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PubMedDate not supplied

Remission and radiographic progression in rheumatoid arthritis.

Complete remission, defined as the presence of clinical as well as radiographic remission, is the ultimate goal of treatment of rheumatoid arthritis (RA). Functional disability in patients with low disease activity is associated with joint inflammation and joint damage. Despite the methodologic problems of scoring radiographs, studies show that radiographic progression is an important outcome measure, and conventional radiography remains the best available method to assess it. Whether radiographic progression is entirely dependent on the presence of joint inflammation is a matter of debate; some evidence suggests that radiologic progression may continue in patients who appear clinically to be in remission. The potential availability of more effective drugs in the near future presents a need to further define and monitor progression of joint damage by more reliable methods. Better diagnosis of joint damage will assist in our quest to attain and document full remission in RA. Some newer techniques that provide direct assessments of metabolic activity in the inflamed joint appear to predict radiographic progression before it can be detected by conventional methods. Until these techniques are validated and assessed for predictive value, we would advocate that radiographic progression be added to existing criteria for clinical remission, in order to define remission in RA more comprehensively.

Arthritis, Rheumatoid↗
PubMed1995

Numerical scoring systems for the progression of osteoarthritis of the finger joints.

We developed methods to assess and to score progression of osteoarthritis (OA) of the distal and proximal interphalangeal (DIP and PIP) and metacarpophalangeal (MCP) finger joints. Thirty-six patients with osteoarthritis (OA) of the finger joints were followed for five years. Anteroposterior radiographs of the hands were obtained at the start of this prospective study and at yearly intervals. The scoring systems used were based on: -1- the increase in incidence of OA during consecutive years in previously normal joints. -2- the radiological progression of the anatomical lesions (changes in osteophyte growth, loss of joint space, subchondral cysts or sclerosis) in pathological finger joints. -3- the consecutive pathological phases recognized in the course of the disease. Significant increases in both the numbers of affected DIP, PIP and MCP joints per subject and the anatomical progression of the disease in the different finger joints of each individual patient were recorded during the 5-year follow-up. In approx. 40% of the patients the classical picture of OA was complicated by manifest erosive changes, which preceded a period in which repair phenomena in the 'eroded' finger joints led to generation of a new subchondral plate covered by cartilaginous tissue. Huge osteophytes were then responsible for the nodular aspect of the affected finger joints. OA of the finger joints in our patients was progressive in nature and went through predictable phases. Recognition and scoring of these phases allowed faster assessment of OA progression and led to the same conclusions as scoring the anatomical progression.

Cartilage, Articular↗
PubMed1994

Measurement and prediction of radiological progression in early rheumatoid arthritis.

OBJECTIVE: To compare radiological scoring systems in early RA, and then to determine if the rate of radiological progression in the first year of disease (RRP01) predicts the subsequent rate of progression up to 8 years (RRP1-8). METHODS: Hand and feet radiographs were performed at 0, 1, 2 and 8 years in 65 patients presenting with nonerosive RA and symptoms for less than 3 years. All films were scored by Sharp's method; Sharp, Larsen and carpometacarpal (CMC) ratio methods were compared in 23 patients. RESULTS: Significant change in score was detected over the first year using Sharp (median of 15.5 vs 7.5, p < 0.00002) and Larsen (30.5 vs 22.5, p < 0.0002), but not CMC ratio (1.13 vs 1.14, p = 0.07). Sharp had greater range and sensitivity of change, and had better inter and intraobserver reproducibility. RRP01 showed a skewed distribution (median 0.7 units/month; range -0.3 to +6.1). Spearman correlation between RRP01 and RRP1-8 was r = 0.57, p < 0.001. CONCLUSION: Both Sharp and Larsen indices are sensitive to change in the first year of RA, but Sharp has advantages of greater sensitivity and reproducibility: CMC ratio is not useful. Radiological progression rate in the first year correlates only moderately with subsequent rate of progression up to 8 years. This suggests that radiological progression is nonuniform and that different patterns of progression over time may exist.

Adult↗
PubMed1996

Analysis of risk factors for progression in patients with pathologically confined prostate cancers after radical retropubic prostatectomy.

