https://doi.org/10.4081/reumatismo.2024.1725
PASSing to the patient side: early achieving of an acceptable symptom state in patients with rheumatoid arthritis treated with Janus kinase inhibitors
Submitted: 20 March 2024
Accepted: 19 June 2024
Published: 5 November 2024
Accepted: 19 June 2024
Abstract Views: 910
PDF: 248
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Objective. Patients Acceptable Symptom State (PASS) is a single dichotomized question assessing health satisfaction. We aimed to investigate PASS achievement within 4 weeks of treatment with Janus kinase (JAK) inhibitors (Jakinibs) and its association with treatment response after 4 and 12 weeks in rheumatoid arthritis (RA) patients.
Methods. We recruited consecutive RA patients starting baricitinib or tofacitinib. At baseline, 4 and 12 weeks, we calculated disease activity [Disease Activity Score on 28 joints (DAS28), Clinical Disease Activity Index, Simplified Disease Activity Index], disease status [remission and low-disease activity (LDA)], percentage of patients achieving PASS, and the time to attain PASS. We assessed the impact of clinically relevant variables on PASS achievement by logistic regression analysis.
Results. We enrolled 113 patients [98 (86.7%) females; median age 59.6 (interquartile range 16.9), median disease duration 144 (132) months]. 90 (79.6%) patients achieved PASS after 10 (8) days. A similar percentage of PASS achievers and non-achievers was in remission/LDA at weeks 4 and 12, but the reduction of disease activity was significantly greater in PASS achievers. All patients achieving Boolean remission at weeks 4 and 12 had achieved PASS within 4 weeks. The impact of Patients Global Assessment (PGA) on DAS28 was significantly greater in PASS non-achievers compared to PASS achievers; inversely, the impact of C-reactive protein was more relevant in PASS achievers. At multivariate analysis, pain and PGA were significantly associated with PASS.
Conclusions. In our cohort, Jakinibs allowed an early achievement of PASS in a great percentage of RA patients. PASS is strictly dependent on PGA and pain and could suggest, early in the management of RA patients, therapeutic success.
Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int 2021; 41: 863-77.
DOI: https://doi.org/10.1007/s00296-020-04731-0
Van Tuyl LHD, Boers M. Patient’s global assessment of disease activity: what are we measuring? Arthritis Rheum 2012; 64: 2811-3.
DOI: https://doi.org/10.1002/art.34540
Ferreira RJO, Wit MDE, Henriques M, Pinto AF, Duarte C, Mateus E, et al. “It can’t be zero!” Difficulties in completing patient global assessment in rheumatoid arthritis: a mixed methods study. Rheumatology 2020; 59: 1137-47.
DOI: https://doi.org/10.1093/rheumatology/kez467
Bugatti S, De Stefano L, D'Onofrio B, Nicrosini A, Mauric E, di Lernia M, et al. Inflammatory correlates of the patient global assessment of disease activity vary in relation to disease duration and autoantibody status in patients with rheumatoid arthritis. Ann Rheum Dis 2022; 81: 1206-13.
DOI: https://doi.org/10.1136/annrheumdis-2022-222436
Smolen JS, Landewé RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis 2023; 82: 3-18.
DOI: https://doi.org/10.1136/ard-2022-223356corr1
Studenic P, Felson D, de Wit M, Alasti F, Stamm TA, Smolen JS, et al. Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal? Ann Rheum Dis 2020; 79: 445-52.
DOI: https://doi.org/10.1136/annrheumdis-2019-216529
Tubach F, Ravaud P, Beaton D, Boers M, Bombardier C, Felson DT, et al. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol 2007; 34: 1188-93.
Conti F, Ceccarelli F, Massaro L, Pacucci VA, Miranda F, Truglia S, et al. Evaluation of the patient acceptable symptom state (PASS) in Italian patients affected by systemic lupus erythematosus: association with disease activity indices. PLoS One 2013; 8: e73517.
