Table 3.
Open in new tab

GRADE summary of findings table SRBmab vsPi/D

Outcome timeframeStudy results and measurementsAbsolute effect estimatesCertainty of the evidence (quality of evidence)Plain language summary
Pi/DBurosumab
Treatment-emergent adverse events (injection site reactions, hypersensitivity, dental, GI);
64 weeks		Based on data from 61 participants in 1 study.a
Follow-up 64 weeks		22 per 10059 per 100Moderate
Due to serious risk of biasb		Burosumab probably increases adverse events seen for the first time after administration of burosumab or Pi/D.
Difference: 38 more per 100 (CI 95% 14 more to 60 more)
Serious treatment-emergent adverse events;
64 weeks		Based on data from 61 participants in 1 study.0 per 1000 per 100Low
Due to serious risk of bias and serious imprecisionc		Burosumab may have little or no increase in serious treatment-emergent adverse events.
Difference: 0 fewer per 100 (CI 95% 6 fewer to 6 more)
Risk of progression to chronic kidney disease as inferred from decrease in nephrocalcinosis scoreMeasured by:
Renal ultrasound.
Lower better
nephrocalcinosis score (radiologic score).		78 per 10060 per 100Very low
Due to serious risk of bias, serious indirectness and serious imprecisiond		We are uncertain whether Burosumab avoids the progression to chronic kidney disease.
Difference: 18 fewer per 100 (CI 95% 68 fewer to 33 more)
Dental abscess;
64 weeks		Based on data from 61 participants in 1 study.9 per 10028 per 100Low
Due to serious risk of bias and serious imprecisione		Burosumab may increase dental abscess.
Difference: 19 more per 100 (CI 95% 1 fewer to 37 more)
Prevention of lower limb deformity as inferred from radiographic healing of rickets;
64 weeks		Measured by:
Radiographic Global Impression of Change global score of ≥ +2.0.
Based on data from 61 participants in 1 study.		17 per 10087 per 100Moderate
Due to serious indirectnessf		Burosumab probably prevents lower limb deformity.
Difference: 70 more per 100 (CI 95% 35 more to 100 more)
Improvement in pain interference with daily activities;
64 weeks		Measured by: PROMIS instrument.
Lower better
MID of 2.
Based on data from 35 participants in 1 study.g		1.29 LS Mean3.55 LS MeanVery Low
Due to serious risk of bias very serious imprecisionh		We are uncertain whether burosumab improves pain interference with daily activities.
Difference: MD 2.26 lower (CI 95% 6.61 lower to 2.09 higher)
Improvement in mobility as inferred from percent predicted distance walked over 6 minutes;
64 weeks		Measured by:
6-minute walking test.
High better
MID of 7%.
Based on data from 33 participants (≥5 years old) in 1 study.		2 % Mean9 % MeanVery Low
Due to serious risk of bias, serious imprecision, and serious indirectnessi		We are uncertain whether burosumab improves mobility
Difference: MD 7 more (CI 95% 0.01 more to 14.5 more)
Physical health QoL;
64 weeks		Measured by:
SF-10 (PHS-10)
caregiver-completed questionnaire.
High better
MID of 2.
Based on data from 35 participants in 1 study.		0.44 LS Mean5.93 LS MeanModerate
Due to serious risk of biasj		Burosumab probably improves physical health QoL.
Difference: MD 5.49 higher (CI 95% 4.12 higher to 6.8 higher)
Psychosocial health QoL;
64 weeks		Measured by: SF-10 (PSS-10) caregiver-completed questionnaire.
High better
MID of 1.
Based on data from 35 participants in 1 study.		1.44 LS Mean0.94 LS MeanLow
Due to serious risk of bias and serious imprecisionk		Burosumab may have little or no difference on psychosocial QoL.
Difference: MD 0.50 lower (CI 95% 1.29 lower to 0.3 higher)
Increase in height;
64 weeks		Measured by height-for-age Z-scores.
High better
MID of 0.1 SD.
Based on data from 61 participants in 1 study.		0.02 Z-score Mean0.17 Z-score MeanLow
Due to serious risk of bias and serious imprecisionl		Burosumab may increase height.
Difference: MD 0.14 higher (CI 95% 0.0 higher to 0.29 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in serum phosphorus;
64 weeks		Measured by: Serum sample (mg/dL)
Scale: 3.7-5.6.
High better
MID of 0.5.
Based on data from 61 participants in 1 study.		0.21 LS Mean0.91 LS MeanLow
Due very serious indirectnessm		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 0.7 higher (CI 95% 0.66 higher to 0.73 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in TmP/GFR;
64 weeks		Measured by: Urine sample (mg/dL)
Scale: 2.6-4.39.
High better
MID of 1.
Based on data from 61 participants in 1 study.		0.09 LS Mean1.16 LS MeanLow
Due to very serious indirectnessn		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 1.25 higher (CI 95% 1.19 higher to 1.30 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from decrease in ALP activity;
64 weeks		Measured by: Serum sample.
Lower better
MID of 5%.
Based on data from 61 participants in 1 study.		5 %Mean33 %MeanLow
Due to very serious indirectnesso		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 28 lower (CI 95% 37 lower to 19 lower)