PURPOSE: Up to 26% of patients with pathologically organ confined prostate cancer will experience clinical progression after radical prostatectomy. We attempted to identify patients at greatest risk for future clinical failure despite a favorable pathological outcome. MATERIALS AND METHODS: The study group included 904 patients treated with bilateral pelvic lymphadenectomy and radical retropubic prostatectomy for disease confined to the prostate gland. Preoperative serum prostate specific antigen (PSA), clinical stage, pathological grade and stage, and deoxyribonucleic acid (DNA) ploidy were evaluated by multivariate analysis to determine relative value in predicting treatment failure. A prognostic scoring system was created using the regression coefficients from the Cox multivariate model to classify patients further according to risk of progression. RESULTS: Preoperative PSA concentration, clinical stage, grade and DNA ploidy were significant univariate predictors of progression (p < 0.0001), whereas pathological stage was not (p = 0.2). Multivariate analysis identified pathological grade (p < 0.0001), preoperative serum PSA concentration (p = 0.0006) and DNA ploidy (p = 0.0089) as independent predictors of progression. The prognostic scoring system separated the patients into 5 distinct groups. Patients with the lowest score had a 92% progression-free survival rate at 5 years, compared to only 39% of those with the highest scores. CONCLUSIONS: Patients believed to be at higher risk for cancer progression despite having organ confined disease might be targeted for adjuvant therapy and closer surveillance, while those at low risk may be followed less often.

Adult↗
PubMed1996

Interobserver and intraobserver variability in the detection of glaucomatous progression of the optic disc.

PURPOSE: To evaluate the potential value of obtaining follow-up stereoscopic photographs on glaucoma suspects in identifying progressive optic nerve damage. METHODS: Nineteen sets of stereoscopic optic disc photographs, reflecting one eye from each of 19 patients at two time points, were selected from the records of subjects enrolled in the Glaucoma Screening Study. By consensus, three experts judged 13 of these eyes to have progressive glaucomatous optic nerve damage. Four other ophthalmologists who were masked to the expert panel evaluation then assessed glaucomatous progression in the same eyes. They were asked to evaluate glaucomatous progression in three ways: first, by drawing the optic nerve head appearance from initial stereoscopic photographs and later comparing their own drawings to follow-up stereoscopic photographs; second, by comparing serial stereoscopic photographs directly; and third, by comparing drawings of the optic nerve head made by another examiner to the follow-up photographs. RESULTS: Neither sensitivity nor specificity was consistently better for serial stereoscopic photographs than for drawings. Individual ophthalmologist agreement rates with the expert panel's determinations of progression were 23-62% when examiners compared their own drawings to follow-up photographs, 54-71% when examiners compared serial stereoscopic photographs, and 38-85% when comparing another ophthalmologist's drawings to follow-up photographs. CONCLUSION: Baseline stereoscopic photographs of the optic nerve head did not substantially improve recognition of progressive glaucomatous optic nerve damage when compared with the use of baseline drawings of the optic nerve head made from photographs in subjects who developed visual loss in the interim.

Disease Progression↗
PubMed1997

A study of racial differences in age at onset and progression of presbyopia.

BACKGROUND: This study investigated reported differences in age at onset and progression of presbyopia between black and white patients. METHODS: The records of 692 primary care patients (242 black and 450 white), ages 35 to 55 years, who received eye examinations at the University of Alabama at Birmingham School of Optometry (December 1, 1992 and May 31, 1993), were reviewed retrospectively. Regression models were used to compare age at onset and progression of presbyopia of study subjects with respect to race. Also, the effect of socioeconomic status (SES) was assessed for a subset of 373 subjects. RESULTS: No significant differences in the age at onset or progression of presbyopia were detected between black and white patients (p > 0.05). Similarly, there were no significant differences in age at onset and progression of presbyopia with respect to socioeconomic status. CONCLUSIONS: Contrary to previous studies, the onset and progression of presbyopia of black and white patients in this study population did not differ significantly. This result suggests other factors may play a role in previously reported variation of presbyopia in black and white patients. Similarly, variations in income status did not significantly impact the onset and progression of presbyopia. Further study is needed to corroborate or refute these findings.

Adult↗
PubMed1997

Promoters of progression of diabetic nephropathy: the relative roles of blood glucose and blood pressure control.

