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1. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

Author

Allanore, Y., Khanna, D., Smith, V., Aringer, M., Hoffmann-Vold, A.M., Kuwana, M., Merkel, P.A., Stock, C., Vonk, M.C., Sambevski, S., Denton, C.P., Allanore, Y., Khanna, D., Smith, V., Aringer, M., Hoffmann-Vold, A.M., Kuwana, M., Merkel, P.A., Stock, C., Vonk, M.C., Sambevski, S., and Denton, C.P.

Abstract

Contains fulltext : 305344.pdf (Publisher’s version ) (Open Access), OBJECTIVES: To investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc). METHODS: In the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib. RESULTS: Among 277 patients with lcSSc treated in the SENSCIS trial, the rate (s.e.) of decline in forced vital capacity (FVC; ml/year) over 52 weeks was -74.5 (19.2) in the placebo group and -49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI -28.9, 79.6]). Among 249 patients with data at week 52, mean (s.e.) change in FVC at week 52 was -86.4 (21.1) ml in the placebo group and -39.1 (22.2) ml in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (s.e.) change in FVC from baseline to week 52 of SENSCIS-ON was -41.5 (24.0) ml in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and -45.1 (19.1) ml in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON. CONCLUSION: Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD. TRIAL REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov), NCT02597933 and NCT03313180.

Published
2024

6. 2021 DORIS definition of remission in SLE: Final recommendations from an international task force.

Author

van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., Aranow C., van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., and Aranow C.

Abstract

Objective To achieve consensus on a definition of remission in SLE (DORIS). Background Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. Methods Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. Results Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. Conclusion The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.Copyright © 2021 BMJ Publishing Group. All rights reserved.

Published
2022

7. What are the topics you care about making trials in lupus more effective? Results of an Open Space meeting of international lupus experts.

Author

Mucke J., Alarcon-Riquelme M., Andersen J., Aringer M., Bombardieri S., Brinks R., Cervera R., Chehab G., Cornet A., Costedoat-Chalumeau N., Czirjak L., Doria A., Fischer-Betz R., Furie R.A., Gatto M., Houssiau F.A., Ines L., Liang M.H., Morand E., Mosca M., Pego-Reigosa J.M., Rua-Figueroa I., Ruiz-Irastorza G., Terrier B., Voss A., Schneider M., Mucke J., Alarcon-Riquelme M., Andersen J., Aringer M., Bombardieri S., Brinks R., Cervera R., Chehab G., Cornet A., Costedoat-Chalumeau N., Czirjak L., Doria A., Fischer-Betz R., Furie R.A., Gatto M., Houssiau F.A., Ines L., Liang M.H., Morand E., Mosca M., Pego-Reigosa J.M., Rua-Figueroa I., Ruiz-Irastorza G., Terrier B., Voss A., and Schneider M.

Abstract

Despite promising candidates for new therapeutic options in the treatment of systemic lupus erythematosus (SLE), many clinical trials have failed in the past few years. The disappointing results have been at least partly be attributed to trial designs. With the aim of stimulating new developments in SLE trial design, an international open space meeting was held on occasion of the European Lupus Meeting 2018 in Duesseldorf, Germany about 'What are the topics you care about for making trials in lupus more effective?'. The Open Space is a participant-driven technology, where the discussion topics and schedule are selected during the meeting by all participants and discussion rounds are led by the people attending encouraging active contributions. Eleven topics were selected for further discussion, of which 6 were voted to be more intensively discussed in two consecutive rounds. Major topics were the optimal handling of glucocorticoids in clinical trials, the improvement of outcome measures, reducing or controlling the placebo response and the identification of biomarkers and stratification parameters. Further, the importance of local and international networks was emphasised. By networking, collaborations are facilitated, patient recruitment is more efficient and treatment can be harmonised thus lead to more successful SLE trials. Further discussions are needed to substantiate the results and develop new trial designs. Copyright © 2020 American Society of Mechanical Engineers (ASME). All rights reserved.

Published
2021

8. 2021 DORIS definition of remission in SLE: Final recommendations from an international task force.

Author

van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., Aranow C., van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., and Aranow C.

Abstract

Objective To achieve consensus on a definition of remission in SLE (DORIS). Background Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. Methods Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. Results Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. Conclusion The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.Copyright © 2021 BMJ Publishing Group. All rights reserved.

Published
2021

9. What are the topics you care about making trials in lupus more effective? Results of an Open Space meeting of international lupus experts.

Author

Mucke J., Alarcon-Riquelme M., Andersen J., Aringer M., Bombardieri S., Brinks R., Cervera R., Chehab G., Cornet A., Costedoat-Chalumeau N., Czirjak L., Doria A., Fischer-Betz R., Furie R.A., Gatto M., Houssiau F.A., Ines L., Liang M.H., Morand E., Mosca M., Pego-Reigosa J.M., Rua-Figueroa I., Ruiz-Irastorza G., Terrier B., Voss A., Schneider M., Mucke J., Alarcon-Riquelme M., Andersen J., Aringer M., Bombardieri S., Brinks R., Cervera R., Chehab G., Cornet A., Costedoat-Chalumeau N., Czirjak L., Doria A., Fischer-Betz R., Furie R.A., Gatto M., Houssiau F.A., Ines L., Liang M.H., Morand E., Mosca M., Pego-Reigosa J.M., Rua-Figueroa I., Ruiz-Irastorza G., Terrier B., Voss A., and Schneider M.

Abstract

Despite promising candidates for new therapeutic options in the treatment of systemic lupus erythematosus (SLE), many clinical trials have failed in the past few years. The disappointing results have been at least partly be attributed to trial designs. With the aim of stimulating new developments in SLE trial design, an international open space meeting was held on occasion of the European Lupus Meeting 2018 in Duesseldorf, Germany about 'What are the topics you care about for making trials in lupus more effective?'. The Open Space is a participant-driven technology, where the discussion topics and schedule are selected during the meeting by all participants and discussion rounds are led by the people attending encouraging active contributions. Eleven topics were selected for further discussion, of which 6 were voted to be more intensively discussed in two consecutive rounds. Major topics were the optimal handling of glucocorticoids in clinical trials, the improvement of outcome measures, reducing or controlling the placebo response and the identification of biomarkers and stratification parameters. Further, the importance of local and international networks was emphasised. By networking, collaborations are facilitated, patient recruitment is more efficient and treatment can be harmonised thus lead to more successful SLE trials. Further discussions are needed to substantiate the results and develop new trial designs. Copyright © 2020 American Society of Mechanical Engineers (ASME). All rights reserved.

Published
2021

10. 2021 DORIS definition of remission in SLE: Final recommendations from an international task force.

Author

van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., Aranow C., van Vollenhoven R.F., Bertsias G., Doria A., Isenberg D., Morand E., Petri M.A., Pons-Estel B.A., Rahman A., Ugarte-Gil M.F., Voskuyl A., Arnaud L., Bruce I.N., Cervera R., Costedoat-Chalumeau N., Gordon C., Houssiau F.A., Mosca M., Schneider M., Ward M.M., Alarcon G., Aringer M., Askenase A., Bae S.-C., Bootsma H., Boumpas D.T., Brunner H., Clarke A.E., Coney C., Czirjak L., Dorner T., Faria R., Fischer R., Fritsch-Stork R., Inanc M., Jacobsen S., Jayne D., Kuhn A., van Leeuw B., Limper M., Mariette X., Navarra S., Nikpour M., Olesinska M.H., Pons-Estel G., Romero-Diaz J., Rubio B., Schoenfeld Y., Bonfa E., Smolen J., Teng Y.K.O., Tincani A., Tsang-A-Sjoe M., Vasconcelos C., Voss A., Werth V.P., Zakharhova E., and Aranow C.

Abstract

Objective To achieve consensus on a definition of remission in SLE (DORIS). Background Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. Methods Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. Results Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. Conclusion The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.Copyright © 2021 BMJ Publishing Group. All rights reserved.

Published
2021

12. 2021 DORIS definition of remission in SLE: final recommendations from an international task force

Author

van Vollenhoven, RF, Bertsias, G, Doria, A, Isenberg, D, Morand, E, Petri, MA, Pons-Estel, BA, Rahman, A, Ugarte-Gil, MF, Voskuyl, A, Arnaud, L, Bruce, IN, Cervera, R, Costedoat-Chalumeau, N, Gordon, C, Houssiau, FA, Mosca, M, Schneider, M, Ward, MM, Alarcon, G, Aringer, M, Askenase, A, Bae, S-C, Bootsma, H, Boumpas, DT, Brunner, H, Clarke, AE, Coney, C, Czirjak, L, Doerner, T, Faria, R, Fischer, R, Fritsch-Stork, R, Inanc, M, Jacobsen, S, Jayne, D, Kuhn, A, van Leeuw, B, Limper, M, Mariette, X, Navarra, S, Nikpour, M, Olesinska, MH, Pons-Estel, G, Romero-Diaz, J, Rubio, B, Schoenfeld, Y, Bonfa, E, Smolen, J, Teng, YKO, Tincani, A, Tsang-A-Sjoe, M, Vasconcelos, C, Voss, A, Werth, VP, Zakharhova, E, Aranow, C, van Vollenhoven, RF, Bertsias, G, Doria, A, Isenberg, D, Morand, E, Petri, MA, Pons-Estel, BA, Rahman, A, Ugarte-Gil, MF, Voskuyl, A, Arnaud, L, Bruce, IN, Cervera, R, Costedoat-Chalumeau, N, Gordon, C, Houssiau, FA, Mosca, M, Schneider, M, Ward, MM, Alarcon, G, Aringer, M, Askenase, A, Bae, S-C, Bootsma, H, Boumpas, DT, Brunner, H, Clarke, AE, Coney, C, Czirjak, L, Doerner, T, Faria, R, Fischer, R, Fritsch-Stork, R, Inanc, M, Jacobsen, S, Jayne, D, Kuhn, A, van Leeuw, B, Limper, M, Mariette, X, Navarra, S, Nikpour, M, Olesinska, MH, Pons-Estel, G, Romero-Diaz, J, Rubio, B, Schoenfeld, Y, Bonfa, E, Smolen, J, Teng, YKO, Tincani, A, Tsang-A-Sjoe, M, Vasconcelos, C, Voss, A, Werth, VP, Zakharhova, E, and Aranow, C

Abstract

OBJECTIVE: To achieve consensus on a definition of remission in SLE (DORIS). BACKGROUND: Remission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation. METHODS: Several systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on. RESULTS: Based on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. CONCLUSION: The 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.

