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Proportion of patients reporting improvements ≥MCID in (A) PtGA, (B) Pain, (C) HAQ-DI, (D) FACIT-F, (E) SF-36 PCS and (F) SF-36 MCS (FAS). MCID: ≥10 mm decrease from baseline in PtGA and Pain; ≥0.22-point decrease from baseline in HAQ-DI score; ≥2.5-point increase from baseline in SF-36 PCS and MCS scores; ≥4-point increase from baseline in FACIT-F score. *p<0.05 tofacitinib+MTX versus tofacitinib monotherapy; **p<0.01 tofacitinib+MTX versus tofacitinib monotherapy; † p<0.05 ADA+MTX versus tofacitinib monotherapy; ‡ p<0.05 tofacitinib+MTX versus ADA+MTX; ‡ ‡ p<0.01 tofacitinib+MTX versus ADA+MTX. ADA, adalimumab; BID, two times per day; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FAS full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MCS, mental component summary; MTX, methotrexate; Pain, arthritis pain; PCS, physical component summary; PtGA, Patient Global Assessment of Disease Activity; SF-36, 36-Item Short-Form Health Survey.
Source publication
Objective
To provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).
Methods
ORAL Strategy ( NCT02187055 ), a phase IIIB/...
Contexts in source publication
Context 1
... improvements from baseline were reported across all PROs across all treatment arms ( figure 1A-F), and the majority of patients reported improvements ≥MCID ( figure 2A-F). ...
Context 2
... 1; figure 1A). The proportions of patients reporting improvements ≥MCID were similar between all treatment arms at all time points (ranges: 71%-77% at month 3, 72%-76% at month 6, 72%-78% at month 9 and 73%-79% at month 12) ( figure 2A). ...
Context 3
... 1B). The proportions of patients reporting improvements ≥MCID were similar between all Table 1 Baseline patient-reported outcomes and changes from baseline at month 6 (FAS) Baseline, mean (SE) score LSM changes from baseline (±SE) at month 6 treatment arms at all time points (ranges: 71%-76% at month 3, 73%-78% at month 6, 74%-80% at month 9 and 76%-78% at month 12) ( figure 2B). As many as 45% of patients reported Pain scores <20 mm in any treatment arm at any time point, with greater proportions in both combination arms (tofacitinib+MTX [p<0.01] and ADA+MTX [p<0.05]) at month 3 versus tofacitinib monotherapy ( figure 3A). ...
Context 4
... statistically significant differences in LSM changes from baseline in HAQ-DI between treatment arms were reported at any time point, with improvements generally approaching maximal values by month 3 and continuing to month 12 for all treatments (table 1; figure 1C). In all treatment arms, the majority of patients reported improvements ≥MCID ( figure 2C; all >68%). Scores ≤normative HAQ-DI values ranged from 17% to 25%, and scores below functional remission (<0.5 HAQ-DI) ranged from 19% to 32% (online supplementary table S1, available at RMD Open online). ...
Context 5
... LSM changes from baseline and improvements ≥MCID in FACIT-F were similar between tofacitinib+MTX and tofacitinib monotherapy at all time points (all p>0.05; table 1; figure 1D; figure 2D); improvements were comparatively lower for ADA+MTX at months 3 and 6, but this did not reach statistical significance at both time points. The proportions of patients reporting scores ≥normative values (≥40.1) were greater with tofacitinib monotherapy versus ADA+MTX at month 3 (p<0.05); ...
Similar publications
Objective
Evaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH ( NCT02332590 ); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).
Methods
During the 48-week OLE, patients received sarilumab 200 mg subcutaneously once e...
Citations
... JAK signalling has been directly and indirectly associated with the production of inflammatory cytokines, playing a significant role in inflammatory mechanisms 82 . In the studies included in this review, three JAK inhibitors were shown to reduce pain severity in patients with psoriatic and rheumatoid arthritis -tofacitinib 77,78,[83][84][85] , baricitinib 79,[86][87][88] , and upadacitinib 76,89 , throughout over 12 months of treatment 90 . Other disease-modifying drugs further include hydroxychloroquine, methotrexate, and sulfasalazine; however, these were not effective in reducing pain severity in patients with osteoarthritis 91 and chikungunya arthritis 92 . ...