DOI: https://doi.org/10.1371/journal.pone.0073517
Kvamme MK, Kristiansen IS, Lie E, Kvien TK. Identification of cutpoints for acceptable health status and important improvement in patient-reported outcomes, in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J Rheumatol 2010; 37: 26-31.
DOI: https://doi.org/10.3899/jrheum.090449
Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bombardier C, et al. Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: results from a prospective multina. Arthritis Care Res 2012; 64: 1699-707.
DOI: https://doi.org/10.1002/acr.21747
Salaffi F, Carotti M, Gutierrez M, Carlo MDI, Angelis R DE. Patient acceptable symptom state in self-report questionnaires and composite clinical disease index for assessing rheumatoid arthritis activity: identification of cut-off points for routine care. Biomed Res Int 2015; 2015: 930756.
DOI: https://doi.org/10.1155/2015/930756
Duarte C, Santos E, Kvien TK, Dougados M, de Wit M, Gossec L, et al. Attainment of the patient-acceptable symptom state in 548 patients with rheumatoid arthritis: influence of demographic factors. Joint Bone Spine 2021; 88: 105071.
DOI: https://doi.org/10.1016/j.jbspin.2020.09.003
Dörner T, Tanaka Y, Petri MA, Smolen JS, Wallace DJ, Dow ER, et al. Baricitinib-associated changes in global gene expression during a 24-week phase II clinical systemic lupus erythematosus trial implicates a mechanism of action through multiple immune-related pathways. Lupus Sci Med 2020; 7: e000424.
DOI: https://doi.org/10.1136/lupus-2020-000424
Emery P, Blanco R, Maldonado Cocco J, Chen YC, Gaich CL, DeLozier AM, et al. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis. RMD Open 2017; 3: e000410.
DOI: https://doi.org/10.1136/rmdopen-2016-000410
Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, et al. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis 2017; 76: 1853-61.
DOI: https://doi.org/10.1136/annrheumdis-2017-211259
Guidelli GM, Viapiana O, Luciano N, De Santis M, Boffini N, Quartuccio L, et al. Efficacy and safety of baricitinib in 446 patients with rheumatoid arthritis: a real-life multicentre study. Clin Exp Rheumatol 2021; 39: 868-73.
DOI: https://doi.org/10.55563/clinexprheumatol/pudtpo
Deprez V, Monnier L LE, Sobhy-danial J-M, Grados F, Henry-Desailly I, Salomon-Goëb S, et al. Therapeutic maintenance of baricitinib and tofacitinib in real life. J Clin Med 2020; 9: 3319.
DOI: https://doi.org/10.3390/jcm9103319
Spinelli F, Ceccarelli F, Garufi C, Duca I, Mancuso S, Cipriano E, et al. Effectiveness and safety of baricitinib in rheumatoid arthritis: a monocentric, longitudinal, real-life experience. Clin Exp Rheumatol 2021; 39: 525-31.
DOI: https://doi.org/10.55563/clinexprheumatol/lfg83z
Bird P, Littlejohn G, Butcher B, Smith T, de Fonseca Pereira C, Witcombe D, et al. Real-world evaluation of effectiveness, persistence, and usage patterns of tofacitinib in treatment of rheumatoid arthritis in Australia. Clin Rheumatol 2020; 39: 2545-51.
DOI: https://doi.org/10.1007/s10067-020-05021-7
Fitton J, Melville AR, Emery P, Nam JL, Buch MH. Real-world single centre use of JAK inhibitors across the rheumatoid arthritis pathway. Rheumatology 2021: 60: 4048-54.
DOI: https://doi.org/10.1093/rheumatology/keaa858
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 2rd, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 2010; 62: 2569-81.
DOI: https://doi.org/10.1002/art.27584
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RL, et al. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum 2016; 46: 319-29.
DOI: https://doi.org/10.1016/j.semarthrit.2016.08.012
Navarro-Compán V, Gherghe AM, Smolen JS, Aletaha D, Landewé R, Van Der Heijde D. Relationship between disease activity indices and their individual components and radiographic progression in RA: a systematic literature review. Rheumatology 2015; 54: 994-1007.