Outcome timeframeStudy results and measurementsAbsolute effect estimatesCertainty of the evidence (quality of evidence)Plain language summary
Pi/DBurosumab
Treatment-emergent adverse events (injection site reactions, hypersensitivity, dental, GI);
64 weeks		Based on data from 61 participants in 1 study.a
Follow-up 64 weeks		22 per 10059 per 100Moderate
Due to serious risk of biasb		Burosumab probably increases adverse events seen for the first time after administration of burosumab or Pi/D.
Difference: 38 more per 100 (CI 95% 14 more to 60 more)
Serious treatment-emergent adverse events;
64 weeks		Based on data from 61 participants in 1 study.0 per 1000 per 100Low
Due to serious risk of bias and serious imprecisionc		Burosumab may have little or no increase in serious treatment-emergent adverse events.
Difference: 0 fewer per 100 (CI 95% 6 fewer to 6 more)
Risk of progression to chronic kidney disease as inferred from decrease in nephrocalcinosis scoreMeasured by:
Renal ultrasound.
Lower better
nephrocalcinosis score (radiologic score).		78 per 10060 per 100Very low
Due to serious risk of bias, serious indirectness and serious imprecisiond		We are uncertain whether Burosumab avoids the progression to chronic kidney disease.
Difference: 18 fewer per 100 (CI 95% 68 fewer to 33 more)
Dental abscess;
64 weeks		Based on data from 61 participants in 1 study.9 per 10028 per 100Low
Due to serious risk of bias and serious imprecisione		Burosumab may increase dental abscess.
Difference: 19 more per 100 (CI 95% 1 fewer to 37 more)
Prevention of lower limb deformity as inferred from radiographic healing of rickets;
64 weeks		Measured by:
Radiographic Global Impression of Change global score of ≥ +2.0.
Based on data from 61 participants in 1 study.		17 per 10087 per 100Moderate
Due to serious indirectnessf		Burosumab probably prevents lower limb deformity.
Difference: 70 more per 100 (CI 95% 35 more to 100 more)
Improvement in pain interference with daily activities;
64 weeks		Measured by: PROMIS instrument.
Lower better
MID of 2.
Based on data from 35 participants in 1 study.g		1.29 LS Mean3.55 LS MeanVery Low
Due to serious risk of bias very serious imprecisionh		We are uncertain whether burosumab improves pain interference with daily activities.
Difference: MD 2.26 lower (CI 95% 6.61 lower to 2.09 higher)
Improvement in mobility as inferred from percent predicted distance walked over 6 minutes;
64 weeks		Measured by:
6-minute walking test.
High better
MID of 7%.
Based on data from 33 participants (≥5 years old) in 1 study.		2 % Mean9 % MeanVery Low
Due to serious risk of bias, serious imprecision, and serious indirectnessi		We are uncertain whether burosumab improves mobility
Difference: MD 7 more (CI 95% 0.01 more to 14.5 more)
Physical health QoL;
64 weeks		Measured by:
SF-10 (PHS-10)
caregiver-completed questionnaire.
High better
MID of 2.
Based on data from 35 participants in 1 study.		0.44 LS Mean5.93 LS MeanModerate
Due to serious risk of biasj		Burosumab probably improves physical health QoL.
Difference: MD 5.49 higher (CI 95% 4.12 higher to 6.8 higher)
Psychosocial health QoL;
64 weeks		Measured by: SF-10 (PSS-10) caregiver-completed questionnaire.
High better
MID of 1.
Based on data from 35 participants in 1 study.		1.44 LS Mean0.94 LS MeanLow
Due to serious risk of bias and serious imprecisionk		Burosumab may have little or no difference on psychosocial QoL.
Difference: MD 0.50 lower (CI 95% 1.29 lower to 0.3 higher)
Increase in height;
64 weeks		Measured by height-for-age Z-scores.
High better
MID of 0.1 SD.
Based on data from 61 participants in 1 study.		0.02 Z-score Mean0.17 Z-score MeanLow
Due to serious risk of bias and serious imprecisionl		Burosumab may increase height.
Difference: MD 0.14 higher (CI 95% 0.0 higher to 0.29 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in serum phosphorus;
64 weeks		Measured by: Serum sample (mg/dL)
Scale: 3.7-5.6.
High better
MID of 0.5.
Based on data from 61 participants in 1 study.		0.21 LS Mean0.91 LS MeanLow
Due very serious indirectnessm		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 0.7 higher (CI 95% 0.66 higher to 0.73 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in TmP/GFR;
64 weeks		Measured by: Urine sample (mg/dL)
Scale: 2.6-4.39.
High better
MID of 1.
Based on data from 61 participants in 1 study.		0.09 LS Mean1.16 LS MeanLow
Due to very serious indirectnessn		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 1.25 higher (CI 95% 1.19 higher to 1.30 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from decrease in ALP activity;
64 weeks		Measured by: Serum sample.
Lower better
MID of 5%.
Based on data from 61 participants in 1 study.		5 %Mean33 %MeanLow
Due to very serious indirectnesso		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 28 lower (CI 95% 37 lower to 19 lower)