Chronic pain is one of the most important public health concerns, greatly impacting the patients’ quality of life and with high societal and economical costs. Despite advances in the understanding of pain mechanisms and the establishment of several strategies to decrease pain severity in patients, there continues to be a substantial proportion of patients who are refractory to the currently available treatments. Recently, novel pharmacological strategies have been developed for the treatment/management of chronic pain, directed at symptoms and psychological complications of the illness. In this work, we performed a systematic review of the recent advances in pharmacological strategies for chronic pain. For that purpose, we searched a total of four databases (PubMed, Science Direct, Web of Science, and Scopus) for clinical trials testing drugs in patients with chronic pain, completed between the years 2017 and 2021 (1st January 2017 up to 17th November 2021). The different treatments were analysed and compared regarding their effectiveness, indications, and side effects. We included 166 studies, which provided information on 46 796 participants, mostly women (64%). This review pools together data on novel drug therapeutic strategies or improved applications of already known drugs, from opioids to monoclonal antibodies, providing researchers and health professionals with tools to ameliorate human chronic pain research and management.
... Previous studies that compared the efficacy of JAKi vs ADA have shown disparity in findings: studies including the ORAL Standard [11,24], ORAL Strategy [8,25], and FINCH1 [7] reported similar efficacy between JAKi and ADA, and studies such as RA-BEAM [10] and SELECT-COMPARE [9,26] reported superiority of JAKi over ADA in improving RA symptoms and PROs. In the current study, we assessed treatment effectiveness by evaluating the change in CDAI score from baseline and the proportion achieving CDAI-based LDA and remission, and found no differences between ETN, ADA, and JAKi groups at 6-and 12-months follow-up in an adjusted analysis after adjusting for age, gender, history of comorbidities, CDAI, and other covariates. ...
Background
Real-world studies assessing the comparative effectiveness of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) as first-line targeted therapy are scarce. We analyzed the real-world persistence and effectiveness of etanercept (ETN), adalimumab (ADA), and Janus kinase inhibitors (JAKis) as first-line therapy in b/tsDMARD-naïve patients with rheumatoid arthritis (RA).
Methods
Adults (≥ 18 years) enrolled in the CorEvitas RA Registry and initiating ETN, ADA, or a JAKi (alone or in combination with csDMARDs) between November 2012 and June 2021 were included if they had 6 and/or 12 months’ follow-up. Treatment persistence and effectiveness outcomes including the change in Clinical Disease Activity Index (CDAI) and patient-reported outcomes (PROs) were evaluated at follow-up, adjusting for covariates using linear and logistic regression models. An exploratory analysis for patients on monotherapy was also conducted.
Results
Of 1059 ETN, 1327 ADA, and 581 JAKi initiators; 803 ETN, 984 ADA, and 361 JAKi initiators had 6 months’ follow-up. JAKi initiators were older and had a relatively longer disease duration than ETN or ADA initiators (mean age: 61.3 vs 54.5 and 55.5 years; mean duration of RA: 8.1 vs 5.7 and 5.6 years). Unadjusted mean improvements in CDAI and PROs were similar between the groups at 6 months, except the proportion achieving LDA, remission, and MCID in CDAI, which were numerically higher in the ETN and ADA groups vs JAKi group (LDA: 43.4% and 41.9% vs 32.5%; remission: 18.2% and 15.1% vs 11.5%; MCID: 46.5% and 47.8% vs 38.0%). Adjusted effectiveness results did not reveal statistically significant differences between treatment groups at 6 months, with an exception in MCID (odds ratio [95% CI] for JAKi vs ETN: 0.65 [0.43–0.98]). At 6 months, 68.2% of ETN, 68.5% of ADA, and 66.5% of JAKi initiators remained on therapy. The findings at 12 months’ follow-up and sensitivity analysis among monotherapy initiators also showed no differences in effectiveness outcomes between the groups.
Conclusions
This analysis of real-world data from the CorEvitas RA Registry did not show differences in clinical effectiveness and treatment persistence rates in b/tsDMARD-naïve patients initiating ETN, ADA, or JAKi as first-line targeted therapy either alone or in combination with csDMARDs.