DOI: https://doi.org/10.1093/rheumatology/keu413
Ferreira RJO, Carvalho PD, Ndosi M, Duarte C, Chopra A, Murphy E, et al. Impact of patient’s global assessment on achieving remission in patients with rheumatoid arthritis: a multinational study using the METEOR database. Arthritis Care Res 2019; 71: 1317-25.
DOI: https://doi.org/10.1002/acr.23866
Brites L, Rovisco J, Costa F, Dinis de Freitas JP, Jesus D, Eugénio G, et al. High patient global assessment scores in patients with rheumatoid arthritis otherwise in remission do not reflect subclinical inflammation. Joint Bone Spine 2021; 88: 105242.
DOI: https://doi.org/10.1016/j.jbspin.2021.105242
Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet 2013; 381: 451-60.
DOI: https://doi.org/10.1016/S0140-6736(12)61424-X
Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in patients with refractory rheumatoid arthritis. Nel Egl J Med 2016; 374: 1243-52.
DOI: https://doi.org/10.1056/NEJMoa1507247
Benaglio F, Fornaro M, Montecucco C, Raffeiner B, Di Franco M, et al. Methotrexate in Italian patients wiTh Rheumatoid Arthritis (MITRA study): an observational study about the use of methotrexate in early RA patients and the adherence to the EULAR 2013 recommendations. a project of the Italian Society for Rheumatology. Clin Exp Rheumatol 2021; 39: 1077-84.
DOI: https://doi.org/10.55563/clinexprheumatol/8uy6vj
Heiberg TT, Kvien TK, Mowinckel P, Aletaha D, Smolen JS, Hagen KB. Identification of disease activity and health status cut-off points for the symptom state acceptable to patients with rheumatoid arthritis. Ann Rheum Dis 2008; 67: 967-71.
DOI: https://doi.org/10.1136/ard.2007.077503
Katchamart W, Narongroeknawin P, Suppa-Udom B, Chanapai W, Srisomnuek A. Factors associated with and cutoff points for patient acceptable symptom state (PASS) in rheumatoid arthritis. Clin Rheumatol 2020; 39: 779-86.
DOI: https://doi.org/10.1007/s10067-019-04860-3
Puyraimond-zemmour D, Etcheto A, Fautrel B, Balanescu A, de Wit M, Heiberg T, et al. Associations between five important domains of health and the patient acceptable symptom state in rheumatoid arthritis and psoriatic arthritis: a cross-sectional study of 977 patients. Arthritis Care Res 2017; 69: 1504-9.
DOI: https://doi.org/10.1002/acr.23176
Spinelli FR, Garufi C, Mancuso S, Ceccarelli F, Truglia S, Conti F. Tapering and discontinuation of glucocorticoids in patients with rheumatoid arthritis treated with tofacitinib. Sci Rep 2023; 13: 15537.
DOI: https://doi.org/10.1038/s41598-023-42371-z
D'Alessandro F, Cazzato M, Laurino E, Morganti R, Bardelli M, Frediani M, et al. ToRaRI (tofacitinib in rheumatoid arthritis a real-life experience in Italy): effectiveness, safety profile of tofacitinib and concordance between patient-reported outcomes and physician's global assessment of disease activity in a retrospective study in central-Italy. Clin Rheumatol 2024; 43: 657-65.
DOI: https://doi.org/10.1007/s10067-023-06836-w
Crispino N, Ciccia F. JAK/STAT pathway and nociceptive cytokine signalling in rheumatoid arthritis and psoriatic arthritis. Clin Exp Rheumatol 2020; 39: 668-75.
DOI: https://doi.org/10.55563/clinexprheumatol/e7ayu8
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med 2022; 386: 316-26.
DOI: https://doi.org/10.1056/NEJMoa2109927
Parisi S, Becciolini A, Ditto MC, Lo Gullo A, Larosa M, Scolieri P, et al. Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients. Curr Res Pharmacol Drug Discov 2024; 6: 100178.
