7.252)

Author

Rose, John, primary, Wiendl, Heinz, additional, Arnold, Douglas, additional, Kappos, Ludwig, additional, Havrdova, Eva, additional, Selmaj, Krzysztof, additional, Boyko, Alexey, additional, Kaufman, Michael, additional, Greenberg, Steven, additional, Sweetser, Marianne, additional, Riester, Katherine, additional, and Elkins, Jacob, additional

Published
2015
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31. Safety and Tolerability Results From the DECIDE Study: A Phase 3 Active-Comparator Study of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis (P7.230)

Author

Selmaj, Krzysztof, primary, Kappos, Ludwig, additional, Arnold, Douglas, additional, Havrdova, Eva, additional, Boyko, Alexey, additional, Kaufman, Michael, additional, Wiendl, Heinz, additional, Rose, John, additional, Greenberg, Steven, additional, Riester, Katherine, additional, Sweetser, Marianne, additional, and Elkins, Jacob, additional

Published
2015
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40. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial

Author

Gold, Ralf, primary, Giovannoni, Gavin, additional, Selmaj, Krzysztof, additional, Havrdova, Eva, additional, Montalban, Xavier, additional, Radue, Ernst-Wilhelm, additional, Stefoski, Dusan, additional, Robinson, Randy, additional, Riester, Katherine, additional, Rana, Jitesh, additional, Elkins, Jacob, additional, and O'Neill, Gilmore, additional

Published
2013
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44. Eight-year immunogenicity and safety of interferon beta-1a-Avonex®treatment in patients with multiple sclerosis

Author

Herndon, Robert M, primary, Rudick, Richard A, additional, Munschauer, Frederick E, additional, Mass, Michele K, additional, Salazar, Andres M, additional, Coats, Michael E, additional, Labutta, Robert, additional, Richert, John R, additional, Cohan, Stanley L, additional, Genain, Claude, additional, Goodkin, Donald, additional, Toal, Martin, additional, and Riester, Katherine, additional

Published
2005
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49. Relapse rates and enhancing lesions in a phase II trial of natalizumab in multiple sclerosis.

Author

O'Connor, Paul, Miller, David, Riester, Katherine, Minhua Yang, Panzara, Michael, Dalton, Catherine, Miszkiel, Katherine, Khan, Omar, Rice, George, and Sheremata, William

Subjects
MULTIPLE sclerosis, MYELIN sheath diseases, CENTRAL nervous system, DISEASE relapse, PATIENTS, CLINICAL trials
Abstract

Background: Natalizumab, a humanized monoclonal IgG4 antibody, is an α4-integrin antagonist, which inhibits the migration of inflammatory cells into the central nervous system, a key pathogenic mechanism in multiple sclerosis (MS). In a six month, phase II clinical trial of patients with relapsing MS, natalizumab significantly reduced the formation of new gadolinium-enhanced (Gd+) lesions and the number of clinical relapses. Objective: To investigate the relationship of historical relapse rate and new Gd+ lesion number with subsequent MS disease activity and natalizumab treatment in the phase II study. Methods: Patients who participated in the phase II study were stratified into subgroups according to: (i) the number of relapses in the two years prior to entry into the study: 2 relapses (n = 108), 3 relapses (n =57), and >3 relapses (n =48); (ii) the number of new Gd+ lesions at baseline (Month 0): 0 (n = 129), 1-2 (n =50), and >2 (n =33). Relapses and new Gd+ lesions during the treatment phase of the trial were determined and compared for each subgroup. Results: Both the prestudy relapse rate and number of new Gd+ lesions at baseline were related to the subsequent risk of a relapse; baseline number of Gd+ lesions was related to the likelihood of subsequent new Gd+ lesion formation. There was a lower proportion of subjects with an on-study relapse and fewer new Gd+ lesions in all natalizumab-treated subgroups when compared with their placebo counterpart; the difference was most apparent in the subgroups of patients with >3 relapses in the two years prior to study entry and >2 new Gd+ lesions at Month 0. Conclusions: There was a lower proportion of subjects with an on-study relapse in natalizumab- treated patients, particularly in those with a more active disease at study entry. Larger ongoing phase III studies will allow more definitive investigation of these preliminary subgroup findings. [ABSTRACT FROM AUTHOR]

Published
2005
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50. Eight-year immunogenicity and safety of interferon beta-1a-Avonex® treatment in patients with multiple sclerosis.

Author

Herndon, Robert M, Rudick, Richard A, Munschauer III, Frederick E, Mass, Michele K, Salazar, Andres M, Coats, Michael E, Labutta, Robert, Richert, John R, Cohan, Stanley L, Genain, Claude, Goodkin, Donald, Toal, Martin, and Riester, Katherine

Subjects
IMMUNOGLOBULINS, ENZYME-linked immunosorbent assay, BLOOD plasma, ANTINEOPLASTIC agents, ANTIVIRAL agents, MEDICAL research
Abstract

An open-label extension study of the phase III trial of intramuscular interferon beta-1a (IFN β-1a-Avonex) was conducted to evaluate the immunogenicity and safety of IFN β-1a-Avonex over six years in patients with relapsing multiple sclerosis (MS). Patients who participated in the pivotal phase III study were offered enrolment; entry was also open to patients who had not participated. All patients received IFN β-1a-Avonex 30 μg intramuscularly once weekly for six years, for a treatment duration of up to eight years in patients who received IFN β-1a-Avonex in the phase III trial. Serum levels of IFN b antibodies were measured every six months using a screening enzyme-linked immunosorbent assay (ELISA) followed by an antiviral cytopathic effect assay to detect neutralizing antibodies (NAbs) in serum samples positive on ELISA. The incidence of adverse events and laboratory test results assessed safety. Of 382 total patients, 218 had participated in the phase III study (103 placebo, 115 IFNβ-1a-Avonex) and 164 had not participated; 24 of the 164 were IFNβ-naïve. At baseline, 281 patients were negative for IFNβ antibodies (NAb -). NAbs (titre ≥20) developed at any time over six years in 5% of these patients. Of 140 patients who had been on IFNβ-1b-Betaseron, 49 were positive for NAbs (NAb +) at baseline; 11 of 115 who had been on IFNβ-1a- Avonex were NAb + at baseline. Thirty-nine of 49 patients who had been on Betaseron and were NAb + had titres <100; 36 of these 39 seroconverted to NAb - while on IFNβ-1a-Avonex, with a median time of approximately six months. Ten patients who had been on Betaseron had NAb titres ≥100; five remained NAb + during six years on IFNβ-1a-Avonex and five seroconverted to NAb -, but only after at least two years. Five patients who had been on IFNβ-1a-Avonex during the clinical trial were NAb -, with titres <100 at baseline; four seroconverted to NAb -, with a median time of two to three years. Six patients who had been on IFNβ-1a-Avonex had NAb titres ≥100; five of these remained NAb + at six years. No patient with a NAb titre > 1000 seroconverted to NAb -, whether initially treated with IFNβ-1a-Avonex or -Betaseron. Adverse events were similar to those observed in the pivotal phase III trial. Results from this trial indicated that IFNβ-1a-Avonex was associated with a low incidence of NAbs and was well tolerated for up to eight years. Further, the results indicate that persistence of NAbs is dependent on titre and IFNβ product. [ABSTRACT FROM AUTHOR]

Published
2005
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