Bold: certainty of evidence level.

Abbreviations: ALP, alkaline phosphatase; MID, minimal important difference; Pi/D, phosphate/active vitamin D, QoL, quality of life; TmP/GFR, The ratio of tubular maximum reabsorption of phosphate (TmP) to glomerular filtration rate (GFR).

aPrimary study. Baseline/comparator Primary study. Supporting references (17)

bRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: no serious.P = .0017;

cRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: serious. Wide confidence intervals;

dRisk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias; Indirectness: serious. due to surrogate for patient-important outcomes; Imprecision: serious.P = .492, Wide confidence intervals;

eRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias; Imprecision: serious. Wide confidence intervals, P = .0623;

fRisk of Bias: not serious. due to blinded outcome assessors and objectivity of assessment tool; Indirectness: serious. due to surrogate for patient-important outcomes;

gSystematic review. Baseline/comparator Control arm of reference used for intervention. Supporting references (18).

hRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: very serious. Wide confidence intervals, P = .309;

iRisk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias; Imprecision: serious.P = .0496; Indirectness: serious, due to use of 6-MWT is a surrogate for patient-important outcome;

jRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: no serious.P = .0000;

kRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: serious. Wide confidence intervals; P = .229;

lRisk of Bias: serious. Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: no serious.P = .049;

mRisk of Bias: not serious due to objectivity of assessment tool; Indirectness: very serious. due to surrogate for patient-important outcome; Imprecision: no serious.P = .0000;

nRisk of Bias: not serious due to objectivity of assessment tool; Indirectness: very serious. due to surrogate for patient-important outcome; Imprecision: no serious.P = .0000;

oRisk of Bias: not serious due to objectivity of assessment tool; Indirectness: very serious. due to surrogate for patient-important outcome; Imprecision: no serious.P = .0000;