Published
2021

14. Potential benefit of convalescent plasma transfusions in immunocompromised patients with COVID-19

Author

Rodionov, R. N., Biener, A., Spieth, P., Achleitner, M., Holig, K., Aringer, M., Mingrone, Geltrude, Corman, V. M., Drosten, C., Bornstein, S. R., Tonn, T., Kolditz, M., Mingrone G. (ORCID:0000-0003-2021-528X), Rodionov, R. N., Biener, A., Spieth, P., Achleitner, M., Holig, K., Aringer, M., Mingrone, Geltrude, Corman, V. M., Drosten, C., Bornstein, S. R., Tonn, T., Kolditz, M., and Mingrone G. (ORCID:0000-0003-2021-528X)

Abstract

N/A

Published
2021

15. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update

Author

Smolen, J.S., Landewe, R.B., Bijlsma, J.W., Burmester, G.R., Dougados, M., Kerschbaumer, A., McInnes, I.B., Sepriano, A., Vollenhoven, R.F. van, Wit, M. de, Aletaha, D., Aringer, M., Askling, J., Balsa, A., Boers, Maarten, Broeder, A.A. den, Buch, M.H., Buttgereit, F., Caporali, R., Cardiel, M.H., Cock, D. De, Codreanu, C., Cutolo, M., Edwards, C.J., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gossec, L., Gottenberg, J.E., Hetland, M.L., Huizinga, T.W.J., Koloumas, M., Li, Z, Mariette, X., Muller-Ladner, U., Mysler, E.F., Silva, J.A. da, Poor, G., Pope, J.E., Rubbert-Roth, A., Ruyssen-Witrand, A., Saag, K.G., Strangfeld, A., Takeuchi, T., Voshaar, M., Westhovens, R., Heijde, D. van der, Smolen, J.S., Landewe, R.B., Bijlsma, J.W., Burmester, G.R., Dougados, M., Kerschbaumer, A., McInnes, I.B., Sepriano, A., Vollenhoven, R.F. van, Wit, M. de, Aletaha, D., Aringer, M., Askling, J., Balsa, A., Boers, Maarten, Broeder, A.A. den, Buch, M.H., Buttgereit, F., Caporali, R., Cardiel, M.H., Cock, D. De, Codreanu, C., Cutolo, M., Edwards, C.J., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gossec, L., Gottenberg, J.E., Hetland, M.L., Huizinga, T.W.J., Koloumas, M., Li, Z, Mariette, X., Muller-Ladner, U., Mysler, E.F., Silva, J.A. da, Poor, G., Pope, J.E., Rubbert-Roth, A., Ruyssen-Witrand, A., Saag, K.G., Strangfeld, A., Takeuchi, T., Voshaar, M., Westhovens, R., and Heijde, D. van der

Abstract

Contains fulltext : 220900.pdf (Publisher’s version ) (Closed access), OBJECTIVES: To provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field. METHODS: An international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items. RESULTS: The task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high.

Published
2020

18. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update

Author

Smolen, J.S., Landewe, R.B., Bijlsma, J.W., Burmester, G.R., Dougados, M., Kerschbaumer, A., McInnes, I.B., Sepriano, A., Vollenhoven, R.F. van, Wit, M. de, Aletaha, D., Aringer, M., Askling, J., Balsa, A., Boers, Maarten, Broeder, A.A. den, Buch, M.H., Buttgereit, F., Caporali, R., Cardiel, M.H., Cock, D. De, Codreanu, C., Cutolo, M., Edwards, C.J., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gossec, L., Gottenberg, J.E., Hetland, M.L., Huizinga, T.W.J., Koloumas, M., Li, Z, Mariette, X., Muller-Ladner, U., Mysler, E.F., Silva, J.A. da, Poor, G., Pope, J.E., Rubbert-Roth, A., Ruyssen-Witrand, A., Saag, K.G., Strangfeld, A., Takeuchi, T., Voshaar, M., Westhovens, R., Heijde, D. van der, Smolen, J.S., Landewe, R.B., Bijlsma, J.W., Burmester, G.R., Dougados, M., Kerschbaumer, A., McInnes, I.B., Sepriano, A., Vollenhoven, R.F. van, Wit, M. de, Aletaha, D., Aringer, M., Askling, J., Balsa, A., Boers, Maarten, Broeder, A.A. den, Buch, M.H., Buttgereit, F., Caporali, R., Cardiel, M.H., Cock, D. De, Codreanu, C., Cutolo, M., Edwards, C.J., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gossec, L., Gottenberg, J.E., Hetland, M.L., Huizinga, T.W.J., Koloumas, M., Li, Z, Mariette, X., Muller-Ladner, U., Mysler, E.F., Silva, J.A. da, Poor, G., Pope, J.E., Rubbert-Roth, A., Ruyssen-Witrand, A., Saag, K.G., Strangfeld, A., Takeuchi, T., Voshaar, M., Westhovens, R., and Heijde, D. van der

Abstract

Contains fulltext : 220900.pdf (Publisher’s version ) (Closed access), OBJECTIVES: To provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field. METHODS: An international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items. RESULTS: The task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high.

Published
2020

19. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update

Author

Smolen, J.S., Landewe, R.B., Bijlsma, J.W., Burmester, G.R., Dougados, M., Kerschbaumer, A., McInnes, I.B., Sepriano, A., Vollenhoven, R.F. van, Wit, M. de, Aletaha, D., Aringer, M., Askling, J., Balsa, A., Boers, Maarten, Broeder, A.A. den, Buch, M.H., Buttgereit, F., Caporali, R., Cardiel, M.H., Cock, D. De, Codreanu, C., Cutolo, M., Edwards, C.J., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gossec, L., Gottenberg, J.E., Hetland, M.L., Huizinga, T.W.J., Koloumas, M., Li, Z, Mariette, X., Muller-Ladner, U., Mysler, E.F., Silva, J.A. da, Poor, G., Pope, J.E., Rubbert-Roth, A., Ruyssen-Witrand, A., Saag, K.G., Strangfeld, A., Takeuchi, T., Voshaar, M., Westhovens, R., Heijde, D. van der, Smolen, J.S., Landewe, R.B., Bijlsma, J.W., Burmester, G.R., Dougados, M., Kerschbaumer, A., McInnes, I.B., Sepriano, A., Vollenhoven, R.F. van, Wit, M. de, Aletaha, D., Aringer, M., Askling, J., Balsa, A., Boers, Maarten, Broeder, A.A. den, Buch, M.H., Buttgereit, F., Caporali, R., Cardiel, M.H., Cock, D. De, Codreanu, C., Cutolo, M., Edwards, C.J., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gossec, L., Gottenberg, J.E., Hetland, M.L., Huizinga, T.W.J., Koloumas, M., Li, Z, Mariette, X., Muller-Ladner, U., Mysler, E.F., Silva, J.A. da, Poor, G., Pope, J.E., Rubbert-Roth, A., Ruyssen-Witrand, A., Saag, K.G., Strangfeld, A., Takeuchi, T., Voshaar, M., Westhovens, R., and Heijde, D. van der

Abstract

Contains fulltext : 220900.pdf (Publisher’s version ) (Closed access), OBJECTIVES: To provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field. METHODS: An international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items. RESULTS: The task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high.

Published
2020

26. The comparative responsiveness of Hospital Universitario Princesa Index and other composite indices for assessing rheumatoid arthritis activity

