Table 2.

Clinical, immune, and radiological assessments pre-sirolimus and pre-leniolisib treatments

Pre-sirolimus assessmentDetails pre-sirolimusPre-leniolisib assessmentDetails pre-leniolisib
Age 12 years 6 mo ​ 14 years 1 mo ​ 
Weight 29.4 kg −2.39 SD 34.8 kg −2.53 SD 
Height 133.1 cm −2.80 SD 147.9 cm −2.04 SD 
Clinical manifestation Severe recurrent infections Encephalitis—HHV-6
Sepsis—S. aureus
Recurrent otitis—P. aeruginosa
Pneumonia
RSV—M. pneumoniae 
Recurrent respiratory infections Upper respiratory infection not requiring hospitalization 
Alopecia areata Alopecia areata of the scalp, three patches, partial response to topical and systemic steroids Alopecia areata Smaller patches and fluctuating course with topical steroids 
Dysimmune hepatitis Hepatitis with mild cholestasis and normal liver function.
Anti-SM antibodies positivity and anti-LKM antibodies negativity.

Histology: Rich portal and lobular lymphocytic infiltrate with occasional interface expression with CD3+ as predominant component. 
Dysimmune hepatitis Residual self-limiting sporadic increase in transaminase levels 
Splenomegaly Spleen (US) 16 cm (bipolar diameter) with hypoechoic intraparenchymal areas with a maximum diameter of ∼19 mm Splenomegaly Spleen (US) 12 cm (bipolar diameter), heterogeneous echotexture due to the persistence of some hypoechoic areas with ill-defined margins, not clearly vascularized, and containing some hyperechoic components consistent with calcifications

Spleen (MRI) 13 cm, with some vaguely hypointense nodular-like areas are observed on T2W 
Persistent lymphadenopathies US (max dimensions)
LTC lymph nodes
L 21 × 9 mm, R 14 × 6 mm 
Fluctuating lymphadenopathies US (max dimensions)
LTC lymph nodes
R 15 × 6 mm; L 14 × 5 mm, reduced echogenicity and poor visualization of the hilum
Submandibular lymph nodes
R 20 × 6 mm; L 15 × 7 mm, regular echotexture
Axillary lymph nodes
R 15 × 3 mm; L 12 × 6 mm, regular echotexture
Supra clavicular lymph nodes
L 10 × 4 mm, regular echotexture

MRI (max dimensions)
LTC lymph nodes 2.3 cm
Armpit lymph nodes 1.9 cm 
Enteritis Alternating bowel habits with episodes of diarrhea

EGDs: Macroscopically normal findings
Colonoscopy: Findings normal except for aptha on the edge of the ileocecal valve

Histology: Increased neutrophilic, eosinophilic, lympho-plasmacytic, and granulocytic inflammatory component partially aggressive with plasma cells. Numerous foamy histiocytes in the left colon. Marked increase in duodenal intraepithelial T cells. Complete intestinal metaplasia of the gastric antrum 
Pulmonary interstitial disease CT scan: multiple areas of air trapping with subsegmental distribution in the right lower lobe. Hypoventilation. Bilateral basal fibrotic hypoventilatory streaks

Plethysmography: Air trapping with increased airway resistance. TLC: 2.72 L (78%), RV: 1.27 L (146%), RV/TLC: 44 (178%). FEV1/FVC 93%

DLCO 4.77 (73%) for VA reduced (2.09, 58%). Kco slightly increased (2.28, 124%) 
Thymic hyperplasia CT (diameter): 5 × 1.7 × 7 cm, cervical extension to the jugular veins, contrast enhancement 
Hematological 
Thrombocytopenia
Persistent leukopenia
Anemia 
Worst value recorded
PLT count, 124.000/mm3
WBC count, 2,020/mm3
Hb level, 9 g/dl 

Thrombocytopenia
Fluctuant leukopenia 
Worst value recorded
PLT count, 114.000/mm3
WBC count, 2,420/mm3 
Immune evaluation Major immunophenotype anomalies:
B cells (CD19+)
Reduced memory B
Slightly expanded transitional B cell
Slightly expanded CD21low
Senescent CD8 



15% (124 cell/µl)
1% (39% non-switched)
10%

4.7%

n.a. 
Major immunophenotype anomalies:
B cells (CD19+)
Memory B cell
Expanded transitional B cell
Slightly expanded CD21low
Expanded senescent CD8 



11% (120 cells/ul)
4% (89% non-switched)
20%

4.2%

13% 
IgG
IgM
IgA 
934 mg/dl preinfusion in IRT
257 mg/dl
68 mg/dl 
IgG
IgM
IgA 
1,007 mg/dl
66 mg/dl
38 mg/dl 
Medications ​ Dosage/frequency ​ Dosage/frequency 
SCIG replacement 15 g/mo SCIG replacement 15 g/mo 
PEP mask prescribed but not performed PEP mask prescribed but not performed 
TMP-SMX 160 mg/800 mg TMP-SMX 160 mg/800 mg 
Folic acid one tablet three times per wk Folic acid 1 tablet three times per wk 
Phytomenadione 5 mg/day twice per wk Phytomenadione 5 mg/day twice per wk 
Cholecalciferol 25,000 IU One vial every 3 wk Cholecalciferol 25,000 UI 1 vial every 3 wk 
​ ​ Sirolimus 3.5 mg/day 
​ ​ Testosterone 25 mg/mo intramuscular 
Pre-sirolimus assessmentDetails pre-sirolimusPre-leniolisib assessmentDetails pre-leniolisib
Age 12 years 6 mo ​ 14 years 1 mo ​ 
Weight 29.4 kg −2.39 SD 34.8 kg −2.53 SD 
Height 133.1 cm −2.80 SD 147.9 cm −2.04 SD 
Clinical manifestation Severe recurrent infections Encephalitis—HHV-6
Sepsis—S. aureus
Recurrent otitis—P. aeruginosa
Pneumonia
RSV—M. pneumoniae 
Recurrent respiratory infections Upper respiratory infection not requiring hospitalization 
Alopecia areata Alopecia areata of the scalp, three patches, partial response to topical and systemic steroids Alopecia areata Smaller patches and fluctuating course with topical steroids 
Dysimmune hepatitis Hepatitis with mild cholestasis and normal liver function.
Anti-SM antibodies positivity and anti-LKM antibodies negativity.