BACKGROUND AND AIMS: Hyperglycaemia is a strong risk factor for the development of renal disease in insulin dependent diabetes mellitus but it is uncertain whether it contributes to the progression of incipient or established nephropathy. The rigorous treatment of blood pressure in recent years may help uncover the contribution of hyperglycaemia, if any, to the progression of renal failure. Our aim therefore, was to assess in a current cohort of insulin dependent diabetic patients with diabetic nephropathy the relative importance of glycaemic control and blood pressure on disease progression. METHODS: All insulin dependent diabetic patients with persistent albuminuria (> 300 mg/24 h) attending the diabetic clinic at Guy's Hospital between 1977 and 1993 were recruited. Serial measurements of blood pressure, HbA1 and GFR were performed every 6 months until end-stage renal disease or death. Only patients with at least 1 year of follow up were analysed. The mean follow up period was 8 years (range 1.5-15.5 years). Baseline and time dependent variables were related to the rate of change of GFR using weighted linear regression and stepwise multiple regression analysis. The impact of each variable on the change of GFR with time was adjusted for the effect of other potentially confounding variables by analysis of co-variance. RESULTS: Patients had well-controlled blood pressure throughout the observation period (mean arterial pressure 97 +/- 8 mmHg) and the average rate of decline of GFR was 4.32 +/- 4.08 ml/min/year. In univariate analysis baseline and mean HbA1 were linearly related to the rate of decline of GFR (baseline r5-0.565, P < 0.001; mean r-0.5107, P < 0.001) with those with a higher HbA1 having a faster rate of progression. In stepwise multivariate analysis both mean HbA1 mean diastolic blood pressure (P < 0.0001 and P = 0.019, respectively) was significantly and independently related with a faster rate of decline of GFR. CONCLUSIONS: Worse glycaemic control is associated with a faster rate of progression of diabetic nephropathy once blood pressure is controlled. Thus improvement of glycaemic control in patients where good blood pressure control has been achieved may potentially further delay the progression of nephropathy.

Adolescent↗
PubMed1997

Dietary restriction reduces insulin-like growth factor I levels, which modulates apoptosis, cell proliferation, and tumor progression in p53-deficient mice.

Diet contributes to over one-third of cancer deaths in the Western world, yet the factors in the diet that influence cancer are not elucidated. A reduction in caloric intake dramatically slows cancer progression in rodents, and this may be a major contribution to dietary effects on cancer. Insulin-like growth factor I (IGF-I) is lowered during dietary restriction (DR) in both humans and rats. Because IGF-I modulates cell proliferation, apoptosis, and tumorigenesis, the mechanisms behind the protective effects of DR may depend on the reduction of this multifaceted growth factor. To test this hypothesis, IGF-I was restored during DR to ascertain if lowering of IGF-I was central to slowing bladder cancer progression during DR. Heterozygous p53-deficient mice received a bladder carcinogen, p-cresidine, to induce preneoplasia. After confirmation of bladder urothelial preneoplasia, the mice were divided into three groups: (a) ad libitum; (b) 20% DR; and (c) 20% DR plus IGF-I (IGF-I/DR). Serum IGF-I was lowered 24% by DR but was completely restored in the IGF-I/DR-treated mice using recombinant IGF-I administered via osmotic minipumps. Although tumor progression was decreased by DR, restoration of IGF-I serum levels in DR-treated mice increased the stage of the cancers. Furthermore, IGF-I modulated tumor progression independent of changes in body weight. Rates of apoptosis in the preneoplastic lesions were 10 times higher in DR-treated mice compared to those in IGF/DR- and ad libitum-treated mice. Administration of IGF-I to DR-treated mice also stimulated cell proliferation 6-fold in hyperplastic foci. In conclusion, DR lowered IGF-I levels, thereby favoring apoptosis over cell proliferation and ultimately slowing tumor progression. This is the first mechanistic study demonstrating that IGF-I supplementation abrogates the protective effect of DR on neoplastic progression.

Aniline Compounds↗
PubMed1997

Factors affecting progression of renal insufficiency.

The aim of this study was to analyze the factors affecting chronic renal insufficiency (CRI) progression at diagnosis (markers of progression), their spontaneous or therapy-induced behavior, and their relationship to CRI progression during follow-up. The underlying disease is the 'determinant factor' of progression and although clinical trials usually report crude cumulative renal survival without taking into account concomitant risk factors, it is known that diabetic nephropathy, polycystic kidney disease, and glomerulonephritis are more progressive than nephroangiosclerosis and interstitial nephropathy. Among the 'effect modifiers,' the baseline level of renal function, hypertension, and proteinuria are the most important. The adverse synergistic effects of proteinuria and high blood pressure have been confirmed, and the importance of correcting hypertension (systemic and glomerular) and proteinuria for slowing disease progression has also been demonstrated. The potential adverse role of a high-protein intake, strongly suggested by experimental studies and the clinical data of uncontrolled trials, has been challenged by the data coming from large controlled trials. The role of lipids needs to be clarified by prospective randomized trials, but the effects of therapeutic interventions aimed at correcting lipid abnormalities seem very promising. The association between the DD genotype of the gene encoding the angiotensin-converting enzyme (ACE) and an increased risk of renal function loss is under evaluation with the aim of identifying the patients who may most benefit from ACE inhibition.

