L'impact de la durée de la rémission booléenne pour un contrôle strict de l'activité de la maladie après acquisition chez les patients atteints de polyarthrite rhumatoïde
May 28, 2024Rapports scientifiques volume 13, Numéro d'article : 13908 (2023) Citer cet article
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L'importance clinique du délai écoulé entre le début de la stratégie traiter-cible (T2T) et l'acquisition d'une rémission clinique (TL) dans le traitement des patients atteints de polyarthrite rhumatoïde (PR) sur le contrôle de l'activité de la maladie, les activités quotidiennes et le maintien de la qualité de vie a été étudiée. Chez les patients ayant obtenu une rémission booléenne une ou plusieurs fois, relation entre le TL et les données de base du patient au début, et relation entre le TL et le score simplifié moyen d'activité de la maladie (SDAI), le score de l'indice d'incapacité du questionnaire d'évaluation de la santé (HAQ-DI), le score de douleur avec l'échelle visuelle analogique (PS-VAS), le score Sharp/van der Heijde (SHS) et le score de qualité de vie (QOLS) lors de la première rémission et par la suite ont été évalués statistiquement. Les patients ont été divisés en deux groupes, que la TL soit inférieure ou égale à 6 mois (G ≤ 6 et G > 6). La modification des paramètres et le taux de rémission booléenne (BRR) après la première rémission entre les deux groupes ont été comparés statistiquement. Chez 465 patients, le TL était significativement corrélé au score SDAI, au score HAQ, au PS-VAS, au SHS et à la QOLS après la rémission. Le score SDAI et le BRR après la rémission étaient significativement meilleurs dans le G ≤ 6 que dans le G > 6. Le TL est une clé importante pour garantir une évolution clinique bonne et stable dans le traitement sous T2T.
Il existe un large consensus sur le fait que la rémission clinique devrait être l'objectif initial du traitement de la polyarthrite rhumatoïde (PR)1,2,3,4,5, car la majorité des pratiques et essais cliniques ont rapporté le bénéfice de l'obtention d'une rémission clinique sur la perturbation des dommages radiographiques et maintien de l'activité quotidienne6,7,8,9,10,11,12,13,14. La rémission clinique est indexée avec des critères booléens, un score de l'indice d'activité de la maladie simplifié (SDAI)10, 15, 16, un score de l'indice d'activité clinique de la maladie (CDAI)16 et un score d'activité de la maladie de 28 articulations utilisant la protéine C-réactive (DAS28-CRP)17. En pratique clinique, le maintien d'une rémission clinique est l'objectif du traitement pour les patients atteints de PR, qui améliorerait la destruction radiographique des articulations, les activités quotidiennes de la vie (AVQ) et la qualité de vie (QOL)18,19,20,21,22,23. . Pour ces patients, les critères booléens de rémission pourraient être les critères les plus stricts et garantiraient de meilleurs résultats cliniques tant en termes d’activité de la maladie que de progression radiographique21, 24,25,26.
En revanche, malgré la forte recommandation de la Ligue européenne contre les rhumatismes (EULAR) selon laquelle une rémission clinique de la PR doit être obtenue dans les 3 à 6 mois suivant la première visite chez un rhumatologue3,4,5, l'impact d'une rémission clinique précoce sur les résultats cliniques ne sont pas suffisamment discutés. Bien que dans la littérature, il soit suggéré que l'acquisition précoce d'une rémission clinique peut permettre d'obtenir de meilleurs résultats cliniques grâce à un contrôle strict de la maladie27, cela a été rapporté avant de préconiser la stratégie de traitement pour cibler (T2T). À notre connaissance, aucune étude n'a rapporté l'impact de l'obtention précoce d'une rémission clinique dans le cadre de la stratégie T2T sur des cours cliniques complets.
Par conséquent, nous avons étudié cette question en utilisant de petites données de cohorte ; l'impact du temps nécessaire pour obtenir une rémission booléenne sur les résultats cliniques a été évalué statistiquement et expliqué pourquoi un délai de 3 à 6 mois pour atteindre est un objectif approprié.