... These clinical trials included patients with insufficiency responses to MTX, 94 cDMARDs, 96 or bDMARDs, 97 as well as in patients with early arthritis 95 and TOFA used as monotherapy. 93 In RA, TOFA administration alone or in combination therapy resulted in statistically significant improvement from baseline in all five fatigue-related scores (PtGA, pain, HAQ-DI, FACIT-F, and SF-36) as compared to placebo [92][93][94][95][96][97][98] or MTX that was maintained throughout the duration of TOFA treatment. 95 Furthermore, significantly more patients reported improvement in their physical functioning, which is directly connected with better fatigue control, after treatment with TOFA (10 mg twice a day) vs those treated with ADA. ...
... 95 Furthermore, significantly more patients reported improvement in their physical functioning, which is directly connected with better fatigue control, after treatment with TOFA (10 mg twice a day) vs those treated with ADA. 98 ...
It is well known that fatigue is a highly disabling symptom commonly observed in inflammatory rheumatic diseases (IRDs). Fatigue is strongly associated with a poor quality of life and seems to be an independent predictor of job loss and disability in patients with different rheumatic diseases. Although the pathogenesis of fatigue remains unclear, indirect data suggest the cooperation of the immune system, the central and autonomic nervous system, and the neuroendocrine system in the induction and sustainment of fatigue in chronic diseases. Fatigue does not correspond with disease activity and its mechanism in IRDs. It is suggested that it may change over time and vary between individuals. Abnormal production of pro-inflammatory cytokines such as interleukin-6 (IL-6), interferons (IFNs), granulocyte-macrophage colony-stimulating factor (GM-CSF), TNF, IL-15, IL-17 play a role in both IRDs and subsequent fatigue development. Some of these cytokines such as IL-6, IFNs, GM-CSF, and common gamma-chain cytokines (IL-15, IL-2, and IL-7) activate the Janus Kinases (JAKs) family of intracellular tyrosine kinases. Therapy blocking JAKs (JAK inhibitors – JAKi) has been recently proven to be an effective approach for IRDs treatment, more efficient in pain reduction than anti-TNF. Therefore, the administration of JAKi to IRDs patients experiencing fatigue may find rational implications as a therapeutic modulator not only of disease inflammatory symptoms but also fatigue with its components like pain and neuropsychiatric features as well. In this review, we demonstrate the latest information on the mechanisms of fatigue in rheumatic diseases and the potential effect of JAKi on fatigue reduction.
... There is a study that has investigated the HRQoL of both tofacitinib and adalimumab in patients with RA. In this study, tofacitinib with MTX combination for the treatment of RA had greater improvement of HRQoL than adalimumab with MTX, with at least similar efficacy to adalimumab [15]. ...
... Similar to treatment satisfaction, several different factors also affect HRQoL [30,31]. Therefore, this study could have limitations due to these difficulties although TSQM and EQ-5D are widely authorized and frequently used tools [15,16,19,35]. Third, this study used a selfreported questionnaire; there may be individual differences in understanding of each question. ...
... Tofacitinib and adalimumab have different characteristics, such as drug formulation, route or frequency of administration, and storage method, and these characteristics may have worked in combination to show differences in the convenience domain of treatment satisfaction between the two drugs. In addition, we found no difference of HRQoL based on EQ-5D between tofacitinib and adalimumab, although two drugs had positive effect of QoL on patients with RA [15,27,28]. Because patient's perception for treatment satisfaction and assessment of HRQoL are crucial steps to improving clinical outcomes [21], further prospective studies are needed on various components that can determine treatment satisfaction, including the convenience, and affect HRQoL in patients with RA. ...
Background
As significant advances in the field of treatment for rheumatoid arthritis (RA), there is a great need to identify the healthcare outcomes such as treatment satisfaction and health-related quality of life (HRQoL) of patients with various treatment options. This study aims to identify the difference in the treatment satisfaction and HRQoL of patients with RA using different treatment options, by comparing the treatment satisfaction and HRQoL in patients with RA treated with tofacitinib and adalimumab in real-world settings in Korea, using propensity score methods.
Methods
In this non-interventional, multicenter, cross-sectional study (NCT03703817), a total of 410 patients with RA diagnosis were recruited in 21 university-based hospitals throughout Korea. The treatment satisfaction and HRQoL were assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) and EQ-5D questionnaires self-reported by the patients. This study compared outcomes between two drug groups in unweighted, greedy matching, and stabilized inverse probability of treatment weight (IPTW) samples using propensity score.