Author

Gonzalez-Alvaro, Isidoro, Castrejon, Isabel, Carmona, Loreto, Dougados, M., Huizinga, T., Abu Shakra, M., Alberts, A., Alperi Lopez, M., Amital, H., Aringer, M., Aslanidis, S., Berenbaum, F., Bijlsma, H., Blanco Garcia, F. J., Bliddal, H., Borofsky, M., Brocq, O., Buldakov, S., Cantini, F., Carreno Perez, L., Chahade, W., Ciconelli, R., Codreanu, C., Dahlqvist, S. R., Damjanov, N., Diamantopoulos, A., Dimdina, L., Dimic, A., Dorokhov, A., Dubikov, A., Fadienko, G., Fano, N., Ferreira, G., Gabrielli, A., Gaffney, K., Gaudin, P., Gerlag, D. M., Gerli, R., Goncalves, C. R., Hansen, M. S., Hanvivadhanakul, P., Hoili, C., Hou, A., Hunter, J., Ilic, T., Ionescu, R., Kaine, J., Kakurina, N., Kamalova, R., Kelly, T., Knyazeva, L., Krumina, L., Kurthen, R., Lagrone, R. P., Lapadula, G., Lavrentjevs, V, Lawson, J. G., Lazic, Z., Lejnieks, A., Levy, Y., Lexberg, A., Mader, R., Mariette, X., Markovits, D., Mola, Martin E., Maugars, Y., Guarch, Maymo J., Mazurov, V., I, Mikkelsen, K., Vergles, Morovic J., Nabizadeh, S., Nanagara, R., Nasonov, E. L., Sarabia, Navarro F., Neumann, T., Novak, S., Olech, E., Oza, M., Paran, D., Parsik, E., Pegram, S., Suarez, Pombo M., Popova, T., Puechal, X., Raja, N., Ridley, D., Rosner, I, Rubbert-Roth, A., Rudin, A., Saraux, A., Saulite-Kandevica, D., Settas, L., Sfikakis, P., Sheeran, T., Sizikov, A., Stamenkovic, D., Stefanovic, D., Stolow, J. B., Tan, A. L., Tebib, J., Tishler, M., Tony, H. P., Troum, O. M., Uaratanawong, S., Ucar Angulo, E., Valenzuela, G., van der Laken, K., Van Laar, J., van Riel, P. L. C. M., Vasilopoulos, D., Veldi, T., Vinogradova, I, Vosse, D., Wassenberg, S., Weidmann, C., Weitz, M., Wollenhaupt, J., Xavier, R., Yakupova, S., Zagar, I, Zavgorodnaja, T., Zemerova, E., Zisman, D., Zonova, E., Camona, Loreto, Abasolo Alcazar, L., Alegre de Miguel, C., Andreu Sanchez, J. L., Aragon Diez, A., Balsa Criado, A., Batlle Gualda, E., Belmonte Serrano, M. A., Beltran Audera, J., Beltran Fabregat, J., Bonilla Hernan, G., Caro Fernandez, N., Casado, E., Cebrian Mendez, L., Corteguera Coro, M., Cuadra Diaz, J. L., Cuesta, E., Fiter Areste, J., Freire Gonzalez, M., Galindo Izquierdo, M., Garcia Meijide, J. A., Garcia Gomez, M. C., Gimenez Ubeda, E., Gomez Centeno, E., Gomez Vaquero, C., Gonzalez Fernandez, M. J., Gonzalez Gomez, M. L., Gonzalez Hernandez, T., Gonzalez-Alvaro, I, Gonzalez-Montagut Gomez, C., Grandal Delgado, Y., Gratacos Masmitja, J., Hernandez del Rio, A., Instxaurbe, A. R., Irigoyen Oyarzabal, M., V, Jimenez Palop, M., Juan Mas, A., Judez Navarro, E., Larrosa Padro, M., Lopez Longo, F. J., Loza Santamaria, E., Maese Manzano, J., Manero Ruiz, F. J., Mateo Bernardo, I, Mayordomo Gonzalez, L., Mazzucheli, R., Medrano San Idelfonso, M., Naranjo Hernandez, A., Pecondon Espanol, A., Peiro Callizo, E., Quiros Donate, J., Ramos Lopez, P., Rivera Redondo, J., Rodriguez Gomez, M., Rodriguez Lopez, M., Rosello Pardo, R., Sampedro Alvarez, J., Sanmarti Sala, R., Rey Rey, Santos J., Tena Marsa, X., Tenorio Martin, M., Torres Martin, M. C., Urena Garnica, I, Valdazo de Diego, J. P., Valls, M., Villaverde Garcia, V., Zarco Montejo, P., Zubieta Tabernero, J., Balsa, Alejandro, Sanmarti, Raimon, Cabezas, J. A., Cantalejo, M., Chamizo, E., Ciruelo, E., Corrales, A., Cruz, A., Diaz, C., Fiter, J., Freire, M. M., Galindo, M., Garcia de Vicuna, M. R., Gelman, S. M., Gonzalez Crespo, R., Gonzalez Fernandez, C., Gracia, A., Granados, J., Guzman, M. A., Irigoyen, M., V, Juan, A., Juanola, X., Laiz, A., Manero, F. J., Martinez, A., Martinez, F., Mata, C., Maymo, J., Navarro, F. J., Peiro, E., Perez, F., Perez, G., Perez, M., Pujol, M., Quiros, J., Ribas, B., Riera, M., Rivera, J., Rodriguez, J. M., Rosello, R., Tenorio, M., Toyos, F. J., Gonzalez-Alvaro, Isidoro, Castrejon, Isabel, Carmona, Loreto, Dougados, M., Huizinga, T., Abu Shakra, M., Alberts, A., Alperi Lopez, M., Amital, H., Aringer, M., Aslanidis, S., Berenbaum, F., Bijlsma, H., Blanco Garcia, F. J., Bliddal, H., Borofsky, M., Brocq, O., Buldakov, S., Cantini, F., Carreno Perez, L., Chahade, W., Ciconelli, R., Codreanu, C., Dahlqvist, S. R., Damjanov, N., Diamantopoulos, A., Dimdina, L., Dimic, A., Dorokhov, A., Dubikov, A., Fadienko, G., Fano, N., Ferreira, G., Gabrielli, A., Gaffney, K., Gaudin, P., Gerlag, D. M., Gerli, R., Goncalves, C. R., Hansen, M. S., Hanvivadhanakul, P., Hoili, C., Hou, A., Hunter, J., Ilic, T., Ionescu, R., Kaine, J., Kakurina, N., Kamalova, R., Kelly, T., Knyazeva, L., Krumina, L., Kurthen, R., Lagrone, R. P., Lapadula, G., Lavrentjevs, V, Lawson, J. G., Lazic, Z., Lejnieks, A., Levy, Y., Lexberg, A., Mader, R., Mariette, X., Markovits, D., Mola, Martin E., Maugars, Y., Guarch, Maymo J., Mazurov, V., I, Mikkelsen, K., Vergles, Morovic J., Nabizadeh, S., Nanagara, R., Nasonov, E. L., Sarabia, Navarro F., Neumann, T., Novak, S., Olech, E., Oza, M., Paran, D., Parsik, E., Pegram, S., Suarez, Pombo M., Popova, T., Puechal, X., Raja, N., Ridley, D., Rosner, I, Rubbert-Roth, A., Rudin, A., Saraux, A., Saulite-Kandevica, D., Settas, L., Sfikakis, P., Sheeran, T., Sizikov, A., Stamenkovic, D., Stefanovic, D., Stolow, J. B., Tan, A. L., Tebib, J., Tishler, M., Tony, H. P., Troum, O. M., Uaratanawong, S., Ucar Angulo, E., Valenzuela, G., van der Laken, K., Van Laar, J., van Riel, P. L. C. M., Vasilopoulos, D., Veldi, T., Vinogradova, I, Vosse, D., Wassenberg, S., Weidmann, C., Weitz, M., Wollenhaupt, J., Xavier, R., Yakupova, S., Zagar, I, Zavgorodnaja, T., Zemerova, E., Zisman, D., Zonova, E., Camona, Loreto, Abasolo Alcazar, L., Alegre de Miguel, C., Andreu Sanchez, J. L., Aragon Diez, A., Balsa Criado, A., Batlle Gualda, E., Belmonte Serrano, M. A., Beltran Audera, J., Beltran Fabregat, J., Bonilla Hernan, G., Caro Fernandez, N., Casado, E., Cebrian Mendez, L., Corteguera Coro, M., Cuadra Diaz, J. L., Cuesta, E., Fiter Areste, J., Freire Gonzalez, M., Galindo Izquierdo, M., Garcia Meijide, J. A., Garcia Gomez, M. C., Gimenez Ubeda, E., Gomez Centeno, E., Gomez Vaquero, C., Gonzalez Fernandez, M. J., Gonzalez Gomez, M. L., Gonzalez Hernandez, T., Gonzalez-Alvaro, I, Gonzalez-Montagut Gomez, C., Grandal Delgado, Y., Gratacos Masmitja, J., Hernandez del Rio, A., Instxaurbe, A. R., Irigoyen Oyarzabal, M., V, Jimenez Palop, M., Juan Mas, A., Judez Navarro, E., Larrosa Padro, M., Lopez Longo, F. J., Loza Santamaria, E., Maese Manzano, J., Manero Ruiz, F. J., Mateo Bernardo, I, Mayordomo Gonzalez, L., Mazzucheli, R., Medrano San Idelfonso, M., Naranjo Hernandez, A., Pecondon Espanol, A., Peiro Callizo, E., Quiros Donate, J., Ramos Lopez, P., Rivera Redondo, J., Rodriguez Gomez, M., Rodriguez Lopez, M., Rosello Pardo, R., Sampedro Alvarez, J., Sanmarti Sala, R., Rey Rey, Santos J., Tena Marsa, X., Tenorio Martin, M., Torres Martin, M. C., Urena Garnica, I, Valdazo de Diego, J. P., Valls, M., Villaverde Garcia, V., Zarco Montejo, P., Zubieta Tabernero, J., Balsa, Alejandro, Sanmarti, Raimon, Cabezas, J. A., Cantalejo, M., Chamizo, E., Ciruelo, E., Corrales, A., Cruz, A., Diaz, C., Fiter, J., Freire, M. M., Galindo, M., Garcia de Vicuna, M. R., Gelman, S. M., Gonzalez Crespo, R., Gonzalez Fernandez, C., Gracia, A., Granados, J., Guzman, M. A., Irigoyen, M., V, Juan, A., Juanola, X., Laiz, A., Manero, F. J., Martinez, A., Martinez, F., Mata, C., Maymo, J., Navarro, F. J., Peiro, E., Perez, F., Perez, G., Perez, M., Pujol, M., Quiros, J., Ribas, B., Riera, M., Rivera, J., Rodriguez, J. M., Rosello, R., Tenorio, M., and Toyos, F. J.