Table 3.
Open in new tab

GRADE summary of findings table SRBmab vsPi/D

Outcome timeframeStudy results and measurementsAbsolute effect estimatesCertainty of the evidence (quality of evidence)Plain language summary
Pi/DBurosumab
Treatment-emergent adverse events (injection site reactions, hypersensitivity, dental, GI);
64 weeks		Based on data from 61 participants in 1 study.a
Follow-up 64 weeks		22 per 10059 per 100Moderate
Due to serious risk of biasb		Burosumab probably increases adverse events seen for the first time after administration of burosumab or Pi/D.
Difference: 38 more per 100 (CI 95% 14 more to 60 more)
Serious treatment-emergent adverse events;
64 weeks		Based on data from 61 participants in 1 study.0 per 1000 per 100Low
Due to serious risk of bias and serious imprecisionc		Burosumab may have little or no increase in serious treatment-emergent adverse events.
Difference: 0 fewer per 100 (CI 95% 6 fewer to 6 more)
Risk of progression to chronic kidney disease as inferred from decrease in nephrocalcinosis scoreMeasured by:
Renal ultrasound.
Lower better
nephrocalcinosis score (radiologic score).		78 per 10060 per 100Very low
Due to serious risk of bias, serious indirectness and serious imprecisiond		We are uncertain whether Burosumab avoids the progression to chronic kidney disease.
Difference: 18 fewer per 100 (CI 95% 68 fewer to 33 more)
Dental abscess;
64 weeks		Based on data from 61 participants in 1 study.9 per 10028 per 100Low
Due to serious risk of bias and serious imprecisione		Burosumab may increase dental abscess.
Difference: 19 more per 100 (CI 95% 1 fewer to 37 more)
Prevention of lower limb deformity as inferred from radiographic healing of rickets;
64 weeks		Measured by:
Radiographic Global Impression of Change global score of ≥ +2.0.
Based on data from 61 participants in 1 study.		17 per 10087 per 100Moderate
Due to serious indirectnessf		Burosumab probably prevents lower limb deformity.
Difference: 70 more per 100 (CI 95% 35 more to 100 more)
Improvement in pain interference with daily activities;
64 weeks		Measured by: PROMIS instrument.
Lower better
MID of 2.
Based on data from 35 participants in 1 study.g		1.29 LS Mean3.55 LS MeanVery Low
Due to serious risk of bias very serious imprecisionh		We are uncertain whether burosumab improves pain interference with daily activities.
Difference: MD 2.26 lower (CI 95% 6.61 lower to 2.09 higher)
Improvement in mobility as inferred from percent predicted distance walked over 6 minutes;
64 weeks		Measured by:
6-minute walking test.
High better
MID of 7%.
Based on data from 33 participants (≥5 years old) in 1 study.		2 % Mean9 % MeanVery Low
Due to serious risk of bias, serious imprecision, and serious indirectnessi		We are uncertain whether burosumab improves mobility
Difference: MD 7 more (CI 95% 0.01 more to 14.5 more)
Physical health QoL;
64 weeks		Measured by:
SF-10 (PHS-10)
caregiver-completed questionnaire.
High better
MID of 2.
Based on data from 35 participants in 1 study.		0.44 LS Mean5.93 LS MeanModerate
Due to serious risk of biasj		Burosumab probably improves physical health QoL.
Difference: MD 5.49 higher (CI 95% 4.12 higher to 6.8 higher)
Psychosocial health QoL;
64 weeks		Measured by: SF-10 (PSS-10) caregiver-completed questionnaire.
High better
MID of 1.
Based on data from 35 participants in 1 study.		1.44 LS Mean0.94 LS MeanLow
Due to serious risk of bias and serious imprecisionk		Burosumab may have little or no difference on psychosocial QoL.
Difference: MD 0.50 lower (CI 95% 1.29 lower to 0.3 higher)
Increase in height;
64 weeks		Measured by height-for-age Z-scores.
High better
MID of 0.1 SD.
Based on data from 61 participants in 1 study.		0.02 Z-score Mean0.17 Z-score MeanLow
Due to serious risk of bias and serious imprecisionl		Burosumab may increase height.
Difference: MD 0.14 higher (CI 95% 0.0 higher to 0.29 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in serum phosphorus;
64 weeks		Measured by: Serum sample (mg/dL)
Scale: 3.7-5.6.
High better
MID of 0.5.
Based on data from 61 participants in 1 study.		0.21 LS Mean0.91 LS MeanLow
Due very serious indirectnessm		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 0.7 higher (CI 95% 0.66 higher to 0.73 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in TmP/GFR;
64 weeks		Measured by: Urine sample (mg/dL)
Scale: 2.6-4.39.
High better
MID of 1.
Based on data from 61 participants in 1 study.		0.09 LS Mean1.16 LS MeanLow
Due to very serious indirectnessn		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 1.25 higher (CI 95% 1.19 higher to 1.30 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from decrease in ALP activity;
64 weeks		Measured by: Serum sample.
Lower better
MID of 5%.
Based on data from 61 participants in 1 study.		5 %Mean33 %MeanLow
Due to very serious indirectnesso		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 28 lower (CI 95% 37 lower to 19 lower)
