scholarly journals Particulate Juvenile Articular Cartilage vs Osteochondral Allograft for Patellar Cartilage Defects: A Matched Cohort Analysis

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0051
Author(s):  
Niv Marom ◽  
Francesca Coxe ◽  
Dean Wang ◽  
Riley Williams ◽  
Gabriella Ode
Keyword(s):  
Patient Reported Outcomes ◽  
Cohort Analysis ◽  
Osteochondral Allograft ◽  
Cartilage Defects ◽  
Matched Cohort ◽  
Chondral Defects ◽  
Sf 36 ◽  
Cartilage Restoration ◽  
Significant Difference ◽  
Patient Reported

Objectives: Management of full-thickness cartilage defects of the patella remains a significant clinical challenge. Osteochondral allograft transplantation (OCA) is a reliable cartilage restoration procedure for large chondral defects of the knee. OCA reports good long-term outcomes for condylar defects but limited literature on outcomes of patellar defects. Since 2007, particulated juvenile articular cartilage (PJAC) has been used as an alternative method of cartilage restoration. PJAC has demonstrated promising early clinical outcomes, however, no studies have directly compared the clinical and patient reported outcomes of PJAC and OCA for management of full thickness chondral defects of the patella. Methods: Prospective data was collected for patients within our institutional cartilage registry who underwent OCA or PJAC using DeNovo NT (Zimmer-Biomet) for management of grade 4 cartilage defects of the patella. OCA patients were matched to PJAC patients by age, sex and BMI. Patient characteristics and minimum 2-year patient reported outcomes (PROMs) (Knee Outcome Survey-Activities of Daily Living (KOS-ADL) score, International Knee Documentation Committee (IKDC) score, Short Form 36 (SF-36) pain rating, and Marx Activity Rating Scale) and self-reported general overall knee condition were reported. Results: There were 28 patients eligible for analysis (14 OCA, 14 PJAC). Demographics of the two groups are outlined in Table 1. The mean age of the entire cohort was 38.4 +/- 11.4 years with a mean BMI of 24.6 +/- 3.1. One patient in each group had bipolar transplantation (patella and trochlea). OCA patients had more previous surgeries (1.4 vs 0.4) (p<0.01) and significantly larger chondral defects (4.6 cm2 vs. 2.5 cm2) (p<0.01) than PJAC patients. Patient reported outcomes are reported in Figure 1. IKDC, KOS-ADL and SF-36-Pain scores improved by 17, 16 and 14 points for OCA compared to 17, 11, and 23 points for PJAC at last follow-up (average 3.5 years) (p>0.05). Both groups met the published MCID for IKDC (17 pts) and KOS-ADL (10 pts) for osteochondral grafts. There was no significant difference between OCA and PJAC for all postoperative PROMs. The reoperation rate for OCA and PJAC was 36% and 50% respectively (p>0.05). There were 4 graft failures in the PJAC group (29%) and 1 failure in the OCA group (6%) (p>0.05). The failed OCA underwent manipulation and lysis of adhesions for post-operative stiffness at 7 months and arthroscopic synovectomy for synovitis at 8 months after OCA. The four failed PJAC patients underwent revision to OCA (at 8 months), chondroplasty of the graft (at 10 and 26 months), and revision to TKA (at 78 months). Reoperations are further described in Table 2. Conclusion: In a matched cohort analysis, both PJAC and OCA demonstrated significant clinical improvement in patient reported outcomes with no significant difference between the two groups at mean 3.5 years. Larger investigational studies are needed to determine optimal indications for use of PJAC versus OCA for management of focal cartilage defects of the patella. [Table: see text][Table: see text]

Equivalent 10-Year Outcomes After Implantation of Autologous Bone Marrow–Derived Mesenchymal Stem Cells Versus Autologous Chondrocyte Implantation for Chondral Defects of the Knee