Abstract

Objective To evaluate the responsiveness in terms of correlation of the Hospital Universitario La Princesa Index (HUPI) comparatively to the traditional composite indices used to assess disease activity in rheumatoid arthritis (RA), and to compare the performance of HUPI-based response criteria with that of the EULAR response criteria. Methods Secondary data analysis from the following studies: ACT-RAY (clinical trial), PROAR (early RA cohort) and EMECAR (pre-biologic era long term RA cohort). Responsiveness was evaluated by: 1) comparing change from baseline (Delta) of HUPI with Delta in other scores by calculating correlation coefficients; 2) calculating standardised effect sizes. The accuracy of response by HUPI and by EULAR criteria was analyzed using linear regressions in which the dependent variable was change in global assessment by physician (Delta GDA-Phy). Results Delta HUPI correlation with change in all other indices ranged from 0.387 to 0.791); HUPI's standardized effect size was larger than those from the other indices in each database used. In ACT-RAY, depending on visit, between 65 and 80% of patients were equally classified by HUPI and EULAR response criteria. However, HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits. HUPI response criteria showed a slightly higher accuracy than EULAR response criteria when using Delta GDA-Phy as gold standard. Conclusion HUPI shows good responsiveness in terms of correlation in each studied scenario (clinical trial, early RA cohort, and established RA cohort). Response criteria by HUPI seem more stringent than EULAR's.

Published
2019

28. Einfluss der Kombinationstherapie von Rituximab und Lefluonmid auf Patient-Reported Outcomes und Funktion in Patienten mit Rheumatoider Arthritis: Ergebnisse einer multizentrischen, randomisierten, Placebo-kontrollierten Investigator initiierten Studie (AMARA-Study)

Author

Köhm, M, Rossmanith, T, Dauth, S, Alten, RHE, Aringer, M, Backhaus, M, Burmester, GR, Feist, E, Kellner, H, Krüger, K, Müller-Ladner, U, Rubbert-Roth, A, Tony, HP, Wassenberg, S, Burkhardt, HL, Behrens, F, Köhm, M, Rossmanith, T, Dauth, S, Alten, RHE, Aringer, M, Backhaus, M, Burmester, GR, Feist, E, Kellner, H, Krüger, K, Müller-Ladner, U, Rubbert-Roth, A, Tony, HP, Wassenberg, S, Burkhardt, HL, and Behrens, F

Published
2019

29. Verbesserung des HbA1c bei RA Patienten mit Diabetes unter Tocilizumab

Author

Specker, C, Alberding, A, Aringer, M, Burmester, GR, Flacke, JP, Hofmann, MW, Kästner, P, Kellner, H, Moosig, F, Sieburg, M, Tony, HP, Fliedner, G, Specker, C, Alberding, A, Aringer, M, Burmester, GR, Flacke, JP, Hofmann, MW, Kästner, P, Kellner, H, Moosig, F, Sieburg, M, Tony, HP, and Fliedner, G

Published
2019

32. Verbesserung des HbA1c bei RA Patienten mit Diabetes unter Tocilizumab

Author

Specker, C, Alberding, A, Aringer, M, Burmester, GR, Flacke, JP, Hofmann, MW, Kästner, P, Kellner, H, Moosig, F, Sieburg, M, Tony, HP, Fliedner, G, Specker, C, Alberding, A, Aringer, M, Burmester, GR, Flacke, JP, Hofmann, MW, Kästner, P, Kellner, H, Moosig, F, Sieburg, M, Tony, HP, and Fliedner, G

Published
2019

35. Einfluss der Kombinationstherapie von Rituximab und Lefluonmid auf Patient-Reported Outcomes und Funktion in Patienten mit Rheumatoider Arthritis: Ergebnisse einer multizentrischen, randomisierten, Placebo-kontrollierten Investigator initiierten Studie (AMARA-Study)

Author

Köhm, M, Rossmanith, T, Dauth, S, Alten, RHE, Aringer, M, Backhaus, M, Burmester, GR, Feist, E, Kellner, H, Krüger, K, Müller-Ladner, U, Rubbert-Roth, A, Tony, HP, Wassenberg, S, Burkhardt, HL, Behrens, F, Köhm, M, Rossmanith, T, Dauth, S, Alten, RHE, Aringer, M, Backhaus, M, Burmester, GR, Feist, E, Kellner, H, Krüger, K, Müller-Ladner, U, Rubbert-Roth, A, Tony, HP, Wassenberg, S, Burkhardt, HL, and Behrens, F

Published
2019

36. The comparative responsiveness of Hospital Universitario Princesa Index and other composite indices for assessing rheumatoid arthritis activity

Author

Gonzalez-Alvaro, Isidoro, Castrejon, Isabel, Carmona, Loreto, Dougados, M., Huizinga, T., Abu Shakra, M., Alberts, A., Alperi Lopez, M., Amital, H., Aringer, M., Aslanidis, S., Berenbaum, F., Bijlsma, H., Blanco Garcia, F. J., Bliddal, H., Borofsky, M., Brocq, O., Buldakov, S., Cantini, F., Carreno Perez, L., Chahade, W., Ciconelli, R., Codreanu, C., Dahlqvist, S. R., Damjanov, N., Diamantopoulos, A., Dimdina, L., Dimic, A., Dorokhov, A., Dubikov, A., Fadienko, G., Fano, N., Ferreira, G., Gabrielli, A., Gaffney, K., Gaudin, P., Gerlag, D. M., Gerli, R., Goncalves, C. R., Hansen, M. S., Hanvivadhanakul, P., Hoili, C., Hou, A., Hunter, J., Ilic, T., Ionescu, R., Kaine, J., Kakurina, N., Kamalova, R., Kelly, T., Knyazeva, L., Krumina, L., Kurthen, R., Lagrone, R. P., Lapadula, G., Lavrentjevs, V, Lawson, J. G., Lazic, Z., Lejnieks, A., Levy, Y., Lexberg, A., Mader, R., Mariette, X., Markovits, D., Mola, Martin E., Maugars, Y., Guarch, Maymo J., Mazurov, V., I, Mikkelsen, K., Vergles, Morovic J., Nabizadeh, S., Nanagara, R., Nasonov, E. L., Sarabia, Navarro F., Neumann, T., Novak, S., Olech, E., Oza, M., Paran, D., Parsik, E., Pegram, S., Suarez, Pombo M., Popova, T., Puechal, X., Raja, N., Ridley, D., Rosner, I, Rubbert-Roth, A., Rudin, A., Saraux, A., Saulite-Kandevica, D., Settas, L., Sfikakis, P., Sheeran, T., Sizikov, A., Stamenkovic, D., Stefanovic, D., Stolow, J. B., Tan, A. L., Tebib, J., Tishler, M., Tony, H. P., Troum, O. M., Uaratanawong, S., Ucar Angulo, E., Valenzuela, G., van der Laken, K., Van Laar, J., van Riel, P. L. C. M., Vasilopoulos, D., Veldi, T., Vinogradova, I, Vosse, D., Wassenberg, S., Weidmann, C., Weitz, M., Wollenhaupt, J., Xavier, R., Yakupova, S., Zagar, I, Zavgorodnaja, T., Zemerova, E., Zisman, D., Zonova, E., Camona, Loreto, Abasolo Alcazar, L., Alegre de Miguel, C., Andreu Sanchez, J. L., Aragon Diez, A., Balsa Criado, A., Batlle Gualda, E., Belmonte Serrano, M. A., Beltran Audera, J., Beltran Fabregat, J., Bonilla Hernan, G., Caro Fernandez, N., Casado, E., Cebrian Mendez, L., Corteguera Coro, M., Cuadra Diaz, J. L., Cuesta, E., Fiter Areste, J., Freire Gonzalez, M., Galindo Izquierdo, M., Garcia Meijide, J. A., Garcia Gomez, M. C., Gimenez Ubeda, E., Gomez Centeno, E., Gomez Vaquero, C., Gonzalez Fernandez, M. J., Gonzalez Gomez, M. L., Gonzalez Hernandez, T., Gonzalez-Alvaro, I, Gonzalez-Montagut Gomez, C., Grandal Delgado, Y., Gratacos Masmitja, J., Hernandez del Rio, A., Instxaurbe, A. R., Irigoyen Oyarzabal, M., V, Jimenez Palop, M., Juan Mas, A., Judez Navarro, E., Larrosa Padro, M., Lopez Longo, F. J., Loza Santamaria, E., Maese Manzano, J., Manero Ruiz, F. J., Mateo Bernardo, I, Mayordomo Gonzalez, L., Mazzucheli, R., Medrano San Idelfonso, M., Naranjo Hernandez, A., Pecondon Espanol, A., Peiro Callizo, E., Quiros Donate, J., Ramos Lopez, P., Rivera Redondo, J., Rodriguez Gomez, M., Rodriguez Lopez, M., Rosello Pardo, R., Sampedro Alvarez, J., Sanmarti Sala, R., Rey Rey, Santos J., Tena Marsa, X., Tenorio Martin, M., Torres Martin, M. C., Urena Garnica, I, Valdazo de Diego, J. P., Valls, M., Villaverde Garcia, V., Zarco Montejo, P., Zubieta Tabernero, J., Balsa, Alejandro, Sanmarti, Raimon, Cabezas, J. A., Cantalejo, M., Chamizo, E., Ciruelo, E., Corrales, A., Cruz, A., Diaz, C., Fiter, J., Freire, M. M., Galindo, M., Garcia de Vicuna, M. R., Gelman, S. M., Gonzalez Crespo, R., Gonzalez Fernandez, C., Gracia, A., Granados, J., Guzman, M. A., Irigoyen, M., V, Juan, A., Juanola, X., Laiz, A., Manero, F. J., Martinez, A., Martinez, F., Mata, C., Maymo, J., Navarro, F. J., Peiro, E., Perez, F., Perez, G., Perez, M., Pujol, M., Quiros, J., Ribas, B., Riera, M., Rivera, J., Rodriguez, J. M., Rosello, R., Tenorio, M., Toyos, F. J., Gonzalez-Alvaro, Isidoro, Castrejon, Isabel, Carmona, Loreto, Dougados, M., Huizinga, T., Abu Shakra, M., Alberts, A., Alperi Lopez, M., Amital, H., Aringer, M., Aslanidis, S., Berenbaum, F., Bijlsma, H., Blanco Garcia, F. J., Bliddal, H., Borofsky, M., Brocq, O., Buldakov, S., Cantini, F., Carreno Perez, L., Chahade, W., Ciconelli, R., Codreanu, C., Dahlqvist, S. R., Damjanov, N., Diamantopoulos, A., Dimdina, L., Dimic, A., Dorokhov, A., Dubikov, A., Fadienko, G., Fano, N., Ferreira, G., Gabrielli, A., Gaffney, K., Gaudin, P., Gerlag, D. M., Gerli, R., Goncalves, C. R., Hansen, M. S., Hanvivadhanakul, P., Hoili, C., Hou, A., Hunter, J., Ilic, T., Ionescu, R., Kaine, J., Kakurina, N., Kamalova, R., Kelly, T., Knyazeva, L., Krumina, L., Kurthen, R., Lagrone, R. P., Lapadula, G., Lavrentjevs, V, Lawson, J. G., Lazic, Z., Lejnieks, A., Levy, Y., Lexberg, A., Mader, R., Mariette, X., Markovits, D., Mola, Martin E., Maugars, Y., Guarch, Maymo J., Mazurov, V., I, Mikkelsen, K., Vergles, Morovic J., Nabizadeh, S., Nanagara, R., Nasonov, E. L., Sarabia, Navarro F., Neumann, T., Novak, S., Olech, E., Oza, M., Paran, D., Parsik, E., Pegram, S., Suarez, Pombo M., Popova, T., Puechal, X., Raja, N., Ridley, D., Rosner, I, Rubbert-Roth, A., Rudin, A., Saraux, A., Saulite-Kandevica, D., Settas, L., Sfikakis, P., Sheeran, T., Sizikov, A., Stamenkovic, D., Stefanovic, D., Stolow, J. B., Tan, A. L., Tebib, J., Tishler, M., Tony, H. P., Troum, O. M., Uaratanawong, S., Ucar Angulo, E., Valenzuela, G., van der Laken, K., Van Laar, J., van Riel, P. L. C. M., Vasilopoulos, D., Veldi, T., Vinogradova, I, Vosse, D., Wassenberg, S., Weidmann, C., Weitz, M., Wollenhaupt, J., Xavier, R., Yakupova, S., Zagar, I, Zavgorodnaja, T., Zemerova, E., Zisman, D., Zonova, E., Camona, Loreto, Abasolo Alcazar, L., Alegre de Miguel, C., Andreu Sanchez, J. L., Aragon Diez, A., Balsa Criado, A., Batlle Gualda, E., Belmonte Serrano, M. A., Beltran Audera, J., Beltran Fabregat, J., Bonilla Hernan, G., Caro Fernandez, N., Casado, E., Cebrian Mendez, L., Corteguera Coro, M., Cuadra Diaz, J. L., Cuesta, E., Fiter Areste, J., Freire Gonzalez, M., Galindo Izquierdo, M., Garcia Meijide, J. A., Garcia Gomez, M. C., Gimenez Ubeda, E., Gomez Centeno, E., Gomez Vaquero, C., Gonzalez Fernandez, M. J., Gonzalez Gomez, M. L., Gonzalez Hernandez, T., Gonzalez-Alvaro, I, Gonzalez-Montagut Gomez, C., Grandal Delgado, Y., Gratacos Masmitja, J., Hernandez del Rio, A., Instxaurbe, A. R., Irigoyen Oyarzabal, M., V, Jimenez Palop, M., Juan Mas, A., Judez Navarro, E., Larrosa Padro, M., Lopez Longo, F. J., Loza Santamaria, E., Maese Manzano, J., Manero Ruiz, F. J., Mateo Bernardo, I, Mayordomo Gonzalez, L., Mazzucheli, R., Medrano San Idelfonso, M., Naranjo Hernandez, A., Pecondon Espanol, A., Peiro Callizo, E., Quiros Donate, J., Ramos Lopez, P., Rivera Redondo, J., Rodriguez Gomez, M., Rodriguez Lopez, M., Rosello Pardo, R., Sampedro Alvarez, J., Sanmarti Sala, R., Rey Rey, Santos J., Tena Marsa, X., Tenorio Martin, M., Torres Martin, M. C., Urena Garnica, I, Valdazo de Diego, J. P., Valls, M., Villaverde Garcia, V., Zarco Montejo, P., Zubieta Tabernero, J., Balsa, Alejandro, Sanmarti, Raimon, Cabezas, J. A., Cantalejo, M., Chamizo, E., Ciruelo, E., Corrales, A., Cruz, A., Diaz, C., Fiter, J., Freire, M. M., Galindo, M., Garcia de Vicuna, M. R., Gelman, S. M., Gonzalez Crespo, R., Gonzalez Fernandez, C., Gracia, A., Granados, J., Guzman, M. A., Irigoyen, M., V, Juan, A., Juanola, X., Laiz, A., Manero, F. J., Martinez, A., Martinez, F., Mata, C., Maymo, J., Navarro, F. J., Peiro, E., Perez, F., Perez, G., Perez, M., Pujol, M., Quiros, J., Ribas, B., Riera, M., Rivera, J., Rodriguez, J. M., Rosello, R., Tenorio, M., and Toyos, F. J.