Au total, 685 patients atteints de PR ont été recrutés. Parmi eux, 465 patients avaient obtenu une rémission booléenne une ou plusieurs fois. Sur 465 patients, 343 étaient des femmes (73,7 %) et l'âge moyen était de 67,8 ans (allant de 21 à 95 ans). Ces patients ont été analysés dans l’étude. La durée moyenne de la maladie lors de la première visite était de 6,1 ans (intervalle de 1 mois à 45 ans) et aucun cas n'a démontré une rémission booléenne lors de la première visite. Le titre moyen d'anticorps anti-peptide citrulliné cyclique (ACPA) était de 197,4 U/L et 336 (72,3 %) patients étaient positifs à l'ACPA, tandis que le titre moyen de RF était de 95,2 UI/mL et 350 (75,3 %) patients étaient positifs. pour RF. La durée moyenne du suivi était de 71,5 mois (intervalle de 36 à 122 mois ; médiane de 85 mois) et la durée moyenne entre la première visite et la première rémission booléenne était de 8,1 mois (intervalle de 1 à 111 mois ; médiane de 4 mois). Le score moyen SDAI, le score HAQ-DI (Health Assessment Questionnaire Disability Index), le score de douleur utilisant une échelle visuelle analogique (PS-VAS), le score Sharp/van der Heijde (SHS) et le score de qualité de vie (QOLS) à la première visite sont présentées dans le tableau 1.
6 groups revealed that the disease duration, HAQ-DI score, PS-VAS, and SHS at baseline in the G > 6 were significantly higher than that in the G ≤ 6 group, and QOLS in the G ≤ 6 group was significantly higher than that in the G > 6 group at baseline (Table 1). Similarly, the HAQ-DI score, SHS, and PS-VAS at the first Boolean remission in the G > 6 group were significantly higher than that in the G ≤ 6 group, whereas QOLS in the G ≤ 6 group demonstrated no significant difference compared with that in the G > 6 group. In summarize, the G > 6 group had different characteristics at baseline from the G ≤ 6 group had such as longer disease history, higher joint deformity, inferior pain, ALD, and QOL profile, yet no difference in disease activity between the two groups was shown. For treatment detail, mean MTX dosage and b/tsDMARD administration rate in the G > 6 group were significantly higher than those in the G ≤ 6 group at the first Boolean remission, despite there being no significant difference between the two groups at baseline. The other parameters showed no significant differences between the two groups (Table 4)./p> 6 group was significantly higher than that in the G ≤ 6 group. Similarly, the SDAI score, the HAQ-DI score, PS-VAS, and SHS after the first Boolean remission to the last observation in the G > 6 group were also significantly higher than those in the G ≤ 6 group, and the mean value of the QOLS in the G ≤ 6 group was significantly higher than that in the G > 6 group. The Boolean remission rate and SDAI remission rate after the first Boolean remission to the last observation were significantly higher in the G ≤ 6 group than those in the G > 6 group (Table 4). The change of the SDAI score from the first Boolean remission to after the remission was significantly lower in the G ≤ 6 group than that in the G > 6 group, whereas the changes in the HAQ-DI score, PS-VAS, SHS, and QOLS demonstrated no significant differences between the two groups (Table 5)./p> 6 group (p < 0.001), and QOLS in the G ≤ 6 group was significantly higher than that in the G > 6 group (p < 0.01). The change value of the SDAI score in the G ≤ 6 group was significantly lower than that in the G > 6 group at any moment from one to three years after the first Boolean remission (p < 0.001). The SDAI scores at one to three year after compared to that at the first Boolean remission were significantly higher in both groups (p < 0.001), whereas the PS-VAS after the first Boolean remission was significantly higher than that at the remission, and the p-values were < 0.05, < 0.05, and < 0.001 at one, two, and three years after, respectively. The QOLS three years after compared to that at the first remission was significantly lower in both groups, and the p-value was < 0.01 and < 0.05 in the G ≤ 6 group and G > 6 group, respectively (Fig. 2)./p> 6. Error bars that show standard deviation in each group were shown at each moment. Except for the SDAI score at the first Boolean remission, mean values of all parameters at any moment were significantly lower in the G ≤ 6 group than those in the G > 6 group (p < 0.001), and the QOLS was significantly higher at any moment in the G ≤ 6 group the those in the G > 6 group at any moment (p < 0.01). Change of mean SDAI score was significantly lower in the G ≤ 6 than in the G > 6 (p < 0.001), and change of the other parameters such as HAQ-DI, PS-VAS, SHS, and QOLS demonstrated no significant difference between the two groups. Statical significances of time change at each moment after the first Boolean remission (BL) for each parameter in the each group compared to the values at the BL were symbolized in the figure (*p < 0.5; **p < 0.01; ***p < 0.001)./p> 3 years, 465 (67.9%) showed Boolean remission once or more, it is realistic, because patients were picked up from various background. That is different from clinical trial study background. Therefore, it can be considered that such a high rate in both of G ≤ 6 and G > 6 groups are realistic given that the Boolean remission achievement rate after the first Boolean remission to the last observation was 62.0% and 43.4%, respectively. However, it is also a fact that some patients could not unfortunately achieve clinical remission, or Boolean remission for some reason such as the reason of patient's personal characteristics, or for some refractory disease status. These patients were excluded from the study./p> 6 months. These results showed that the