2019 ◽  
Vol 47 (12) ◽  
pp. 2881-2887 ◽  
Author(s):  
Alex Quok An Teo ◽  
Keng Lin Wong ◽  
Liang Shen ◽  
Jia Ying Lim ◽  
Wei Seong Toh ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Tumor Formation ◽  
Chondral Defects ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Background: The use of bone marrow–derived mesenchymal stem cells (BMSCs) in cartilage repair procedures circumvents some of the limitations of autologous chondrocyte implantation (ACI), but long-term outcomes for this newer procedure are lacking. The authors previously reported comparable outcomes for the 2 procedures at 2-year follow-up. Purpose/Hypothesis: The purpose was to compare the long-term clinical outcomes of ACI versus BMSCs. It was hypothesized that there would be no significant difference between the groups in terms of patient-reported outcome scores and safety outcomes at 10-year follow-up. Study Design: Cohort study; Level of evidence, 2. Methods: Seventy-two patients who underwent either ACI or BMSC implantation—matched in terms of age and lesion site— were followed up to a median of at least 10 years. Patients were assessed with the 36-item Short Form Health Survey (SF-36), the International Knee Documentation Committee knee evaluation form, the Lysholm Knee Score, and the Tegner Activity Scale. In addition, information was obtained regarding any additional surgical procedures as well as safety data, with particular attention to infection and tumor formation. Results: There was an improvement in all patient-reported outcomes scores apart from the Mental Component Summary of the SF-36 after cartilage repair surgery. There was no significant difference in any of the patient-reported outcomes between cohorts at any time point. Six and 5 patients in the ACI and BMSC groups, respectively, underwent subsequent surgical procedures, including 1 total knee replacement in the BMSC group. None of the patients in either group developed any deep infection or tumor within the follow-up period. Conclusion: BMSC implantation used for the treatment of chondral defects of the knee appears to result in equivalent clinical outcomes to first-generation ACI at up to 10 years, with no apparent increased tumor formation risk.

No Difference in Outcomes Following Osteochondral Allograft with Fresh Precut Cores Compared to Hemi-Condylar Allografts

Cartilage ◽  
2021 ◽  
pp. 194760352110219
Author(s):  
Danielle H. Markus ◽  
Anna M. Blaeser ◽  
Eoghan T. Hurley ◽  
Brian J. Mannino ◽  
Kirk A. Campbell ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Knee Injury ◽  
Lesion Size ◽  
Osteochondral Allograft ◽  
Osteochondral Lesions ◽  
Radiographic Outcomes ◽  
Significant Difference ◽  
Patient Reported ◽  
The Mean

Objective The purpose of the current study is to evaluate the clinical and radiographic outcomes at early to midterm follow-up between fresh precut cores versus hemi-condylar osteochondral allograft (OCAs) in the treatment of symptomatic osteochondral lesions. Design A retrospective review of patients who underwent an OCA was performed. Patient matching between those with OCA harvested from an allograft condyle/patella or a fresh precut allograft core was performed to generate 2 comparable groups. The cartilage at the graft site was assessed with use of a modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system and patient-reported outcomes were collected. Results Overall, 52 total patients who underwent OCA with either fresh precut OCA cores ( n = 26) and hemi-condylar OCA ( n = 26) were pair matched at a mean follow-up of 34.0 months (range 12 months to 99 months). The mean ages were 31.5 ± 10.7 for fresh precut cores and 30.9 ± 9.8 for hemi-condylar ( P = 0.673). Males accounted for 36.4% of the overall cohort, and the mean lesion size for fresh precut OCA core was 19.6 mm2 compared to 21.2 mm2 for whole condyle ( P = 0.178). There was no significant difference in patient-reported outcomes including Visual Analogue Scale, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement, and Tegner ( P > 0.5 for each), or in MOCART score (69.2 vs. 68.3, P = 0.93). Conclusions This study found that there was no difference in patient-reported clinical outcomes or MOCART scores following OCA implantation using fresh precut OCA cores or size matched condylar grafts at early to midterm follow-up.

Six-month and 12-month patient outcomes based on inflammatory subphenotypes in sepsis-associated ARDS: secondary analysis of SAILS-ALTOS trial

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-216613
Author(s):  
Mohamed D Hashem ◽  
Ramona O Hopkins ◽  
Elizabeth Colantuoni ◽  
Victor D Dinglas ◽  
Pratik Sinha ◽  
...  
Keyword(s):  
Mental Health ◽  
Patient Reported Outcomes ◽  
Secondary Analysis ◽  
Cognitive Outcomes ◽  
Short Term ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Sepsis Trial