Abstract

Objective To evaluate the responsiveness in terms of correlation of the Hospital Universitario La Princesa Index (HUPI) comparatively to the traditional composite indices used to assess disease activity in rheumatoid arthritis (RA), and to compare the performance of HUPI-based response criteria with that of the EULAR response criteria. Methods Secondary data analysis from the following studies: ACT-RAY (clinical trial), PROAR (early RA cohort) and EMECAR (pre-biologic era long term RA cohort). Responsiveness was evaluated by: 1) comparing change from baseline (Delta) of HUPI with Delta in other scores by calculating correlation coefficients; 2) calculating standardised effect sizes. The accuracy of response by HUPI and by EULAR criteria was analyzed using linear regressions in which the dependent variable was change in global assessment by physician (Delta GDA-Phy). Results Delta HUPI correlation with change in all other indices ranged from 0.387 to 0.791); HUPI's standardized effect size was larger than those from the other indices in each database used. In ACT-RAY, depending on visit, between 65 and 80% of patients were equally classified by HUPI and EULAR response criteria. However, HUPI criteria were slightly more stringent, with higher percentage of patients classified as non-responder, especially at early visits. HUPI response criteria showed a slightly higher accuracy than EULAR response criteria when using Delta GDA-Phy as gold standard. Conclusion HUPI shows good responsiveness in terms of correlation in each studied scenario (clinical trial, early RA cohort, and established RA cohort). Response criteria by HUPI seem more stringent than EULAR's.