Results
In all three samples, tofacitinib group showed higher convenience domain of TSQM than that in the adalimumab group, but not effectiveness, side effects, and global satisfaction domains. Multivariable analysis using the covariates of demographic and clinical characteristics of the participants also showed consistent results in TSQM. No statistical difference in EQ-5D-based HRQoL was identified between two drug groups in all three samples.
Conclusions
This study identified that tofacitinib shows higher treatment satisfaction in the convenience domain of TSQM rather than adalimumab, suggesting that various factors such as drug formulation, route or frequency of administration, and storage can have an impact on the treatment satisfaction, especially the convenience domain. These findings may be useful to patients and physicians when determining treatment options.
Trial registration
ClinicalTrials.gov, NCT03703817.
... SF36 was also used to compare the results of the RA therapy performed with tofacitinib mono or in combination with methotrexate and adalimumab with methotrexate and found that the combination therapy is more effective, but the clinical meaning of the improvements was not significant [32]. ...
The aim of this study was to analyze the therapeutic results of rheumatoid arthritis (RA) therapy with different biologic disease-modifying antirheumatic drugs (bDMARDs) and the first Janus-activated kinase (JAK) inhibitor in real-life clinical settings. This is a prospective, observational, longitudinal study at the largest rheumatology clinic in Bulgaria conducted during the period 2012–2020. One hundred seventy-four patients were followed up for a period of one year. Patients naïve to biological therapy were consecutively assigned on the available at the time bDMARDs (infliximab, etanercept, adalimumab, rituximab, golimumab, cetrolizumab, tocilizumab) or tofacitinib. We evaluated the disease activity score (DAS28-CRP), Health assessment questionnaires (HAQ) and short form 36 (SF-36) were applied at the initiation of biological therapy, after 6, and 12 months of follow-up. We analyze the changes in the two major subgroups of SF36—physical (MCS) and mental health (PCS). The age and gender distribution were similar between the groups on bDMARDs and tsDMARD. All observed indicators for disease control and QoL improve after the initiation of the biological or JAK inhibitor therapy. We also analyze the effect of therapies on DAS28—CRP, HAQ, SF-36 (PCS, MCS). Dispersion analysis for the effect of therapy measured through DAS28 between 1st and 3rd measurement shows a statically significant difference in between the average effect of therapies (p = 0.005). According to the average change in DAS28 between the first and third measurement the most effective is the golimumab (Median difference = 2.745), followed by rituximab (median = 2.305) and etanercept (median = 2.070). According to the average change in HAQ between first and third the most effective is tofacitinib (median 0.563), followed rituximab and infliximab (median 0.500 for both). Less effective in term of HAQ changes between the first and third measurement appears to be etanercept (median difference 0.250). All differences are statistically significant (p < 0.05). Regarding the changes in the QoL measured with SF-36 MCS and PCS there is no statistically significant differences in the average effect of different therapeutic agents. Tofacitinib is non-inferior in comparison to bDMARDs and improve both—disease activity and QoL in patients with RA.
... 38,39 This analysis showed that ≥ 20/50/70% improvement rates in Pain were generally comparable in TOF-treated and ADA-treated patients in both cohorts, as previously reported. 40 However, there was a small improvement in Pain in ACR70 responders receiving TOF vs ADA at month 3. Therefore, a specific effect on pain, other than through the established antirheumatic efficacy of TOF, cannot be concluded from this analysis. The finding that ≥ 20/50/70% improvement rates in PtGA and Pain were similar across treatments through month 6 confirm previous results over 3 months, and identify a close concordance of PtGA and Pain outcomes. ...
Objective
Evaluate the impact of tofacitinib on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA).
Methods
This posthoc analysis pooled data from RA phase III randomized controlled trials (RCTs) assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab, or placebo, with conventional synthetic disease-modifying antirheumatic drugs, and a phase IIIb/IV RCT assessing tofacitinib 5 mg BID monotherapy, tofacitinib 5 mg BID with methotrexate, or adalimumab with methotrexate. Outcomes included: proportions of patients achieving ACR20/50/70 responses and ≥20/50/70% improvement rates in ACR components at Week 2 and Months 1, 3, and 6; mean percent improvement in ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates, at Month 3, for ACR20/50/70 responders.