BackgroundPrior acute respiratory distress syndrome (ARDS) trials have identified hypoinflammatory and hyperinflammatory subphenotypes, with distinct differences in short-term outcomes. It is unknown if such differences extend beyond 90 days or are associated with physical, mental health or cognitive outcomes.Methods568 patients in the multicentre Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo were included and assigned a subphenotype. Among 6-month and 12-month survivors (N=232 and 219, respectively, representing 243 unique survivors), subphenotype status was evaluated for association with a range of patient-reported outcomes (eg, mental health symptoms, quality of life). Patient subsets also were evaluated with performance-based tests of physical function (eg, 6 min walk test) and cognition.FindingsThe hyperinflammatory versus hypoinflammatory subphenotype had lower overall 12-month cumulative survival (58% vs 72%, p<0.01); however, there was no significant difference in survival beyond 90 days (86% vs 89%, p=0.70). Most survivors had impairment across the range of outcomes, with little difference between subphenotypes at 6-month and 12-month assessments. For instance, at 6 months, in comparing the hypoinflammatory versus hyperinflammatory subphenotypes, respectively, the median (IQR) patient-reported SF-36 mental health domain score was 47 (33–56) vs 44 (35–56) (p=0.99), and the per cent predicted 6 min walk distance was 66% (48%, 80%) vs 66% (49%, 79%) (p=0.76).InterpretationComparing the hyperinflammatory versus hypoinflammatory ARDS subphenotype, there was no significant difference in survival beyond 90 days and no consistent findings of important differences in 6-month or 12-month physical, cognitive and mental health outcomes. These findings, when considered with prior results, suggest that inflammatory subphenotypes largely reflect the acute phase of illness and its short-term impact.

scholarly journals Should Chopart Amputation be Performed in Diabetic Foot Ulcer Patients?

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0011
Author(s):  
James D. Brodell ◽  
Judith F. Baumhauer ◽  
Benefict F. DiGiovanni ◽  
A. Samuel Flemister ◽  
John P. Ketz ◽  
...  
Keyword(s):  
Wound Healing ◽  
Diabetic Foot ◽  
Patient Reported Outcomes ◽  
High Rate ◽  
Measurement Information ◽  
Prosthesis Fitting ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Syme Amputation

Category: Diabetes, Midfoot/Forefoot Introduction/Purpose: Diabetic foot ulcers (DFU) with deep infections and osteomyelitis often lead to partial or complete limb loss. Determination of the appropriate level for amputation is challenging, and is a complex decision based on the patient’s function at baseline, extent of infection, vascular patency and comorbidities. Although Chopart amputation preserves greater limb length than Syme amputation, additional procedures, such as Achilles tenectomy and tendon transfers are necessary to optimize residual foot function. Challenges with wound healing and prosthesis fitting have been reported. We aimed to investigate the functional and clinical outcomes including patient reported outcomes of Chopart and Syme amputations. Methods: A query utilizing current procedural terminology (CPT) codes was performed to identify patients who had undergone Syme or Chopart amputations for diabetic foot infections by an academic orthopaedic group between August 2013 and September 2018. Twenty-two patients with average age of 59.8 (range, 28-79) years, comprising 18 Chopart amputations and 4 Syme amputations were identified. Demographic characteristics, body mass index, hemoglobin A1c, medical comorbidities, major and minor post-operative complications, unplanned admission or return to OR, revision surgeries, and time to receiving a brace or prosthesis information were compiled. After informed consent was obtained, subjects completed three Patient-Reported Outcomes Measurement Information Systems (PROMIS) instruments (Pain Interference (PI), Physical Function (PF), and Depression), and the SF-36. Unpaired student t-tests and Fisher’s exact test were utilized to compare patient cohorts. Statistical analysis was performed using Stata®. Results: The majority (17/18) of Chopart and half (2/4) of Syme patients developed complications including wound dehiscence and recurrent/persistent infection. Readmission and unexpected return to the OR for irrigation and debridement or revision occurred in 11/18 (61%) of Chopart and 2/4 (50%) of Syme patients. Revision amputations occurred in 10/18 (56%) Chopart patients (2 Syme, 8 BKA), and 1/4 (25%) Syme patients (BKA). Half of Chopart patients never received a prosthesis due to delayed wound healing and revision amputation. All Syme amputation patients received a prosthesis and resumed ambulation. The average time to prosthesis was 4.5 and 6.5 months for Syme and Chopart patients, respectively. There was no significant difference between Syme and Chopart patients in all PROMIS domains, or the SF-36 (p-values > 0.05) (Table 1). Conclusion: We found a high rate of complications and revision procedures in Chopart amputation patients. In our patient cohort, there was a high likelihood that a patient who underwent a Chopart amputation ultimately received a below knee amputation. Even after wound healing, patients with Chopart amputations may struggle with obtaining a prosthesis suitable for ambulation. Syme amputation patients were less likely to require revision amputation, and received a prosthesis more rapidly relative to Chopart amputation patients. The complication and revision rates of Chopart amputations indicate that surgeons should exercise judicious patient selection prior to performing these procedures.