Published
2019

37. What have multicentre registries across the world taught us about the disease features of systemic sclerosis?.

Author

Iannone F., Schett G., Distler J.H., Meroni P., Zeni S., Mouthon L., De Keyser F., Smith V., Cantatore F.P., Corrado A., Ullman S., Iversen L., Pozzi M.R., Eyerich K., Hein R., Knott E., Szechinski J., Wiland P., Szmyrka-Kaczmarek M., Sokolik R., Morgiel E., Krummel-Lorenz B., Saar P., Aringer M., Gunther C., Anic B., Baresic M., Mayer M., Radominski S.C., de Souza Muller C., Azevedo V.F., Agachi S., Groppa L., Chiaburu L., Russu E., Zenone T., Stebbings S., Highton J., Stamp L., Chapman P., O'Donnell J., Solanki K., Doube A., Veale D., O'Rourke M., Loyo E., Rosato E., Pisarri S., Tanaseanu C.-M., Popescu M., Dumitrascu A., Tiglea I., Chirieac R., Ancuta C., Furst D.E., Kafaja S., Garcia de la Pena Lefebvre P., Rubio S.R., Exposito M.V., Sibilia J., Chatelus E., Gottenberg J.E., Chifflot H., Litinsky I., Venalis A., Butrimiene I., Venalis P., Rugiene R., Karpec D., Kerzberg E., Montoya F., Cosentino V., Low A.H.L., Teng G., Chan G., Lim A.Y.N., Ng S.C., Kowal-Bielecka O., Proudman S.M., Huq M., Stevens W., Wilson M.E., Sahhar J., Baron M., Hudson M., Allanore Y., Distler O., Bielecka O.K., Matucci-Cerinic M., H.L. Low A., Teng G.G., Law W.G., Santosa A., Nikpour M., Hill C., Lester S., Nash P., Ngian G.-S., Proudman S., Rischmueller M., Roddy J., Strickland G., Thakkar V., Walker J., Zochling J., Pope J., Markland J., Robinson D., Jones N., Khalidi N., Docherty P., Kaminska E., Masetto A., Sutton E., Mathieu J.-P., Ligier S., Grodzicky T., LeClercq S., Thorne C., Gyger G., Smith D., Fortin P.R., Larche M., Abu-Hakima M., Rodriguez-Reyna T.S., Cabral A.R., Fritzler M., Avouac J., Walker U.A., Guiducci S., Riemekasten G., Air P., Hachulla E., Valentini G., Carreira P.E., Cozzi F., Gurman A.B., Braun-Moscovici Y., Damjanov N., Ananieva L.P., Scorza R., Jimenez S., Busquets J., Li M., Muller-Ladner U., Maurer B., Tyndall A., Lapadula G., Becvar R., Sierakowsky S., Cutolo M., Sulli A., Cuomo G., Vettori S., Rednic S., Nicoara I., Vlachoyiannopoulos P., Montecucco C., Caporali R., Novak S., Czirjak L., Varju C., Chizzolini C., Kucharz E.J., Kotulska A., Kopec-Medrek M., Widuchowska M., Rozman B., Mallia C., Coleiro B., Gabrielli A., Farge D., Hij A., Hesselstrand R., Scheja A., Wollheim F., Martinovic D., Govoni M., Lo Monaco A., Hunzelmann N., Pellerito R., Bambara L.M., Caramaschi P., Black C., Denton C., Henes J., Santamaria V.O., Heitmann S., Krasowska D., Seidel M., Oleszowsky M., Burkhardt H., Himsel A., Salvador M.J., Stamenkovic B., Stankovic A., Tikly M., Starovoytova M.N., Engelhart M., Strauss G., Nielsen H., Damgaard K., Szucs G., Mendoza A.Z., de la Puente Buijdos C., Giraldo W.A.S., Midtvedt O., Garen T., Launay D., Valesini G., Riccieri V., Ionescu R.M., Opris D., Groseanu L., Wigley F.M., Mihai C.M., Cornateanu R.S., Ionitescu R., Gherghe A.M., Gorga M., Dobrota R., Bojinca M., Iannone F., Schett G., Distler J.H., Meroni P., Zeni S., Mouthon L., De Keyser F., Smith V., Cantatore F.P., Corrado A., Ullman S., Iversen L., Pozzi M.R., Eyerich K., Hein R., Knott E., Szechinski J., Wiland P., Szmyrka-Kaczmarek M., Sokolik R., Morgiel E., Krummel-Lorenz B., Saar P., Aringer M., Gunther C., Anic B., Baresic M., Mayer M., Radominski S.C., de Souza Muller C., Azevedo V.F., Agachi S., Groppa L., Chiaburu L., Russu E., Zenone T., Stebbings S., Highton J., Stamp L., Chapman P., O'Donnell J., Solanki K., Doube A., Veale D., O'Rourke M., Loyo E., Rosato E., Pisarri S., Tanaseanu C.-M., Popescu M., Dumitrascu A., Tiglea I., Chirieac R., Ancuta C., Furst D.E., Kafaja S., Garcia de la Pena Lefebvre P., Rubio S.R., Exposito M.V., Sibilia J., Chatelus E., Gottenberg J.E., Chifflot H., Litinsky I., Venalis A., Butrimiene I., Venalis P., Rugiene R., Karpec D., Kerzberg E., Montoya F., Cosentino V., Low A.H.L., Teng G., Chan G., Lim A.Y.N., Ng S.C., Kowal-Bielecka O., Proudman S.M., Huq M., Stevens W., Wilson M.E., Sahhar J., Baron M., Hudson M., Allanore Y., Distler O., Bielecka O.K., Matucci-Cerinic M., H.L. Low A., Teng G.G., Law W.G., Santosa A., Nikpour M., Hill C., Lester S., Nash P., Ngian G.-S., Proudman S., Rischmueller M., Roddy J., Strickland G., Thakkar V., Walker J., Zochling J., Pope J., Markland J., Robinson D., Jones N., Khalidi N., Docherty P., Kaminska E., Masetto A., Sutton E., Mathieu J.-P., Ligier S., Grodzicky T., LeClercq S., Thorne C., Gyger G., Smith D., Fortin P.R., Larche M., Abu-Hakima M., Rodriguez-Reyna T.S., Cabral A.R., Fritzler M., Avouac J., Walker U.A., Guiducci S., Riemekasten G., Air P., Hachulla E., Valentini G., Carreira P.E., Cozzi F., Gurman A.B., Braun-Moscovici Y., Damjanov N., Ananieva L.P., Scorza R., Jimenez S., Busquets J., Li M., Muller-Ladner U., Maurer B., Tyndall A., Lapadula G., Becvar R., Sierakowsky S., Cutolo M., Sulli A., Cuomo G., Vettori S., Rednic S., Nicoara I., Vlachoyiannopoulos P., Montecucco C., Caporali R., Novak S., Czirjak L., Varju C., Chizzolini C., Kucharz E.J., Kotulska A., Kopec-Medrek M., Widuchowska M., Rozman B., Mallia C., Coleiro B., Gabrielli A., Farge D., Hij A., Hesselstrand R., Scheja A., Wollheim F., Martinovic D., Govoni M., Lo Monaco A., Hunzelmann N., Pellerito R., Bambara L.M., Caramaschi P., Black C., Denton C., Henes J., Santamaria V.O., Heitmann S., Krasowska D., Seidel M., Oleszowsky M., Burkhardt H., Himsel A., Salvador M.J., Stamenkovic B., Stankovic A., Tikly M., Starovoytova M.N., Engelhart M., Strauss G., Nielsen H., Damgaard K., Szucs G., Mendoza A.Z., de la Puente Buijdos C., Giraldo W.A.S., Midtvedt O., Garen T., Launay D., Valesini G., Riccieri V., Ionescu R.M., Opris D., Groseanu L., Wigley F.M., Mihai C.M., Cornateanu R.S., Ionitescu R., Gherghe A.M., Gorga M., Dobrota R., and Bojinca M.

Abstract

Introduction: The aim of this study is to compare the clinical features, mortality and causes of death of systemic sclerosis (SSc) patients in four large multicentre registries. Method(s): Patients seen at least once in the Australian Scleroderma Cohort Study (ASCS) (n = 1714), the Canadian Scleroderma Research Group (CSRG) (n = 1628), the European League Against Rheumatism Scleroderma Trials and Research (EUSTAR) Network (n = 13,996) and the Systemic Sclerosis Cohort in Singapore (SCORE) (n = 500) before August 2016 were included. Clinical manifestations and survival in cohorts and disease subtypes were compared. Result(s): Among 17,838 SSc patients, most were female (86.1%), Caucasian (84.6%) and had the limited cutaneous subtype (lcSSc) (65.0%). The anti-centromere autoantibody was the most prevalent (37.6%). More patients in SCORE had the diffuse subtype (dcSSc) (49.3%) and Scl-70 autoantibody (38.8%) (p<0.001). Patients with dcSSc were more likely to be younger and male (p<0.001) and have shorter disease duration, more calcinosis, tendon friction rubs and synovitis (all p<0.001). Interstitial lung disease (ILD) occurred more frequently in dcSSc but prevalence of pulmonary arterial hypertension (PAH) was similar in both subtypes. More deaths occurred among SCORE patients who had the shortest median survival (p<0.001). The survival of patients with early disease, males and those with dcSSc was shorter than that of patients with prevalent disease, female gender and lcSSc, respectively. SSc-related complications accounted for more than 50% of deaths, with PAH and ILD being the most common. Conclusion(s): This meta-cohort of SSc patients, the largest reported to date, provides insights into the impact of race and sex on disease manifestations and survival and confirms the early mortality in this disease.Copyright © 2017 Wichtig International

Published
2018

38. Early symptoms of systemic lupus erythematosus (SLE) recalled by 339 SLE patients

Author

Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., Aringer, M., Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., and Aringer, M.

Abstract

Objective: The European League Against Rheumatism and the American College of Rheumatology jointly embarked on a new classification criteria for systemic lupus erythematosus (SLE) project. Its first phase involved generation of a broad set of items potentially useful for classification of SLE. This study was undertaken to add the patient perspective to an expert Delphi approach and an early patient cohort study. Methods: A national cross-sectional study was conducted. A self-report questionnaire was published in the ‘‘Schmetterling’’ (Butterfly), the quarterly journal of the German SLE patient association. Individuals with SLE were asked to anonymously complete the questionnaire, which asked for demographic details, organ manifestations, autoantibodies and symptoms. Results: A total of 339 completed questionnaires out of 2498 were returned, a response rate of 13.6%; 83.2% reported they were ANA positive and 81.7% reported joint, 66.1% skin and 33.0% renal involvement. For the time before and in the first year after their SLE diagnosis, the majority reported fatigue (89.4%), joint pain (86.7%), photosensitivity (79.4%) and myalgia (76.1%). Of interest, more than half of the patients reported fever as an early symptom (53.7%). Conclusion: For a Caucasian European SLE patient population, the overall characteristics suggest meaningful representation. While many symptoms were reported as expected, the high percentage of patients reporting fever and the significant number of patients with unexpected gastrointestinal complaints are of particular interest. These data add to the information on early SLE symptoms informing the development process of new SLE classification criteria.

Published
2018

39. Early symptoms of systemic lupus erythematosus (SLE) recalled by 339 SLE patients

Author

Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., Aringer, M., Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., and Aringer, M.

Abstract

Objective: The European League Against Rheumatism and the American College of Rheumatology jointly embarked on a new classification criteria for systemic lupus erythematosus (SLE) project. Its first phase involved generation of a broad set of items potentially useful for classification of SLE. This study was undertaken to add the patient perspective to an expert Delphi approach and an early patient cohort study. Methods: A national cross-sectional study was conducted. A self-report questionnaire was published in the ‘‘Schmetterling’’ (Butterfly), the quarterly journal of the German SLE patient association. Individuals with SLE were asked to anonymously complete the questionnaire, which asked for demographic details, organ manifestations, autoantibodies and symptoms. Results: A total of 339 completed questionnaires out of 2498 were returned, a response rate of 13.6%; 83.2% reported they were ANA positive and 81.7% reported joint, 66.1% skin and 33.0% renal involvement. For the time before and in the first year after their SLE diagnosis, the majority reported fatigue (89.4%), joint pain (86.7%), photosensitivity (79.4%) and myalgia (76.1%). Of interest, more than half of the patients reported fever as an early symptom (53.7%). Conclusion: For a Caucasian European SLE patient population, the overall characteristics suggest meaningful representation. While many symptoms were reported as expected, the high percentage of patients reporting fever and the significant number of patients with unexpected gastrointestinal complaints are of particular interest. These data add to the information on early SLE symptoms informing the development process of new SLE classification criteria.