Results
Across treatment groups, ≥20/50/70% improvement rates were numerically higher for most physician- versus patient-reported measures. In phase III RCTs, at earlier timepoints, ≥50/70% improvements in Patient Global Assessment of Disease Activity, Pain and Clinician Global Assessment were similar. Among ACR20 responders receiving tofacitinib, mean percent improvements for tender and swollen joint counts were >70% at Month 3. CDAI/SDAI remission was achieved by 27.8–45.0% of ACR70 responders receiving tofacitinib at Month 3.
Conclusion
Among ACR20 responders treated with tofacitinib, physician-reported components particularly exceeded 20% response improvement. At Month 3, disease state generally did not corroborate ACR70 response criteria. Divergences between physician- and patient-reported measures highlight the importance of identifying appropriate patient-reported outcome targets to manage RA symptoms in clinical practice.
... In general, in these exploratory analyses, therapy with filgotinib 200 mg plus MTX or csDMARDs appeared to provide a greater benefit in each PRO measured for MTX-naïve, MTX-IR, and bDMARD-IR patients. The results of this analysis were similar to those observed in other Phase 3 trials of the JAK inhibitors tofacitinib, baricitinib, and upadacitinib [16][17][18][21][22][23][24][25][26]. ...
Background
The effects of filgotinib on patient-reported outcomes (PROs) from 3 trials in patients with active rheumatoid arthritis were investigated.
Methods
Methotrexate (MTX)-naïve patients received filgotinib 200 or 100 mg plus MTX (FIL200+MTX, FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX monotherapy through 52 weeks (NCT02886728). Patients with inadequate response (IR) to MTX (MTX-IR) received FIL200+MTX, FIL100+MTX, adalimumab 40 mg +MTX (ADA+MTX), or placebo (PBO)+MTX (rerandomized to FIL200+MTX or FIL100+MTX at week 24) through 52 weeks (NCT02889796). Patients with IR to biologic disease-modifying antirheumatic drugs (bDMARD-IR) received FIL200 or FIL100 or PBO with background stable conventional synthetic (cs) DMARDs for up to 24 weeks (NCT02873936). PROs included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) physical/mental component summary (PCS/MCS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and Patient Global Assessment of Disease Activity (PtGA). Data are reported as least-squares mean changes from baseline with standard error to the timepoint representing each study’s primary endpoint. All statistical comparisons are of filgotinib groups vs their respective control groups.
Results
At week 24, among MTX-naïve patients, change from baseline (standard deviation) in HAQ-DI was − 1.00 (0.03; P < 0.001) with FIL200+MTX, − 0.94 (0.04; P < 0.01) with FIL100+MTX, and − 0.91 (0.04; P < 0.05) with FIL200 alone compared with − 0.81 (0.03) with MTX alone. At week 12, among MTX-IR patients, change from baseline in HAQ-DI was − 0.69 (0.04; P < 0.001 vs PBO+MTX, P < 0.05 vs ADA) with FIL200+MTX, − 0.57 (0.04; P < 0.001 vs placebo) with FIL100+MTX, and − 0.60 (0.04) with ADA vs − 0.40 (0.04) with PBO+MTX. At week 12, among bDMARD-IR patients, change from baseline in HAQ-DI was − 0.50 (0.06; P < 0.001) with FIL200+csDMARD and − 0.46 (0.05; P < 0.001) with FIL100+csDMARD vs − 0.19 (0.06) with placebo+csDMARD. Changes in SF-36 PCS and MCS, FACIT-Fatigue, WPAI, and PtGA tended to favor filgotinib over PBO, MTX, and ADA. Greater proportions of patients experienced clinically meaningful differences with either dosage of FIL in combination with csDMARDs (including MTX) and with FIL200 monotherapy vs comparators.
Conclusions
Filgotinib provided improvements in PROs across patient populations. These findings suggest filgotinib can be an effective treatment option for patients with insufficient response to MTX or bDMARDs and patients who are MTX-naïve.
Trial registration
ClinicalTrials.gov, FINCH 1, NCT02889796, first posted September 7, 2016; FINCH 2, NCT02873936, first posted August 22, 2016, retrospectively registered; FINCH 3, NCT02886728, first posted September 1, 2016, retrospectively registered.