Biomarkers↗
PubMed1997

Assessment of structure and function in progressive renal disease.

The incidence and prevalence rates of end-stage renal disease (ESRD) in the United States continue to increase. In 1995, the incidence rate was 262 per million population, with a point prevalence rate of 975 per million population. The exact number of individuals with abnormal renal function but not yet at end stage is difficult to assess. Crude estimates suggest that approximately 0.4% of the U.S. population has serum creatinine values greater than 2.0 mg/dl. In some sub-populations, such as African Americans, the estimate is + as high as 1.0%. The rate of progression, likewise, is difficult to assess. In general, renal manifestations of certain systemic diseases such as diabetes mellitus and systemic lupus erythematosus, and those with significant proteinuria (usually greater that 3.0 g/24 hr) seem to have a more rapid progressive course to end stage. If intervention is expected to be successful in halting or slowing down progression, accurate assessment of the early manifestations of renal disease, structure, and function need to be established. Currently accepted methods of assessment of renal disease include measurement of renal function such as serum creatinine and glomerular filtration rate, measurement of proteinuria, assessment of tubular function, glomerular sieving and permselectivity, radiologic imaging techniques, and evaluation of histo-morphometry. Interventions that have been shown to slow progression include control of hypertension, and treatment modalities that reduce proteinuria, such as, the use of angiotensin converting enzyme inhibitors. Further clinical and basic science studies are needed to accurately define the important predictors of progression, and interventions that are effective in slowing or halting progression.

Animals↗
PubMed1997

[The progression of primary operated glaucoma].

OBJECTIVE: Study of the causes responsible for glaucoma progression in patients operated for glaucoma. MATERIAL AND METHOD: A series of 185 patients operated for primary open angle glaucoma were followed up for a mean period of 3.2 years. 46 patients had evidence of glaucoma progression: insufficient filtration was recognized as the cause in 23 patients, while blockage of the filtering bleb was responsible for the rest of 23 cases. RESULTS: Progression of glaucoma was detected in 19.32% of patients with functional filtering bleb; 44.1% of patients with intraocular pressure between 16 and 21 mmHg did not show disease progression; 8 out of 23 patients needed a new trabeculectomy; internal obstruction of the bleb was demonstrated in 8 cases; 4 patients needed additional medical therapy; internal revision of the bleb (3 cases) and a new trabeculectomy gave the best results; external obstruction of the bleb was found in 15 patients; 7 had a diffuse fibrovascular proliferation and 8 had an encapsulated bleb. We used a new trabeculectomy for diffuse fibrovascular proliferation and a cystotomy or a cystectomy for encapsulated bleb. The results were good in almost all cases. CONCLUSIONS: Glaucoma progression appears even with postoperative intraocular pressures within statistical normality; identification of the causes responsible for glaucoma progression insures individualized treatment with constant good results.

Combined Modality Therapy↗
PubMed1997

[Positive margins. Surgical techniques and progression after radical prostatectomy].

OBJECTIVE: Repercussion of positive surgical borders (SB+) after radical prostatectomy (RP) in the oncological management of this condition is not yet well defined. The article analyzes their incidence and relevance for tumoral progression. MATERIAL AND METHODS: A review of 204 RPs is made. The erectors' preservation technique has been preferentially used until 1994, while the extracapsular standard technique was used afterwards. SB+ have been correlated to pre-operative PSA, Gleason grade, pathological stage and surgical technique. Also, status of borders has been correlated to progression. RESULTS: SB+ have been detected in 88 patients (43.13%) and were significantly correlated to the pathological stage and Gleason, but not to pre-operative PSA. Although no relation has been ascribed to the surgical technique used in terms of incidence, a decrease of posterolateral borders from 51.8% to 26.2% has been noticed using the extracapular standard technique. Progression is greater in SB+ patients (27.2% vs. 19.2%) but the difference is not statistically significant. SB+ patients who have progressed had all extracapsular tumour, 66% poorly differentiated. CONCLUSIONS: There is a decrease of posterolateral SB+ when the extracapsular standard technique is used. A correlation between presence of SB+ and progression has not been established. No patients with intracapsular tumour and SB+ has progressed. Therefore, it can be inferred his factor has little influence on the evolution of these patients.