Outcome timeframeStudy results and measurementsAbsolute effect estimatesCertainty of the evidence (quality of evidence)Plain language summary
Pi/DBurosumab
Treatment-emergent adverse events (injection site reactions, hypersensitivity, dental, GI);
64 weeks		Based on data from 61 participants in 1 study.a
Follow-up 64 weeks		22 per 10059 per 100Moderate
Due to serious risk of biasb		Burosumab probably increases adverse events seen for the first time after administration of burosumab or Pi/D.
Difference: 38 more per 100 (CI 95% 14 more to 60 more)
Serious treatment-emergent adverse events;
64 weeks		Based on data from 61 participants in 1 study.0 per 1000 per 100Low
Due to serious risk of bias and serious imprecisionc		Burosumab may have little or no increase in serious treatment-emergent adverse events.
Difference: 0 fewer per 100 (CI 95% 6 fewer to 6 more)
Risk of progression to chronic kidney disease as inferred from decrease in nephrocalcinosis scoreMeasured by:
Renal ultrasound.
Lower better
nephrocalcinosis score (radiologic score).		78 per 10060 per 100Very low
Due to serious risk of bias, serious indirectness and serious imprecisiond		We are uncertain whether Burosumab avoids the progression to chronic kidney disease.
Difference: 18 fewer per 100 (CI 95% 68 fewer to 33 more)
Dental abscess;
64 weeks		Based on data from 61 participants in 1 study.9 per 10028 per 100Low
Due to serious risk of bias and serious imprecisione		Burosumab may increase dental abscess.
Difference: 19 more per 100 (CI 95% 1 fewer to 37 more)
Prevention of lower limb deformity as inferred from radiographic healing of rickets;
64 weeks		Measured by:
Radiographic Global Impression of Change global score of ≥ +2.0.
Based on data from 61 participants in 1 study.		17 per 10087 per 100Moderate
Due to serious indirectnessf		Burosumab probably prevents lower limb deformity.
Difference: 70 more per 100 (CI 95% 35 more to 100 more)
Improvement in pain interference with daily activities;
64 weeks		Measured by: PROMIS instrument.
Lower better
MID of 2.
Based on data from 35 participants in 1 study.g		1.29 LS Mean3.55 LS MeanVery Low
Due to serious risk of bias very serious imprecisionh		We are uncertain whether burosumab improves pain interference with daily activities.
Difference: MD 2.26 lower (CI 95% 6.61 lower to 2.09 higher)
Improvement in mobility as inferred from percent predicted distance walked over 6 minutes;
64 weeks		Measured by:
6-minute walking test.
High better
MID of 7%.
Based on data from 33 participants (≥5 years old) in 1 study.		2 % Mean9 % MeanVery Low
Due to serious risk of bias, serious imprecision, and serious indirectnessi		We are uncertain whether burosumab improves mobility
Difference: MD 7 more (CI 95% 0.01 more to 14.5 more)
Physical health QoL;
64 weeks		Measured by:
SF-10 (PHS-10)
caregiver-completed questionnaire.
High better
MID of 2.
Based on data from 35 participants in 1 study.		0.44 LS Mean5.93 LS MeanModerate
Due to serious risk of biasj		Burosumab probably improves physical health QoL.
Difference: MD 5.49 higher (CI 95% 4.12 higher to 6.8 higher)
Psychosocial health QoL;
64 weeks		Measured by: SF-10 (PSS-10) caregiver-completed questionnaire.
High better
MID of 1.
Based on data from 35 participants in 1 study.		1.44 LS Mean0.94 LS MeanLow
Due to serious risk of bias and serious imprecisionk		Burosumab may have little or no difference on psychosocial QoL.
Difference: MD 0.50 lower (CI 95% 1.29 lower to 0.3 higher)
Increase in height;
64 weeks		Measured by height-for-age Z-scores.
High better
MID of 0.1 SD.
Based on data from 61 participants in 1 study.		0.02 Z-score Mean0.17 Z-score MeanLow
Due to serious risk of bias and serious imprecisionl		Burosumab may increase height.
Difference: MD 0.14 higher (CI 95% 0.0 higher to 0.29 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in serum phosphorus;
64 weeks		Measured by: Serum sample (mg/dL)
Scale: 3.7-5.6.
High better
MID of 0.5.
Based on data from 61 participants in 1 study.		0.21 LS Mean0.91 LS MeanLow
Due very serious indirectnessm		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 0.7 higher (CI 95% 0.66 higher to 0.73 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from increases in TmP/GFR;
64 weeks		Measured by: Urine sample (mg/dL)
Scale: 2.6-4.39.
High better
MID of 1.
Based on data from 61 participants in 1 study.		0.09 LS Mean1.16 LS MeanLow
Due to very serious indirectnessn		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 1.25 higher (CI 95% 1.19 higher to 1.30 higher)
Improvement in the burden of symptoms caused by chronic hypophosphatemia as inferred from decrease in ALP activity;
64 weeks		Measured by: Serum sample.
Lower better
MID of 5%.
Based on data from 61 participants in 1 study.		5 %Mean33 %MeanLow
Due to very serious indirectnesso		Burosumab possibly improves the symptoms caused by chronic hypophosphatemia.
Difference: MD 28 lower (CI 95% 37 lower to 19 lower)