DOI: https://doi.org/10.1016/j.crphar.2024.100178
Baldi C, Berlengiero V, Falsetti P, Cartocci A, Conticini E, D’Alessandro R, et al. Baricitinib retention rate: 'real-life' data from a mono-centric cohort of patients affected by rheumatoid arthritis. Front Med 2023; 10: 1176613.
DOI: https://doi.org/10.3389/fmed.2023.1176613
How to Cite
Garufi, C., Mancuso, S., Ceccarelli, F., Caruso, L., Alessandri, C., Di Franco, M., … Spinelli, F. (2024). PASSing to the patient side: early achieving of an acceptable symptom state in patients with rheumatoid arthritis treated with Janus kinase inhibitors. Reumatismo. https://doi.org/10.4081/reumatismo.2024.1725
Copyright (c) 2024 the Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
Similar Articles
- M. Capraro, M. Dalla Valle, M. Podswiadek, P. De Sandre, E. Sgnaolin, R. Ferrari, The role of illness perception and emotions on quality of life in fibromyalgia compared with other chronic pain conditions , Reumatismo: Vol. 64 No. 3 (2012)
- S.L. Bello, L. Serafino, C. Bonali, N. Terlizzi, C. Fanizza, C. Anecchino, G. Lapaldula, Incidence of influenza-like illness into a cohort of patients affected by chronic inflammatory rheumatism and treated with biological agents , Reumatismo: Vol. 64 No. 5 (2012)
- S. Canestri, M.C. Totaro, E. Serone, B. Tolusso, D. Frezza, E. Gremese, G. Ferraccioli, Association between the response to B cell depletion therapy and the allele*2 of the HS1,2A enhancer in seropositive rheumatoid arthritis patients , Reumatismo: Vol. 64 No. 6 (2012)
- Y. Emad, T. Gheita, H. Darweesh, P. Klooster, R. Gamal, H. Fathi, N. El-Shaarawy, M. Gamil, M. Hawass, R.M. El-Refai, H. Al-Hanafi, S. Abd-Ellatif, A. Ismail, J. Rasker, Antibodies to extractable nuclear antigens (ENAS) in systemic lupus erythematosus patients: correlations with clinical manifestations and disease activity , Reumatismo: Vol. 70 No. 2 (2018)
- F. Salaffi, A. Ciapetti, P. Sarzi Puttini, F. Atzeni, C. Iannuccelli, M. Di Franco, M. Cazzola, L. Bazzichi, Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience , Reumatismo: Vol. 64 No. 1 (2012)
- C.-N. Lo, G. Xia, B.P. Leung, The effect of nerve mobilization exercise in patients with rheumatoid arthritis: a pilot study , Reumatismo: Vol. 69 No. 3 (2017)
- M. Fredi, M. Bianchi, L. Andreoli, G. Greco, I. Olivieri, S. Orcesi, E. Fazzi, C. Cereda, A. Tincani, Typing TREX1 gene in patients with systemic lupus erythematosus , Reumatismo: Vol. 67 No. 1 (2015)
- S. Casigliani Rabl, A. Della Rossa, P. Pepe, A. D'Ascanio, M. Mosca, A. Di Vita, S. Bombardieri, Long-term cyclic intravenous iloprost in systemic sclerosis: clinical experience from a single center , Reumatismo: Vol. 64 No. 3 (2012)
- M. Taraborelli, F. Inverardi, M. Fredi, A. Ceribelli, I. Cavazzana, A. Tincani, F. Franceschini, Anti-cyclic citrullinated peptide antibodies in systemic lupus erythematosus patients with articular involvement: a predictive marker for erosive disease? , Reumatismo: Vol. 64 No. 5 (2012)
- P. Sarzi-Puttini, F. Salaffi, M. Di Franco, L. Bazzichi, G. Cassisi, R. Casale, M. Cazzola, S. Stisi, M. Battellino, F. Atzeni, Pain in rheumatoid arthritis: a critical review , Reumatismo: Vol. 66 No. 1 (2014)
You may also start an advanced similarity search for this article.