Adenocarcinoma↗
PubMed1998

Triglyceride-rich lipoproteins and progression of atherosclerosis.

AIMS: To present data from the Cholesterol Lowering Atherosclerosis Study (CLAS) and the Monitored Atherosclerosis Regression Study (MARS) demonstrating the relationship between triglyceride-rich lipoproteins and progression of atherosclerosis. METHODS AND RESULTS: CLAS and MARS were randomized, placebo-controlled, arterial imaging trials designed to determine the effects of lipid lowering on the progress of atherosclerosis using coronary angiographic and carotid arterial wall intima-media thickness measurement end points. Included in each of these trials were specific measurements of triglyceride-rich lipoproteins in addition to the traditional lipid measurements. CONCLUSIONS: CLAS and MARS indicate that specific triglyceride-rich lipoproteins such as VLDL, IDL, apolipoprotein B-containing lipoprotein particles (i.e. lipoprotein Bc), and markers of triglyceride-rich lipoprotein metabolism (i.e. apolipoprotein C-III) are significantly related to progression of atherosclerosis. These specific triglyceride-rich lipoproteins are associated with the progression of atherosclerosis independently of HDL cholesterol levels. Importantly, there appears to be a differential effect of triglyceride-rich lipoproteins and cholesteryl-ester rich lipoproteins (i.e. LDL cholesterol) on the progression of mild/moderate and severe coronary artery lesions, respectively. This association not only suggests that certain risk factors may act early and others late in the athersclerotic process, but that triglyceride-rich lipoproteins are associated with progression of the lesions (mild/moderate lesions) which are predominantly responsible for clinical coronary events.

Angiography↗
PubMed1998

HLA markers and progression in psoriatic arthritis.

OBJECTIVE: To investigate whether the addition of all serologically defined HLA antigens to a baseline model further influences the predisposition to disease progression in psoriatic arthritis (PsA). METHODS: Patients with PsA followed prospectively over 19 years were studied. Clinical and laboratory assessments of both active inflammation and clinical damage were performed at 6 month intervals according to a standard protocol. Progression of damage was defined as transition to higher damage states defined by the number of damaged joints. A model that provides estimates of the ratio of transition rates for an individual with the antigen versus one without, and examines the antigen effect on each of the 3 transition rates, was used. HLA antigens were examined in groups by loci under the assumption of common effects across transitions when added to the basic model. The significance levels were examined in comparison with Bonferroni type corrections. Likelihood ratio chi-squared statistics were used as a basis for the significance levels. In total, 292 patients with PsA were included in the study. RESULTS: Only HLA-B22 was added to the original model, which includes HLA-B39, providing risk for progression in early stages, HLA-B27 in the presence of HLA-DR7 providing risk for progression through all states, and DQw3 providing increased risk in the absence of DR7, while in the presence of DR7 it provides "protection." HLA-B22 provides protection from disease progression through all states. CONCLUSION: This study extends our report that HLA antigens serve as markers for disease progression in PsA.

Adolescent↗
PubMed1998

p53 and RB expression predict progression in T1 bladder cancer.

The optimal clinical management of minimally invasive (stage T1) bladder cancer is controversial. T1 bladder cancers share characteristics of both noninvasive (Ta) papillary cancer and high stage, muscle-invasive bladder cancers. Patients with T1 bladder cancer have a higher risk of cancer progression and death than do patients with Ta bladder cancer. However, this risk is much lower than that of patients with high-stage bladder cancers. Methods of identifying T1 bladder cancer patients at greatest risk for progression may significantly improve clinical management. We retrospectively evaluated two tumor suppressor genes, p53 and RB, as potential prognostic markers for progression in a cohort of 45 patients with pT1 bladder cancer. Median follow-up for these individuals was greater than 3.5 years. Of this group, 58% had altered p53 expression based on positive p53 immunostaining. Three patterns for RB nuclear protein staining were observed: absent, heterogeneous (normal), and strongly homogeneous. Progression-free survival was similar for patients with loss of RB protein expression and those with apparent overexpression of RB protein. Therefore, both staining patterns were considered abnormal. Patients with normal expression of both proteins (i.e., p53 negative and RB heterogeneously positive) had an excellent outcome, with no patient showing disease progression, whereas patients with abnormal expression of either or both proteins had a significant increase in progression (P = 0.04 and P = 0.005, respectively). These data support the stratification of T1 bladder cancer patients based on p53 and RB nuclear protein status and suggest that patients with normal protein expression for both genes can be managed conservatively, whereas patients with alterations in one and particularly both genes require more aggressive treatment.