Effect of Gender Differences on Patient-Reported Outcomes and Complications in Total Ankle Replacement

2021 ◽  
pp. 107110072098529
Author(s):  
Amanda N. Fletcher ◽  
Kush S. Mody ◽  
Samuel B. Adams ◽  
James K. DeOrio ◽  
Mark E. Easley ◽  
...  
Keyword(s):  
Gender Differences ◽  
Patient Outcomes ◽  
Inflammatory Arthritis ◽  
Patient Reported Outcomes ◽  
Total Ankle Replacement ◽  
Failure Rates ◽  
Ankle Replacement ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported

Background: The purpose of this study was to evaluate gender differences in patient outcomes and complications following total ankle replacement (TAR). Methods: Consecutive patients who underwent primary TAR from July 2007 through May 2016 were prospectively followed and retrospectively reviewed. Demographic, operative, patient-reported outcomes (PROs), and complication data were collected and analyzed. PROs included the visual analog scale (VAS), 36-Item Short-Form Health Survey (SF-36), American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot scale, and Short Musculoskeletal Function Assessment (SMFA). A total of 475 patients were evaluated, including 248 males (52.2%) and 227 females (47.8%) with an average of 56.8 months follow-up. Results: Women were more likely to have inflammatory arthritis (13.7% vs 2.8%; P < .01) and significantly worse preoperative SF-36 total, SF-36 mental health component, AOFAS total, AOFAS pain, SMFA function, and SMFA bother scores (all P < .05). Both genders demonstrated significant improvement in PROs at 1, 2, and 5 years. The magnitude of improvement was similar between genders for all PROs (all P < .05) with the exception of SF-36 physical function, which was greater in men. Females underwent more nonrevision reoperations (32.2% vs 22.6%; P = .0191), but there was no significant difference in failure rates (male 7.3% vs female 3.5%; P = .07). The reoperation and failure rates at 2 years postoperation were 10.1% and 1.6% for men and 18.5% and 0.9% for women, respectively. Conclusions: Women undergoing TAR were more likely to have worse preoperative PROs and higher rates of nonrevision reoperations, which remains true when controlling for their increased incidence of inflammatory arthritis. However, women reported similar improvements in PROs and had similar prosthetic survival rates as men. Increased understanding of these disparities, combined with gender-based interventions, may further advance patient outcomes. Level of Evidence: Level III, therapeutic, retrospective comparative series

scholarly journals FRI0048 NUMBER NEEDED TO TREAT TO ACHIEVE MINIMUM CLINICALLY SIGNIFICANT DIFFERENCES IN PATIENT-REPORTED OUTCOMES IN PATIENTS TREATED WITH BARICITINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bodily Pain ◽  
Health Assessment ◽  
Number Needed To Treat ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

scholarly journals Clinical and Immunological Efficacy of Mangosteen and Propolis Extracted Complex in Patients with Gingivitis: A Multi-Centered Randomized Controlled Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2604
Author(s):  
Jin-Young Park ◽  
Kyung-A Ko ◽  
Ji-Yeong Lee ◽  
Jae-Woon Oh ◽  
Hyun-Chang Lim ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Daily Intake ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Immunological Parameters ◽  
Significant Difference ◽  
Patient Reported ◽  
And Control

Background: Mangosteen and propolis extracts (MAEC) have been potential therapeutic agents known to exhibit powerful antioxidant and anti-inflammatory properties. The aim of the current study was to evaluate the clinical and immunological efficacy of MAEC as well as safety and patient-reported outcomes (PROMs) on gingivitis and incipient periodontitis. Methods: This study was performed on 104 patients diagnosed with gingivitis or incipient periodontitis. At baseline, the participants were randomly allocated to either the test group, with daily intake of a single capsule containing 194 mg of MAEC for eight weeks, or control group, with placebo. Clinical periodontal evaluation and immunological parameters from saliva and gingival sulcular fluid were assessed at baseline, four, and eight weeks. Individual PROMs were assessed by OHIP-14 questionnaires. Results: There was a significant difference of modified gingival index at four and eight weeks between the test and control groups. In the test group, crevicular interleukin (IL)-6 was reduced, and the salivary matrix metalloproteinase (MMP)-9 was increased after eight weeks. PROMs were improved up to four weeks compared to placebo. Conclusion: Oral administration of MAEC would have a potential to reduce gingival inflammation clinically and immunologically in the patients with gingivitis and incipient periodontitis.

scholarly journals SAT0121 PAIN AND OTHER PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DID OR DID NOT ACHIEVE TREATMENT RESPONSE BASED ON IMPROVEMENT IN SWOLLEN JOINTS IN TOCILIZUMAB CLINICAL TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 994.2-995
Author(s):  
A. Sebba ◽  
J. Han ◽  
S. Mohan
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Pain Score ◽  
Patient Reported Outcomes ◽  
Component Score ◽  
Link Type ◽  
Pain Scores ◽  
Sf 36 ◽  
Patient Reported ◽  
Nonresponder Group

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

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