group who achieved it within 6 months showed significantly better disease activity compared with the group that required > 6 months. The secondary endpoints of the HAQ-DI score, PS-VAS, SHS, and QOLS also showed significantly superior results. However, above all, these parameters were significantly superior in the group that achieved remission within 6 months even at the baseline, and these differences were maintained throughout the treatment./p> 6 group./p> 6 group, despite these parameters demonstrated no significant difference between the two groups at baseline. This may be because the goal of Boolean remission resulted in the need for more intensive treatment compared with the G ≤ 6 group. However, the patient’s drug adherence was not considered in the study. There is a wide variability of drug adherence in patients, which strongly influences clinical results41. Previous treatment including b/tsDMARD administration at baseline did not influence on the time length. Like these, treatment initiation before disease activity gets high may have no influence on the time length because no disease activity difference at baseline was demonstrated between the two groups. The treatment protocol in the study was commonly designed under the T2T strategy, so every patient recruited in the study accepted shared decision-making and had been treated in targeted clinical remission. It seems to be clear that patient-related outcomes (PRO) such as PS-VAS and QOLS, are rather important for obtaining shorter time length. These parameters and the SHS score throughout treatment from baseline to after the first Boolean remission acquisition demonstrated a significant correlation with the time length. These results suggested that a patient who has good PROs from the baseline is well responsible for treatment when tight disease control is targeted./p> 6 group, and this trend persisted after the remission. The parameters improved until the acquisition of Boolean remission and progressively deteriorated after acquisition (Table 5). These parameters after the first remission were significantly correlated with the time length, as shown in Table 3, and parameters other than the SDAI score already showed the same trend at baseline. One confounding factor was mean disease duration at baseline because G > 6 was significantly longer than G ≤ 6. Duration of disease was significantly correlated with all parameters except QOLS (Table 7). This suggested that patients with a longer history obtained a Boolean remission but had a relatively worse clinical course than those with a shorter history./p> 3 years, in the observational study. The time length from the first visit to the first Boolean remission was calculated. The relationship between the time length and each of the background parameters at baseline such as sex, age, disease duration of RA, SHS at the first visit, ACPA, rheumatoid factor (RF), TJC, SJC, PGA, EGA, CRP, SDAI, HAQ-DI, PS-VAS, SHS, and QOLS were evaluated statistically using univariate linear regression analysis, and then multivariate linear regression analysis was performed to evaluate the relationship between the time length and the parameters that demonstrated significant correlation in the univariate model. All data were collected retrospectively from the medical record./p> 6 groups based on the time length for the achievement of first Boolean remission within two groups: G ≤ 6, a patient group who attained Boolean remission within 6 months from the first visit; G > 6, a patient group who attained Boolean remission more than 6 months from the first visit. The two groups were compared with regard to the SDAI score, the HAQ-DI score, PS-VAS, SHS, and QOLS at the first visit and at the time of first Boolean remission, and the values of these parameters at 1–3 years and the mean values of these parameters after the first Boolean remission were assessed using the Mann–Whitney U test. Repeated measures of ANOVA were used for statistical procedures to evaluate the change of these parameters between the moments. Methotrexate (MTX), biologic/targeted disease-modifying anti-rheumatic drug (b/tsDMARD), and glucocorticoid steroid (GCS) administration rate at the first visit were also compared between the two groups using Mann–Whitney U-test. Moreover, changes in these parameters from the first Boolean remission to thereafter between the two groups were also compared using the Mann–Whitney U test. Rates of treatment with mean doses of b/tsDMARD, MTX, and GCS administration rate and mean dose of administration at the first Boolean remission and thereafter between the two groups were also compared using the Mann–Whitney U and chi-square tests. The mean Boolean remission rate after the first remission, and SDAI remission rate at the first Boolean remission and thereafter were also compared between the two groups using the Mann–Whitney U test. The primary endpoint was the mean value of the SDAI score after the first Boolean remission to the last observation, and secondary endpoints included the mean values of the HAQ-DI score, PS-VAS, SHS, and QOLS after the first Boolean remission./p>3.0.CO;2-F" data-track-action="article reference" href="https://doi.org/10.1002%2F1529-0131%28199909%2942%3A9%3C1854%3A%3AAID-ANR9%3E3.0.CO%3B2-F" aria-label="Article reference 8" data-doi="10.1002/1529-0131(199909)42:93.0.CO;2-F"Article CAS PubMed Google Scholar /p>3.0.CO;2-L" data-track-action="article reference" href="https://doi.org/10.1002%2F1529-0131%28200109%2944%3A9%3C2009%3A%3AAID-ART349%3E3.0.CO%3B2-L" aria-label="Article reference 44" data-doi="10.1002/1529-0131(200109)44:93.0.CO;2-L"Article CAS PubMed Google Scholar /p>
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