Cohort Studies↗
PubMed1998

Elevated levels of versican but not decorin predict disease progression in early-stage prostate cancer.

Patients with clinically localized prostate cancer who might be cured by aggressive management are not easily identified using current clinical information. Additional, more accurate, biomarkers of tumor behavior need to be identified to improve clinical outcome. Our previous studies indicated that the concentration of the glycosaminoglycan chondroitin sulfate in prostatic stroma might be a useful biomarker of disease progression in early-stage prostate cancer. In this study, two chondroitin sulfate proteoglycans, versican and decorin, were investigated. Versican and decorin were immunolocalized to the periacinar and peritumoral fibromuscular stroma in sections of nonmalignant and malignant human prostate tissues. Video image measurements indicated that the concentrations of both proteoglycans were increased in the prostatic tissue of men with early-stage prostate cancer compared with tissue from men without cancer (P = 0.0006). Cox's univariate analysis indicated that increases in versican concentration but not in that of decorin were associated with increased risk of prostate-specific antigen (PSA) progression. Versican concentration was compared with other clinical or biological features of prognosis in two-variable regression analyses. Versican and serum PSA concentrations were independent predictors of PSA progression. Versican was a stronger prognostic factor than tumor grade, and it could predict outcome for patients with moderately differentiated tumors. Patients with low versican concentration had significantly better progression-free survival than patients with high levels of versican (Kaplan-Meier plot, 89% versus 27% PSA progression-free at 5 years, respectively; P = 0.0001). We conclude that the measurement of prostatic concentrations of versican, a molecule with reported anticellular adhesive properties, may be a useful marker of disease progression in patients with early-stage prostate cancer and that further study of versican in other patient cohorts is warranted.

Aged↗
PubMed1998

Angiographic evidence for the role of triglyceride-rich lipoproteins in progression of coronary artery disease.

Recent development in angiographic technology have enabled quantitative assessment of the effects of treatment on coronary arterial lesions. A meta-analysis of 12 angiographic studies showed that treatment to reduce low density lipoprotein (LDL) cholesterol levels decreases angiographic progression of coronary artery disease (CAD) by one-third, and increases the chance of lesion regression two-fold. However, these studies also show that the response to treatment to LDL cholesterol levels varies according to the severity of the coronary artery stenosis; lesions were seen to regress with treatment only if there was > 50% coronary artery stenosis at baseline. Other variables that have been implicated in CAD progression include intermediate density lipoprotein (IDL) non-high density lipoproteins (non-HDL) cholesterol and very low density lipoproteins (VLDL). Levels of IDL have been shown to decrease to a greater extent in patients whose lesions did not progress than in patients showing lesion progression. In untreated patients, an increase in non-HDL cholesterol was associated with an increase in risk of disease progression. In contrast, the most important predictor in treated patients was apo CIII (a marker of triglyceride-rich lipoprotein metabolism). Possible mechanistic links between triglyceride levels and CAD progression are discussed.

Apolipoprotein C-III↗
PubMed2003

MRI metrics as surrogate endpoints for EDSS progression in SPMS patients treated with IFN beta-1b.

BACKGROUND: Although metrics derived from conventional MRI (cMRI) are widely used as outcome measures in clinical trials of MS, no formal study has been performed to validate cMRI metrics as surrogate endpoints for disability progression in MS. METHODS: A validation procedure was applied to the clinical and MRI data collected in the context of the European randomized, double-blind, placebo-controlled trial of interferon beta-1b (IFNbeta-1b) in patients with secondary progressive MS. The Prentice operational criteria were used to assess surrogacy for the number of active lesions seen on the first year T2-weighted MRI scans and the percentage T2 lesion volume change between the baseline and the first year MRI scans. The primary clinical outcome was disability at study exit (3 years), adjusted for the baseline disability. RESULTS: The number of active T2 lesions and the T2 lesion volume percentage change over the first year of the study accounted for 57% of the treatment effect on disability progression over the entire study duration. On the contrary, the same cMRI metrics accounted for 79% of the treatment effect on the relapse rate. CONCLUSIONS: This study shows that the beneficial effect of IFNbeta-1b on disability accumulation in patients with secondary progressive MS is, to a large extent, independent of the changes detected using cMRI. As a consequence, cMRI metrics should not be used as a stand-alone measure of outcome in phase III trials of IFNbeta in secondary progressive MS.

Biomarkers↗