Published
2018

40. Early symptoms of systemic lupus erythematosus (SLE) recalled by 339 SLE patients

Author

Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., Aringer, M., Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., and Aringer, M.

Abstract

Objective: The European League Against Rheumatism and the American College of Rheumatology jointly embarked on a new classification criteria for systemic lupus erythematosus (SLE) project. Its first phase involved generation of a broad set of items potentially useful for classification of SLE. This study was undertaken to add the patient perspective to an expert Delphi approach and an early patient cohort study. Methods: A national cross-sectional study was conducted. A self-report questionnaire was published in the ‘‘Schmetterling’’ (Butterfly), the quarterly journal of the German SLE patient association. Individuals with SLE were asked to anonymously complete the questionnaire, which asked for demographic details, organ manifestations, autoantibodies and symptoms. Results: A total of 339 completed questionnaires out of 2498 were returned, a response rate of 13.6%; 83.2% reported they were ANA positive and 81.7% reported joint, 66.1% skin and 33.0% renal involvement. For the time before and in the first year after their SLE diagnosis, the majority reported fatigue (89.4%), joint pain (86.7%), photosensitivity (79.4%) and myalgia (76.1%). Of interest, more than half of the patients reported fever as an early symptom (53.7%). Conclusion: For a Caucasian European SLE patient population, the overall characteristics suggest meaningful representation. While many symptoms were reported as expected, the high percentage of patients reporting fever and the significant number of patients with unexpected gastrointestinal complaints are of particular interest. These data add to the information on early SLE symptoms informing the development process of new SLE classification criteria.

Published
2018

41. Early symptoms of systemic lupus erythematosus (SLE) recalled by 339 SLE patients

Author

Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., Aringer, M., Leuchten, N., Milke, B., Winkler-Rohlfing, B., Daikh, D., Dörner, T., Johnson, S. R., and Aringer, M.

Abstract

Objective: The European League Against Rheumatism and the American College of Rheumatology jointly embarked on a new classification criteria for systemic lupus erythematosus (SLE) project. Its first phase involved generation of a broad set of items potentially useful for classification of SLE. This study was undertaken to add the patient perspective to an expert Delphi approach and an early patient cohort study. Methods: A national cross-sectional study was conducted. A self-report questionnaire was published in the ‘‘Schmetterling’’ (Butterfly), the quarterly journal of the German SLE patient association. Individuals with SLE were asked to anonymously complete the questionnaire, which asked for demographic details, organ manifestations, autoantibodies and symptoms. Results: A total of 339 completed questionnaires out of 2498 were returned, a response rate of 13.6%; 83.2% reported they were ANA positive and 81.7% reported joint, 66.1% skin and 33.0% renal involvement. For the time before and in the first year after their SLE diagnosis, the majority reported fatigue (89.4%), joint pain (86.7%), photosensitivity (79.4%) and myalgia (76.1%). Of interest, more than half of the patients reported fever as an early symptom (53.7%). Conclusion: For a Caucasian European SLE patient population, the overall characteristics suggest meaningful representation. While many symptoms were reported as expected, the high percentage of patients reporting fever and the significant number of patients with unexpected gastrointestinal complaints are of particular interest. These data add to the information on early SLE symptoms informing the development process of new SLE classification criteria.

Published
2018

42. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update

Author

Smolen, J.S., Landewe, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., Vollenhoven, R. van, Aletaha, D., Aringer, M., Boers, M, Buckley, C.D., Buttgereit, F., Bykerk, V., Cardiel, M., Combe, B., Cutolo, M., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gabay, C., Gomez-Reino, J., Gossec, L., Gottenberg, J.-E., Hazes, J.M., Huizinga, T., Jani, M., Karateev, D., Kouloumas, M., Kvien, T., Li, Z., Mariette, X., McInnes, I., Mysler, E., Nash, P., Pavelka, K., Poor, G., Richez, C., Riel, P. van, Rubbert-Roth, A., Saag, K., Silva, J., Stamm, T., Takeuchi, T., Westhovens, R., Wit, M. de, Heijde, D. van der, Smolen, J.S., Landewe, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., Vollenhoven, R. van, Aletaha, D., Aringer, M., Boers, M, Buckley, C.D., Buttgereit, F., Bykerk, V., Cardiel, M., Combe, B., Cutolo, M., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gabay, C., Gomez-Reino, J., Gossec, L., Gottenberg, J.-E., Hazes, J.M., Huizinga, T., Jani, M., Karateev, D., Kouloumas, M., Kvien, T., Li, Z., Mariette, X., McInnes, I., Mysler, E., Nash, P., Pavelka, K., Poor, G., Richez, C., Riel, P. van, Rubbert-Roth, A., Saag, K., Silva, J., Stamm, T., Takeuchi, T., Westhovens, R., Wit, M. de, and Heijde, D. van der

Abstract

Contains fulltext : 177336.pdf (publisher's version ) (Closed access)

Published
2017

43. A framework for remission in SLE: Consensus findings from a large international task force on definitions of remission in SLE (DORIS).

Author

Tincani A., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balazova P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirjak L., Rekvig O.P., Rovensky J., Shoenfeld Y., Smolen J., Van Vollenhoven R., Urowitz M., Van Leeuw B., Vasconcelos C., Voss A., Werth V.P., Zakharova H., Zoma A., Schneider M., Ward M., Derksen R., Doria A., Dorner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Gyori N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrom K., Levy R., MacHado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., Rahman A., Tincani A., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balazova P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirjak L., Rekvig O.P., Rovensky J., Shoenfeld Y., Smolen J., Van Vollenhoven R., Urowitz M., Van Leeuw B., Vasconcelos C., Voss A., Werth V.P., Zakharova H., Zoma A., Schneider M., Ward M., Derksen R., Doria A., Dorner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Gyori N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrom K., Levy R., MacHado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., and Rahman A.

Abstract

Objectives Treat-to-target recommendations have identified 'remission' as a target in systemic lupus erythematosus (SLE), but recognise that there is no universally accepted definition for this. Therefore, we initiated a process to achieve consensus on potential definitions for remission in SLE. Methods An international task force of 60 specialists and patient representatives participated in preparatory exercises, a face-to-face meeting and follow-up electronic voting. The level for agreement was set at 90%. Results The task force agreed on eight key statements regarding remission in SLE and three principles to guide the further development of remission definitions: 1. Definitions of remission will be worded as follows: remission in SLE is a durable state characterised by ...................... (reference to symptoms, signs, routine labs). 2. For defining remission, a validated index must be used, for example, clinical systemic lupus erythematosus disease activity index (SLEDAI)=0, British Isles lupus assessment group (BILAG) 2004 D/E only, clinical European consensus lupus outcome measure (ECLAM)=0; with routine laboratory assessments included, and supplemented with physician's global assessment. 3. Distinction is made between remission off and on therapy: remission off therapy requires the patient to be on no other treatment for SLE than maintenance antimalarials; and remission on therapy allows patients to be on stable maintenance antimalarials, low-dose corticosteroids (prednisone <=5 mg/day), maintenance immunosuppressives and/or maintenance biologics. The task force also agreed that the most appropriate outcomes (dependent variables) for testing the prognostic value (construct validity) of potential remission definitions are: death, damage, flares and measures of health-related quality of life. Conclusions The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes.Copyright © Publish

Published
2017

44. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update

Author

Smolen, J.S. (Josef S.), Landewé, R.B.M. (Robert), Bijlsma, J.W.J. (Hans), Burmester, G.R. (Gerd), Chatzidionysiou, K. (Katerina), Dougados, M. (Maxime), Nam, N. (Nguyen) van, Ramiro, S. (Sofia), Voshaar, M. (Marieke), Van Vollenhoven, R.F. (Ronald F.), Aletaha, D. (Daniel), Aringer, M. (Martin), Boers, M. (Maarten), Buckley, C.D., Buttgereit, F. (Frank), Bykerk, V.P. (Vivian), Cardiel, M. (Mario), Combe, B. (Bernard), Cutolo, M. (Maurizio), Van Eijk-Hustings, Y. (Yvonne), Emery, P. (Paul), Finckh, A. (Axel), Gabay, C. (Cem), Gómez-Reino, J.J. (Juan), Gossec, L. (Laure), Gottenberg, J.-E. (Jacques-Eric), Hazes, J.M.W. (Mieke), Huizinga, T.W.J. (Tom), Jani, M. (Meghna), Karateev, D. (Dmitry), Kouloumas, M. (Marios), Kvien, T.K. (Tore), Li, Z. (Zhanguo), Mariette, X. (Xavier), McInnes, I.B. (Iain), Mysler, E. (Eduardo), Nash, P. (Peter), Pavelka, K. (Karel), Poor, R.A. (Raymond), Richez, C. (Christophe), Riel, P.L.C.M. (Piet) van, Rubbert-Roth, A. (Andrea), Saag, K.G. (Kenneth), Da Silva, J. (Jose), Stamm, T. (Tanja), Takeuchi, T. (Tsutomu), Westhovens, R. (René), M. de Wit (Maarten), Van Der Heijde, D. (Désirée), Smolen, J.S. (Josef S.), Landewé, R.B.M. (Robert), Bijlsma, J.W.J. (Hans), Burmester, G.R. (Gerd), Chatzidionysiou, K. (Katerina), Dougados, M. (Maxime), Nam, N. (Nguyen) van, Ramiro, S. (Sofia), Voshaar, M. (Marieke), Van Vollenhoven, R.F. (Ronald F.), Aletaha, D. (Daniel), Aringer, M. (Martin), Boers, M. (Maarten), Buckley, C.D., Buttgereit, F. (Frank), Bykerk, V.P. (Vivian), Cardiel, M. (Mario), Combe, B. (Bernard), Cutolo, M. (Maurizio), Van Eijk-Hustings, Y. (Yvonne), Emery, P. (Paul), Finckh, A. (Axel), Gabay, C. (Cem), Gómez-Reino, J.J. (Juan), Gossec, L. (Laure), Gottenberg, J.-E. (Jacques-Eric), Hazes, J.M.W. (Mieke), Huizinga, T.W.J. (Tom), Jani, M. (Meghna), Karateev, D. (Dmitry), Kouloumas, M. (Marios), Kvien, T.K. (Tore), Li, Z. (Zhanguo), Mariette, X. (Xavier), McInnes, I.B. (Iain), Mysler, E. (Eduardo), Nash, P. (Peter), Pavelka, K. (Karel), Poor, R.A. (Raymond), Richez, C. (Christophe), Riel, P.L.C.M. (Piet) van, Rubbert-Roth, A. (Andrea), Saag, K.G. (Kenneth), Da Silva, J. (Jose), Stamm, T. (Tanja), Takeuchi, T. (Tsutomu), Westhovens, R. (René), M. de Wit (Maarten), and Van Der Heijde, D. (Désirée)