... Therefore, JAK inhibitors might have the potential to mitigate the depression observed in RA patients thereby improving their mental health. Several RA clinical trials with JAK inhibitors have reported patient-reported outcomes (particularly SF-36) [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] however were inconclusive about its benefit on mental health. Therefore, we aimed to determine the effect of JAK inhibitors on the mental health of RA patients by systematic review and meta-analysis of SF-36 mental component score (MCS). ...
... After removing duplicates and screening titles and abstracts, 548 full texts were screened. Fulltext scrutiny resulted in the selection of 19 studies involving 14,323 individuals for the final synthesis [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]44]. The PRISMA flowchart shows the selection of studies (Fig. 1). ...
... In six out of 19 studies [18,19,27,29,30,32], American College of Rheumatology (ACR) 1987 criteria were used for RA diagnosis, and in two studies [18,23] 2010 ACR/EULAR was used. The diagnostic criteria were not stated in other studies. ...
Introduction
Rheumatoid arthritis (RA) is a chronic debilitating illness, usually associated with mental health ailments. Literature reports contradictory observations about the association between recent RA pharmacotherapies and mental health. We systematically reviewed RA randomized control trials to synthesize the association between Janus kinases (JAK) inhibitors therapy and mental health.
Methods
We systematically searched clinical trials of JAK inhibitor intervention reporting mental health outcomes using short form-36 (SF-36) in PubMed, Embase, and Scopus databases from inception to February 2021. We have selected the studies and extracted the data, adhering to Preferred Reporting Items of Systematic reviews and Meta-Analysis (PRISMA) guidelines. We have pooled the mean change of SF-36 mental component score (MCS) between JAK inhibitors and comparator therapy with a 95% confidence interval.
Results
Of the 2915 searched studies for systematic review, 19 studies involving 14,323 individuals were included for the meta-analysis. The pooled mean reduction in SF-36 MCS scores (after minus before) with JAK inhibitors was 4.95 (4.41–5.48). The pooled mean difference of incremental mean change in SF-36 MCS score between JAK monotherapy and comparator was 1.53 (0.88–2.18). The improvement in SF-36 MCS scores with JAK inhibitor therapy is greater than the minimum clinically important difference (MCID) value of 2.5. However, on separate analysis with comparator drugs like methotrexate and standard treatment, the MCS scores did not exceeded the MCID value and were also not statistically significant.
Conclusions
JAK inhibitors results in clinically meaningful improvement in the mental health scores of the RA patients.
... Janus kinases play important roles in immune activation, hematopoiesis, and cancer cachexia [3,4]. Multiple trials have shown the efficacy of tofacitinib either as monotherapy or in combination with disease-modifying anti-rheumatic drugs (DMARDs) [5][6][7]. However, the long-term utility of tofacitinib in the treatment of rheumatoid arthritis (RA) has been modest. ...
Antineutrophil cytoplasmic antibodies (ANCA) vasculitis is common after the age of 50 years but it can occur at any age. There is a slight male preponderance and it is more common in Whites than Blacks but the black race confers a worse prognosis. The clinical features of ANCA vasculitis vary considerably. The manifestation of the disease depends on the organs affected, the chronicity of the disease, and how quiescent it is. Non-specific symptoms of malaise, fatigue, fever, and weight loss are common. Crescentic glomerulonephritis with focal necrosis is usually the pathology underlying renal disease. Manifestations of renal disease include hematuria and proteinuria which may progress to renal failure.
We present a case of a 75-year-old female who presented with acute worsening of renal function and nephrotic-range proteinuria with positive testing for p-ANCA after the recent commencement of treatment with tofacitinib. This prompted a suspicion of ANCA-vasculitis. The patient was started on pulse dose steroids and rituximab after kidney biopsy confirmation of ANCA-vasculitis with crescentic glomerulonephritis.
... With respect to patient-reported outcomes (PRO), each jakinib demonstrated numerical if not statistically significant improvement in multiple PRO versus adalimumab [6][7][8][9][11][12][13][14] and upadacitinib to abatacept [10]. Three trials assessed radiographic progression-no differences were seen comparing the jakinib to adalimumab [6][7][8]. ...