Bold: certainty of evidence level.

Abbreviations: ALP, alkaline phosphatase; MID, minimal important difference; Pi/D, phosphate/active vitamin D, QoL, quality of life; TmP/GFR, The ratio of tubular maximum reabsorption of phosphate (TmP) to glomerular filtration rate (GFR).

aPrimary study. Baseline/comparator Primary study. Supporting references (17)

bRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: no serious.P = .0017;

cRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: serious. Wide confidence intervals;

dRisk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias; Indirectness: serious. due to surrogate for patient-important outcomes; Imprecision: serious.P = .492, Wide confidence intervals;

eRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias; Imprecision: serious. Wide confidence intervals, P = .0623;

fRisk of Bias: not serious. due to blinded outcome assessors and objectivity of assessment tool; Indirectness: serious. due to surrogate for patient-important outcomes;

gSystematic review. Baseline/comparator Control arm of reference used for intervention. Supporting references (18).

hRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: very serious. Wide confidence intervals, P = .309;

iRisk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias; Imprecision: serious.P = .0496; Indirectness: serious, due to use of 6-MWT is a surrogate for patient-important outcome;

jRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: no serious.P = .0000;

kRisk of Bias: serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: serious. Wide confidence intervals; P = .229;

lRisk of Bias: serious. Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias; Imprecision: no serious.P = .049;

mRisk of Bias: not serious due to objectivity of assessment tool; Indirectness: very serious. due to surrogate for patient-important outcome; Imprecision: no serious.P = .0000;

nRisk of Bias: not serious due to objectivity of assessment tool; Indirectness: very serious. due to surrogate for patient-important outcome; Imprecision: no serious.P = .0000;

oRisk of Bias: not serious due to objectivity of assessment tool; Indirectness: very serious. due to surrogate for patient-important outcome; Imprecision: no serious.P = .0000;

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