Histology: Rich portal and lobular lymphocytic infiltrate with occasional interface expression with CD3+ as predominant component. 
Dysimmune hepatitis Residual self-limiting sporadic increase in transaminase levels 
Splenomegaly Spleen (US) 16 cm (bipolar diameter) with hypoechoic intraparenchymal areas with a maximum diameter of ∼19 mm Splenomegaly Spleen (US) 12 cm (bipolar diameter), heterogeneous echotexture due to the persistence of some hypoechoic areas with ill-defined margins, not clearly vascularized, and containing some hyperechoic components consistent with calcifications

Spleen (MRI) 13 cm, with some vaguely hypointense nodular-like areas are observed on T2W 
Persistent lymphadenopathies US (max dimensions)
LTC lymph nodes
L 21 × 9 mm, R 14 × 6 mm 
Fluctuating lymphadenopathies US (max dimensions)
LTC lymph nodes
R 15 × 6 mm; L 14 × 5 mm, reduced echogenicity and poor visualization of the hilum
Submandibular lymph nodes
R 20 × 6 mm; L 15 × 7 mm, regular echotexture
Axillary lymph nodes
R 15 × 3 mm; L 12 × 6 mm, regular echotexture
Supra clavicular lymph nodes
L 10 × 4 mm, regular echotexture

MRI (max dimensions)
LTC lymph nodes 2.3 cm
Armpit lymph nodes 1.9 cm 
Enteritis Alternating bowel habits with episodes of diarrhea

EGDs: Macroscopically normal findings
Colonoscopy: Findings normal except for aptha on the edge of the ileocecal valve

Histology: Increased neutrophilic, eosinophilic, lympho-plasmacytic, and granulocytic inflammatory component partially aggressive with plasma cells. Numerous foamy histiocytes in the left colon. Marked increase in duodenal intraepithelial T cells. Complete intestinal metaplasia of the gastric antrum 
Pulmonary interstitial disease CT scan: multiple areas of air trapping with subsegmental distribution in the right lower lobe. Hypoventilation. Bilateral basal fibrotic hypoventilatory streaks

Plethysmography: Air trapping with increased airway resistance. TLC: 2.72 L (78%), RV: 1.27 L (146%), RV/TLC: 44 (178%). FEV1/FVC 93%

DLCO 4.77 (73%) for VA reduced (2.09, 58%). Kco slightly increased (2.28, 124%) 
Thymic hyperplasia CT (diameter): 5 × 1.7 × 7 cm, cervical extension to the jugular veins, contrast enhancement 
Hematological 
Thrombocytopenia
Persistent leukopenia
Anemia 
Worst value recorded
PLT count, 124.000/mm3
WBC count, 2,020/mm3
Hb level, 9 g/dl 

Thrombocytopenia
Fluctuant leukopenia 
Worst value recorded
PLT count, 114.000/mm3
WBC count, 2,420/mm3 
Immune evaluation Major immunophenotype anomalies:
B cells (CD19+)
Reduced memory B
Slightly expanded transitional B cell
Slightly expanded CD21low
Senescent CD8 



15% (124 cell/µl)
1% (39% non-switched)
10%

4.7%

n.a. 
Major immunophenotype anomalies:
B cells (CD19+)
Memory B cell
Expanded transitional B cell
Slightly expanded CD21low
Expanded senescent CD8 



11% (120 cells/ul)
4% (89% non-switched)
20%

4.2%

13% 
IgG
IgM
IgA 
934 mg/dl preinfusion in IRT
257 mg/dl
68 mg/dl 
IgG
IgM
IgA 
1,007 mg/dl
66 mg/dl
38 mg/dl 
Medications ​ Dosage/frequency ​ Dosage/frequency 
SCIG replacement 15 g/mo SCIG replacement 15 g/mo 
PEP mask prescribed but not performed PEP mask prescribed but not performed 
TMP-SMX 160 mg/800 mg TMP-SMX 160 mg/800 mg 
Folic acid one tablet three times per wk Folic acid 1 tablet three times per wk 
Phytomenadione 5 mg/day twice per wk Phytomenadione 5 mg/day twice per wk 
Cholecalciferol 25,000 IU One vial every 3 wk Cholecalciferol 25,000 UI 1 vial every 3 wk 
​ ​ Sirolimus 3.5 mg/day 
​ ​ Testosterone 25 mg/mo intramuscular 

Ab, antibody; DLCO, diffusing capacity of the lungs for carbon monoxide; EGDs, esophagogastroduodenoscopies; Hb, hemoglobin; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; HHV6, human herpesvirus 6; IRT, immunoglobulin replacement therapy; Kco, carbon monoxide transfer coefficient; LKM, liver kidney microsome; L, left; LTC, laterocervical; PEP, positive expiratory pressure; PLT, platelet; R, right; RSV, respiratory syncytial virus; RV, residual volume; SCIG, subcutaneous immunoglobulin; SM, smooth muscle; TLC, total lung capacity; TMP-SMX, trimethoprim-sulfamethoxazole; UI, international units; US, ultrasound; VA, alveolar volume; WBC, white blood cell.

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