Abstract

Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to-or adding-another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatolog

Published
2017
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45. A framework for remission in SLE: Consensus findings from a large international task force on definitions of remission in SLE (DORIS).

Author

Tincani A., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balazova P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirjak L., Rekvig O.P., Rovensky J., Shoenfeld Y., Smolen J., Van Vollenhoven R., Urowitz M., Van Leeuw B., Vasconcelos C., Voss A., Werth V.P., Zakharova H., Zoma A., Schneider M., Ward M., Derksen R., Doria A., Dorner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Gyori N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrom K., Levy R., MacHado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., Rahman A., Tincani A., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balazova P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirjak L., Rekvig O.P., Rovensky J., Shoenfeld Y., Smolen J., Van Vollenhoven R., Urowitz M., Van Leeuw B., Vasconcelos C., Voss A., Werth V.P., Zakharova H., Zoma A., Schneider M., Ward M., Derksen R., Doria A., Dorner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Gyori N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrom K., Levy R., MacHado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., and Rahman A.

Abstract

Objectives Treat-to-target recommendations have identified 'remission' as a target in systemic lupus erythematosus (SLE), but recognise that there is no universally accepted definition for this. Therefore, we initiated a process to achieve consensus on potential definitions for remission in SLE. Methods An international task force of 60 specialists and patient representatives participated in preparatory exercises, a face-to-face meeting and follow-up electronic voting. The level for agreement was set at 90%. Results The task force agreed on eight key statements regarding remission in SLE and three principles to guide the further development of remission definitions: 1. Definitions of remission will be worded as follows: remission in SLE is a durable state characterised by ...................... (reference to symptoms, signs, routine labs). 2. For defining remission, a validated index must be used, for example, clinical systemic lupus erythematosus disease activity index (SLEDAI)=0, British Isles lupus assessment group (BILAG) 2004 D/E only, clinical European consensus lupus outcome measure (ECLAM)=0; with routine laboratory assessments included, and supplemented with physician's global assessment. 3. Distinction is made between remission off and on therapy: remission off therapy requires the patient to be on no other treatment for SLE than maintenance antimalarials; and remission on therapy allows patients to be on stable maintenance antimalarials, low-dose corticosteroids (prednisone <=5 mg/day), maintenance immunosuppressives and/or maintenance biologics. The task force also agreed that the most appropriate outcomes (dependent variables) for testing the prognostic value (construct validity) of potential remission definitions are: death, damage, flares and measures of health-related quality of life. Conclusions The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes.Copyright © Publish

Published
2017

46. IMPACT OF RITUXIMAB IN COMBINATION WITH LEFLUNOMIDE AND RITUXIMAB RETREATMENT WITH TWO DIFFERENT DOSAGES ON PATIENT-REPORTED OUTCOMES: RESULTS FROM A MULTICENTER RANDOMIZED PLACEBO CONTROLLED INVESTIGATOR INITIATED CLINICAL TRIAL IN ACTIVE RHEUMATOID ARTHRITIS (AMARA-STUDY)

Author

Koehm, M., Rossmanith, T., Dauth, S., Alten, R., Aringer, M., Backhaus, M., Burmester, G., Feist, E., Kellner, H., Krueger, K., Mueller-Ladner, U., Rubbert-Roth, A., Tony, H-P., Wassenberg, S., Burkhardt, H., Behrens, F., Koehm, M., Rossmanith, T., Dauth, S., Alten, R., Aringer, M., Backhaus, M., Burmester, G., Feist, E., Kellner, H., Krueger, K., Mueller-Ladner, U., Rubbert-Roth, A., Tony, H-P., Wassenberg, S., Burkhardt, H., and Behrens, F.

Published
2017

47. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update

Author

Smolen, J.S., Landewe, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., Vollenhoven, R. van, Aletaha, D., Aringer, M., Boers, M, Buckley, C.D., Buttgereit, F., Bykerk, V., Cardiel, M., Combe, B., Cutolo, M., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gabay, C., Gomez-Reino, J., Gossec, L., Gottenberg, J.-E., Hazes, J.M., Huizinga, T., Jani, M., Karateev, D., Kouloumas, M., Kvien, T., Li, Z., Mariette, X., McInnes, I., Mysler, E., Nash, P., Pavelka, K., Poor, G., Richez, C., Riel, P. van, Rubbert-Roth, A., Saag, K., Silva, J., Stamm, T., Takeuchi, T., Westhovens, R., Wit, M. de, Heijde, D. van der, Smolen, J.S., Landewe, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., Vollenhoven, R. van, Aletaha, D., Aringer, M., Boers, M, Buckley, C.D., Buttgereit, F., Bykerk, V., Cardiel, M., Combe, B., Cutolo, M., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gabay, C., Gomez-Reino, J., Gossec, L., Gottenberg, J.-E., Hazes, J.M., Huizinga, T., Jani, M., Karateev, D., Kouloumas, M., Kvien, T., Li, Z., Mariette, X., McInnes, I., Mysler, E., Nash, P., Pavelka, K., Poor, G., Richez, C., Riel, P. van, Rubbert-Roth, A., Saag, K., Silva, J., Stamm, T., Takeuchi, T., Westhovens, R., Wit, M. de, and Heijde, D. van der

Abstract

Contains fulltext : 177336.pdf (publisher's version ) (Closed access)

Published
2017

48. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update

Author

Smolen, J.S., Landewe, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., Vollenhoven, R. van, Aletaha, D., Aringer, M., Boers, M, Buckley, C.D., Buttgereit, F., Bykerk, V., Cardiel, M., Combe, B., Cutolo, M., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gabay, C., Gomez-Reino, J., Gossec, L., Gottenberg, J.-E., Hazes, J.M., Huizinga, T., Jani, M., Karateev, D., Kouloumas, M., Kvien, T., Li, Z., Mariette, X., McInnes, I., Mysler, E., Nash, P., Pavelka, K., Poor, G., Richez, C., Riel, P. van, Rubbert-Roth, A., Saag, K., Silva, J., Stamm, T., Takeuchi, T., Westhovens, R., Wit, M. de, Heijde, D. van der, Smolen, J.S., Landewe, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., Vollenhoven, R. van, Aletaha, D., Aringer, M., Boers, M, Buckley, C.D., Buttgereit, F., Bykerk, V., Cardiel, M., Combe, B., Cutolo, M., Eijk-Hustings, Y. van, Emery, P., Finckh, A., Gabay, C., Gomez-Reino, J., Gossec, L., Gottenberg, J.-E., Hazes, J.M., Huizinga, T., Jani, M., Karateev, D., Kouloumas, M., Kvien, T., Li, Z., Mariette, X., McInnes, I., Mysler, E., Nash, P., Pavelka, K., Poor, G., Richez, C., Riel, P. van, Rubbert-Roth, A., Saag, K., Silva, J., Stamm, T., Takeuchi, T., Westhovens, R., Wit, M. de, and Heijde, D. van der

Abstract

Contains fulltext : 177336.pdf (publisher's version ) (Closed access)

Published
2017

49. Impact of different dosages of rituximab in combination with leflunomide as retreatment on efficacy and safety measurements in patients with rheumatoid arthritis (AMARA-study)

Author

Behrens, F, Köhm, M, Rossmanith, T, Dauth, S, Alten, RHE, Burmester, GR, Feist, E, Aringer, M, Krüger, K, Müller-Ladner, U, Rubbert-Roth, A, Wassenberg, S, Tony, HP, Kellner, H, Backhaus, M, Burkhardt, HL, Behrens, F, Köhm, M, Rossmanith, T, Dauth, S, Alten, RHE, Burmester, GR, Feist, E, Aringer, M, Krüger, K, Müller-Ladner, U, Rubbert-Roth, A, Wassenberg, S, Tony, HP, Kellner, H, Backhaus, M, and Burkhardt, HL

Published
2017

50. Wechsel von Tocilizumab i.v. auf s.c. ohne Wirkverlust möglich

Author

Specker, C, Kaufmann, J, Kellner, H, Kästner, P, Volberg, C, Schwarze, I, Aringer, M, Sieburg, M, Meier, L, Hofmann, MW, Flacke, JP, Tony, HP, Fliedner, G, Specker, C, Kaufmann, J, Kellner, H, Kästner, P, Volberg, C, Schwarze, I, Aringer, M, Sieburg, M, Meier, L, Hofmann, MW, Flacke, JP, Tony, HP, and Fliedner, G

Published
2017

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